NOAEL Studies
Preservative
Ethyl Lauroyl Arginate HCl NOAEL Studies
INCI: ETHYL LAUROYL ARGINATE HCL
CAS: 60372-77-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 2000 | ppm | rat | oral | 52 week | Chronic | SCCP; Kilpatrick, H.; Akintomide, A.; Waterson, L. Lauric arginate. Toxicity study by dietaryadministration to CD rats for 52 weeks. Huntingdon Life Science. Report, Studynumber LMA 050/042556, November, 2005. (Annex 8) |
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =47 | mg/kg bw/day | Rat | oral: unspecified | 91 days | subchronic | EFSA AFC - 2007 - OutputID 297 - clinical chemistry - immunotoxicity - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive - doi:10.2903/j.efsa.2007.511 |
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =0.5 | mg/kg bw/day | Consumers | - | - | ADI | EFSA AFC - 2007 - OutputID 297 - Consumers - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive - doi:10.2903/j.efsa.2007.511 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =0.5 | mg/kg bw/day | Consumers | - | - | ADI | EFSA AFC - 2007 - OutputID 297 - Consumers - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive - doi:10.2903/j.efsa.2007.511 |
SCCS_vision_codex 188 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =20.2 | % | rat | - | - | irritation | {"citation":"Ref.: 16 Mirenat-N Guideline : OECD No","dose":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females.","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, eg, adjacent to the entry of the oesophagus. The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg for males and 401 for females of Ethyl lauroyl arginate HCl/kg/day. Ref.: 16 Mirenat-N Guideline : OECD No.408 (1981) Species/strain : Rat, Crl: CD BR Group size : 10 males + 10 females per dose Active ingredient : 20.2% Ethyl lauroyl arginate HCl Test substance : Mirenat-N (21.6% of LAE) Batch : 0000001, 4-12-95 Purity : 20.2% Ethyl lauroyl arginate HC1 Dose : 0, 3200, 12800 and 50000 ppm Mirenat-N (equivalent to 646, 2586 and 10100 ppm Ethyl lauroyl arginate HC1) Observ.","page":23,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_001"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 34 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate","page":34,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_002"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"citation":"Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","page":36,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_003"} |
| SCCS_vision_codex | NOAEL | =93.2 | % | rat | - | - | irritation | {"citation":"Ref.: 31 3","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity","page":38,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_005"} |
| SCCS_vision_codex | NOAEL | =837 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_007"} |
| SCCS_vision_codex | NOAEL | =12 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_008"} |
| SCCS_vision_codex | NOAEL | =unclear:orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” | - | - | oral | - | reproductive toxicity | {"dose":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data.","effect":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_009"} |
| SCCS_vision_codex | NOAEL | =346 | mg/kg bw/day | rat | - | - | irritation | {"citation":"Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No","dose":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female.","effect":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800","page":26,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_001"} |
| SCCS_vision_codex | NOAEL | =6000 | ppm | - | oral | 28 day | repeated dose toxicity | {"citation":"Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","dose":"The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship.","effect":"on and signs of healing. The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship. In support of this, there were no treatment related effects on the bone marrow and a lack of any histopathology findings associated with the lymphoid tissues. The study authors concluded that no significant toxicological effects were observed in the animals receiving 6000 ppm or 2000 ppm LAE in the diet. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day (271 mg/kg bw/day Ethyl lauroyl arginate HCl in the males and 393 mg/kg bw/day in the females). The corresponding LOAEL was 18000 ppm equivalent to 907 mg/ kg bw/day and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","page":29,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_003"} |
| SCCS_vision_codex | NOAEL | =13 | - | rat | - | sub-chronic | repeated dose toxicity | {"dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","effect":"omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre","page":30,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | NOAEL study | {"dose":"The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","effect":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 31 induced. The high inter-individual variation seen in plasma LAE concentrations in the toxicokinetic data would suggest that similar variation could be feasible for the blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be us","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_007"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A","dose":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses:","effect":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses: There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl l","page":41,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_010"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","page":43,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_012"} |
| SCCS_vision_codex | NOAEL | =0 | - | - | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_014"} |
| SCCS_vision_codex | NOAEL | =7 | - | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage.","effect":"07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_016"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 36","dose":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls.","effect":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls. The magnitude of the difference reduced as age increased and was not accompanied by any macroscopic changes or microscopic changes in F0 and F1 adult animals so that the effect was therefore considered to be of no toxicological importance. Conclusion The study authors considered the NOAEL for reproductive performance in the Sprague Dawley CD rat to be 15000 ppm LAE, which was equivalent to at least 1073 mg/kg bw/day of LAE (946 mg/kg bw/day of Ethyl lauroyl arginate HCL) based on the lowest average intake by adult rats before pairing and up to 2600 mg/kg bw/day of LAE 92293 mg/kg bw/day of Ethyl lauroyl arginate HCL) for females during lactation. Ref.: 36","page":48,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_017"} |
| SCCS_vision_codex | NOAEL | =1.19 | mg/kg/d | rat | oral | chronic | dermal absorption | {"dose":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.","effect":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | dermal | - | dermal absorption | {"dose":"uroyl arginate of 271 mg/kg bw/day was used.","effect":"uroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_020"} |
| SCCS_vision_codex | NOAEL | =1.24 | mg/kg/d | human | inhalation | chronic | reproductive toxicity | {"dose":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applie...","effect":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_021"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | human | inhalation | chronic | repeated dose toxicity | {"dose":"0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14.","effect":"w/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation i","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_022"} |
| SCCS_vision_codex | NOAEL | =837 | - | - | oral | sub-chronic | repeated dose toxicity | {"effect":"on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_023"} |
| SCCS_vision_codex | NOAEL | =106 | mg/kg bw/day | rat | - | 90-day | NOAEL study | {"citation":"(ref 18)","dose":"Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...","effect":"pinion on ethyl lauroyl arginate as a food additive considered the non-glandular forestomach lesions were not indicative of systemic toxicity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no co","page":56,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_024"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | {"dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"-arginine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irrita","page":57,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_026"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | oral | - | NOAEL study | {"effect":"Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_030"} |
| SCCS_vision_codex | NOAEL | =28 | - | - | - | 28 day | NOAEL study | {"effect":"Unlabeled table on page 31: 28 day | LAE | Han, Wistar | M | 2120 | 3098 | 3850 | /","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_034"} |
| SCCS_vision_codex | NOAEL | =55 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_035"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | oral | chronic | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used.","effect":"SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 26 3.3.5. Safety evaluation (including calculation of the MoS) The Margin of Safety for dermal application of cosmetics was recalculated based on the new dermal absorption study and the revised exposure values for cosmetic products in the SCCS Notes of guidance, 7th revision. CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used. 0.4% preservative use only Dermal absorption of 3.0% (mean absorption of 2.1% +1 SD (0.9) was used for the calculation of the MOS. Only permitted product categories are included in this calculation and without those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products a","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"ut those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"gredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodo","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_003"} |
| SCCS_vision_codex | NOAEL | =26 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Ch","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on W","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_003"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"SCCS/1519/13 Revision of the opinion on Ethyl lauroyl arginate HCl - submission IV (P95) ___________________________________________________________________________________________ 13 Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.0897 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Ref. 6)","dose":"6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included:","effect":"]) = 13.23 g/day C = 0.4% DAp (%) = 3% (Ref. 6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included: SED = 0.0575 + 0.02646 + 0.00574 = 0.08970 mg/kg bw/d MoS for cosmetic uses of Ethyl lauroyl arginate HCl = 3021 bw/day mg/kg 0.0897 bw/day mg/kg 271 = SCCS Comment No systemic effects are expected at all concentrations and uses requested. No correction value for the NOAEL was utilized because of the high MoS-value.","page":18,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_007"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_008"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_010"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_011"} |
| SCCS_vision_codex | NOAEL | =271 | - | - | oral | Chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Chronic | LAE | Sprague Dawley | M | 93.5 | 271 | 800 | 271","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_001"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | 28 day | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...","effect":"in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | - | Chronic | repeated dose toxicity | {"dose":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the...","effect":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_005"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutagenicity/genotoxicity Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_006"} |
| SCCS_vision_codex | NOAEL | =56 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.","effect":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.442 | mg/kg bw/day | - | oral | 9 years | NOAEL study | {"dose":"To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day.","effect":"ermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children, 3 to 9 years old’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. However, no continuo","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_009"} |
| SCCS_vision_codex | NOAEL | =95 | - | - | dermal | - | NOAEL study | {"effect":"consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of","page":20,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_013"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_016"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_017"} |
| SCCS_vision_codex | NOAEL | =20.2 | % | rat | - | - | irritation | {"citation":"Ref.: 16 Mirenat-N Guideline : OECD No","dose":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females.","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, eg, adjacent to the entry of the oesophagus. The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg for males and 401 for females of Ethyl lauroyl arginate HCl/kg/day. Ref.: 16 Mirenat-N Guideline : OECD No.408 (1981) Species/strain : Rat, Crl: CD BR Group size : 10 males + 10 females per dose Active ingredient : 20.2% Ethyl lauroyl arginate HCl Test substance : Mirenat-N (21.6% of LAE) Batch : 0000001, 4-12-95 Purity : 20.2% Ethyl lauroyl arginate HC1 Dose : 0, 3200, 12800 and 50000 ppm Mirenat-N (equivalent to 646, 2586 and 10100 ppm Ethyl lauroyl arginate HC1) Observ.","page":23,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_001"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 34 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate","page":34,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_002"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"citation":"Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","page":36,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_003"} |
| SCCS_vision_codex | NOAEL | =93.2 | % | rat | - | - | irritation | {"citation":"Ref.: 31 3","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity","page":38,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_005"} |
| SCCS_vision_codex | NOAEL | =837 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_007"} |
| SCCS_vision_codex | NOAEL | =12 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_008"} |
| SCCS_vision_codex | NOAEL | =unclear:orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” | - | - | oral | - | reproductive toxicity | {"dose":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data.","effect":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_009"} |
| SCCS_vision_codex | NOAEL | =20.2 | % | rat | - | - | irritation | {"citation":"Ref.: 16 Mirenat-N Guideline : OECD No","dose":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females.","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, eg, adjacent to the entry of the oesophagus. The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg for males and 401 for females of Ethyl lauroyl arginate HCl/kg/day. Ref.: 16 Mirenat-N Guideline : OECD No.408 (1981) Species/strain : Rat, Crl: CD BR Group size : 10 males + 10 females per dose Active ingredient : 20.2% Ethyl lauroyl arginate HCl Test substance : Mirenat-N (21.6% of LAE) Batch : 0000001, 4-12-95 Purity : 20.2% Ethyl lauroyl arginate HC1 Dose : 0, 3200, 12800 and 50000 ppm Mirenat-N (equivalent to 646, 2586 and 10100 ppm Ethyl lauroyl arginate HC1) Observ.","page":23,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_001"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 34 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate","page":34,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_002"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"citation":"Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","page":36,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_003"} |
| SCCS_vision_codex | NOAEL | =93.2 | % | rat | - | - | irritation | {"citation":"Ref.: 31 3","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity","page":38,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_005"} |
| SCCS_vision_codex | NOAEL | =837 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_007"} |
| SCCS_vision_codex | NOAEL | =12 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_008"} |
| SCCS_vision_codex | NOAEL | =unclear:orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” | - | - | oral | - | reproductive toxicity | {"dose":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data.","effect":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_009"} |
| SCCS_vision_codex | NOAEL | =346 | mg/kg bw/day | rat | - | - | irritation | {"citation":"Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No","dose":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female.","effect":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800","page":26,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_001"} |
| SCCS_vision_codex | NOAEL | =6000 | ppm | - | oral | 28 day | repeated dose toxicity | {"citation":"Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","dose":"The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship.","effect":"on and signs of healing. The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship. In support of this, there were no treatment related effects on the bone marrow and a lack of any histopathology findings associated with the lymphoid tissues. The study authors concluded that no significant toxicological effects were observed in the animals receiving 6000 ppm or 2000 ppm LAE in the diet. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day (271 mg/kg bw/day Ethyl lauroyl arginate HCl in the males and 393 mg/kg bw/day in the females). The corresponding LOAEL was 18000 ppm equivalent to 907 mg/ kg bw/day and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","page":29,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_003"} |
| SCCS_vision_codex | NOAEL | =13 | - | rat | - | sub-chronic | repeated dose toxicity | {"dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","effect":"omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre","page":30,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | NOAEL study | {"dose":"The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","effect":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 31 induced. The high inter-individual variation seen in plasma LAE concentrations in the toxicokinetic data would suggest that similar variation could be feasible for the blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be us","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_007"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A","dose":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses:","effect":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses: There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl l","page":41,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_010"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","page":43,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_012"} |
| SCCS_vision_codex | NOAEL | =0 | - | - | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_014"} |
| SCCS_vision_codex | NOAEL | =7 | - | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage.","effect":"07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_016"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 36","dose":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls.","effect":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls. The magnitude of the difference reduced as age increased and was not accompanied by any macroscopic changes or microscopic changes in F0 and F1 adult animals so that the effect was therefore considered to be of no toxicological importance. Conclusion The study authors considered the NOAEL for reproductive performance in the Sprague Dawley CD rat to be 15000 ppm LAE, which was equivalent to at least 1073 mg/kg bw/day of LAE (946 mg/kg bw/day of Ethyl lauroyl arginate HCL) based on the lowest average intake by adult rats before pairing and up to 2600 mg/kg bw/day of LAE 92293 mg/kg bw/day of Ethyl lauroyl arginate HCL) for females during lactation. Ref.: 36","page":48,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_017"} |
| SCCS_vision_codex | NOAEL | =1.19 | mg/kg/d | rat | oral | chronic | dermal absorption | {"dose":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.","effect":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | dermal | - | dermal absorption | {"dose":"uroyl arginate of 271 mg/kg bw/day was used.","effect":"uroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_020"} |
| SCCS_vision_codex | NOAEL | =346 | mg/kg bw/day | rat | - | - | irritation | {"citation":"Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No","dose":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female.","effect":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800","page":26,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_001"} |
| SCCS_vision_codex | NOAEL | =6000 | ppm | - | oral | 28 day | repeated dose toxicity | {"citation":"Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","dose":"The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship.","effect":"on and signs of healing. The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship. In support of this, there were no treatment related effects on the bone marrow and a lack of any histopathology findings associated with the lymphoid tissues. The study authors concluded that no significant toxicological effects were observed in the animals receiving 6000 ppm or 2000 ppm LAE in the diet. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day (271 mg/kg bw/day Ethyl lauroyl arginate HCl in the males and 393 mg/kg bw/day in the females). The corresponding LOAEL was 18000 ppm equivalent to 907 mg/ kg bw/day and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","page":29,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_003"} |
| SCCS_vision_codex | NOAEL | =13 | - | rat | - | sub-chronic | repeated dose toxicity | {"dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","effect":"omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre","page":30,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | NOAEL study | {"dose":"The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","effect":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 31 induced. The high inter-individual variation seen in plasma LAE concentrations in the toxicokinetic data would suggest that similar variation could be feasible for the blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be us","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_007"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A","dose":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses:","effect":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses: There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl l","page":41,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_010"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","page":43,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_012"} |
| SCCS_vision_codex | NOAEL | =0 | - | - | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_014"} |
| SCCS_vision_codex | NOAEL | =7 | - | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage.","effect":"07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_016"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 36","dose":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls.","effect":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls. The magnitude of the difference reduced as age increased and was not accompanied by any macroscopic changes or microscopic changes in F0 and F1 adult animals so that the effect was therefore considered to be of no toxicological importance. Conclusion The study authors considered the NOAEL for reproductive performance in the Sprague Dawley CD rat to be 15000 ppm LAE, which was equivalent to at least 1073 mg/kg bw/day of LAE (946 mg/kg bw/day of Ethyl lauroyl arginate HCL) based on the lowest average intake by adult rats before pairing and up to 2600 mg/kg bw/day of LAE 92293 mg/kg bw/day of Ethyl lauroyl arginate HCL) for females during lactation. Ref.: 36","page":48,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_017"} |
| SCCS_vision_codex | NOAEL | =1.19 | mg/kg/d | rat | oral | chronic | dermal absorption | {"dose":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.","effect":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | dermal | - | dermal absorption | {"dose":"uroyl arginate of 271 mg/kg bw/day was used.","effect":"uroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_020"} |
| SCCS_vision_codex | NOAEL | =1.24 | mg/kg/d | human | inhalation | chronic | reproductive toxicity | {"dose":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applie...","effect":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_021"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | human | inhalation | chronic | repeated dose toxicity | {"dose":"0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14.","effect":"w/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation i","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_022"} |
| SCCS_vision_codex | NOAEL | =837 | - | - | oral | sub-chronic | repeated dose toxicity | {"effect":"on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_023"} |
| SCCS_vision_codex | NOAEL | =106 | mg/kg bw/day | rat | - | 90-day | NOAEL study | {"citation":"(ref 18)","dose":"Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...","effect":"pinion on ethyl lauroyl arginate as a food additive considered the non-glandular forestomach lesions were not indicative of systemic toxicity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no co","page":56,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_024"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | {"dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"-arginine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irrita","page":57,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_026"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | oral | - | NOAEL study | {"effect":"Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_030"} |
| SCCS_vision_codex | NOAEL | =28 | - | - | - | 28 day | NOAEL study | {"effect":"Unlabeled table on page 31: 28 day | LAE | Han, Wistar | M | 2120 | 3098 | 3850 | /","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_034"} |
| SCCS_vision_codex | NOAEL | =55 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_035"} |
| SCCS_vision_codex | NOAEL | =1.24 | mg/kg/d | human | inhalation | chronic | reproductive toxicity | {"dose":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applie...","effect":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_021"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | human | inhalation | chronic | repeated dose toxicity | {"dose":"0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14.","effect":"w/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation i","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_022"} |
| SCCS_vision_codex | NOAEL | =837 | - | - | oral | sub-chronic | repeated dose toxicity | {"effect":"on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_023"} |
| SCCS_vision_codex | NOAEL | =106 | mg/kg bw/day | rat | - | 90-day | NOAEL study | {"citation":"(ref 18)","dose":"Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...","effect":"pinion on ethyl lauroyl arginate as a food additive considered the non-glandular forestomach lesions were not indicative of systemic toxicity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no co","page":56,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_024"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | {"dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"-arginine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irrita","page":57,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_026"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | oral | - | NOAEL study | {"effect":"Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_030"} |
| SCCS_vision_codex | NOAEL | =28 | - | - | - | 28 day | NOAEL study | {"effect":"Unlabeled table on page 31: 28 day | LAE | Han, Wistar | M | 2120 | 3098 | 3850 | /","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_034"} |
| SCCS_vision_codex | NOAEL | =55 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_035"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | oral | chronic | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used.","effect":"SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 26 3.3.5. Safety evaluation (including calculation of the MoS) The Margin of Safety for dermal application of cosmetics was recalculated based on the new dermal absorption study and the revised exposure values for cosmetic products in the SCCS Notes of guidance, 7th revision. CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used. 0.4% preservative use only Dermal absorption of 3.0% (mean absorption of 2.1% +1 SD (0.9) was used for the calculation of the MOS. Only permitted product categories are included in this calculation and without those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products a","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"ut those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"gredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodo","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_003"} |
| SCCS_vision_codex | NOAEL | =26 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_006"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | oral | chronic | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used.","effect":"SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 26 3.3.5. Safety evaluation (including calculation of the MoS) The Margin of Safety for dermal application of cosmetics was recalculated based on the new dermal absorption study and the revised exposure values for cosmetic products in the SCCS Notes of guidance, 7th revision. CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used. 0.4% preservative use only Dermal absorption of 3.0% (mean absorption of 2.1% +1 SD (0.9) was used for the calculation of the MOS. Only permitted product categories are included in this calculation and without those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products a","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"ut those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"gredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodo","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_003"} |
| SCCS_vision_codex | NOAEL | =26 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Ch","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on W","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_003"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"SCCS/1519/13 Revision of the opinion on Ethyl lauroyl arginate HCl - submission IV (P95) ___________________________________________________________________________________________ 13 Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.0897 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Ref. 6)","dose":"6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included:","effect":"]) = 13.23 g/day C = 0.4% DAp (%) = 3% (Ref. 6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included: SED = 0.0575 + 0.02646 + 0.00574 = 0.08970 mg/kg bw/d MoS for cosmetic uses of Ethyl lauroyl arginate HCl = 3021 bw/day mg/kg 0.0897 bw/day mg/kg 271 = SCCS Comment No systemic effects are expected at all concentrations and uses requested. No correction value for the NOAEL was utilized because of the high MoS-value.","page":18,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_007"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_008"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_010"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_011"} |
| SCCS_vision_codex | NOAEL | =271 | - | - | oral | Chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Chronic | LAE | Sprague Dawley | M | 93.5 | 271 | 800 | 271","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Ch","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on W","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_003"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"SCCS/1519/13 Revision of the opinion on Ethyl lauroyl arginate HCl - submission IV (P95) ___________________________________________________________________________________________ 13 Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.0897 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Ref. 6)","dose":"6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included:","effect":"]) = 13.23 g/day C = 0.4% DAp (%) = 3% (Ref. 6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included: SED = 0.0575 + 0.02646 + 0.00574 = 0.08970 mg/kg bw/d MoS for cosmetic uses of Ethyl lauroyl arginate HCl = 3021 bw/day mg/kg 0.0897 bw/day mg/kg 271 = SCCS Comment No systemic effects are expected at all concentrations and uses requested. No correction value for the NOAEL was utilized because of the high MoS-value.","page":18,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_007"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_008"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_010"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_011"} |
| SCCS_vision_codex | NOAEL | =271 | - | - | oral | Chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Chronic | LAE | Sprague Dawley | M | 93.5 | 271 | 800 | 271","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_001"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | 28 day | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...","effect":"in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | - | Chronic | repeated dose toxicity | {"dose":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the...","effect":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_005"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutagenicity/genotoxicity Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_006"} |
| SCCS_vision_codex | NOAEL | =56 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.","effect":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.442 | mg/kg bw/day | - | oral | 9 years | NOAEL study | {"dose":"To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day.","effect":"ermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children, 3 to 9 years old’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. However, no continuo","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_009"} |
| SCCS_vision_codex | NOAEL | =95 | - | - | dermal | - | NOAEL study | {"effect":"consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of","page":20,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_013"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_016"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_001"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | 28 day | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...","effect":"in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | - | Chronic | repeated dose toxicity | {"dose":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the...","effect":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_005"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutagenicity/genotoxicity Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_006"} |
| SCCS_vision_codex | NOAEL | =56 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.","effect":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.442 | mg/kg bw/day | - | oral | 9 years | NOAEL study | {"dose":"To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day.","effect":"ermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children, 3 to 9 years old’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. However, no continuo","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_009"} |
| SCCS_vision_codex | NOAEL | =95 | - | - | dermal | - | NOAEL study | {"effect":"consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of","page":20,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_013"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_016"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_017"} |
| SCCS_vision_codex | NOAEL | =20.2 | % | rat | - | - | irritation | {"citation":"Ref.: 16 Mirenat-N Guideline : OECD No","dose":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females.","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, eg, adjacent to the entry of the oesophagus. The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg for males and 401 for females of Ethyl lauroyl arginate HCl/kg/day. Ref.: 16 Mirenat-N Guideline : OECD No.408 (1981) Species/strain : Rat, Crl: CD BR Group size : 10 males + 10 females per dose Active ingredient : 20.2% Ethyl lauroyl arginate HCl Test substance : Mirenat-N (21.6% of LAE) Batch : 0000001, 4-12-95 Purity : 20.2% Ethyl lauroyl arginate HC1 Dose : 0, 3200, 12800 and 50000 ppm Mirenat-N (equivalent to 646, 2586 and 10100 ppm Ethyl lauroyl arginate HC1) Observ.","page":23,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_001"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 34 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate","page":34,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_002"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"citation":"Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","page":36,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_003"} |
| SCCS_vision_codex | NOAEL | =93.2 | % | rat | - | - | irritation | {"citation":"Ref.: 31 3","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity","page":38,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_005"} |
| SCCS_vision_codex | NOAEL | =837 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_007"} |
| SCCS_vision_codex | NOAEL | =12 | - | rat | oral | sub-chronic | repeated dose toxicity | {"effect":"12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_008"} |
| SCCS_vision_codex | NOAEL | =unclear:orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” | - | - | oral | - | reproductive toxicity | {"dose":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data.","effect":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":40,"pdf":"sccp_o_017.pdf","row_type":"noael_study","study_id":"sccp_o_017_noael_009"} |
| SCCS_vision_codex | NOAEL | =346 | mg/kg bw/day | rat | - | - | irritation | {"citation":"Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No","dose":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female.","effect":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800","page":26,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_001"} |
| SCCS_vision_codex | NOAEL | =6000 | ppm | - | oral | 28 day | repeated dose toxicity | {"citation":"Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","dose":"The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship.","effect":"on and signs of healing. The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship. In support of this, there were no treatment related effects on the bone marrow and a lack of any histopathology findings associated with the lymphoid tissues. The study authors concluded that no significant toxicological effects were observed in the animals receiving 6000 ppm or 2000 ppm LAE in the diet. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day (271 mg/kg bw/day Ethyl lauroyl arginate HCl in the males and 393 mg/kg bw/day in the females). The corresponding LOAEL was 18000 ppm equivalent to 907 mg/ kg bw/day and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","page":29,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_003"} |
| SCCS_vision_codex | NOAEL | =13 | - | rat | - | sub-chronic | repeated dose toxicity | {"dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","effect":"omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre","page":30,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | NOAEL study | {"dose":"The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","effect":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 31 induced. The high inter-individual variation seen in plasma LAE concentrations in the toxicokinetic data would suggest that similar variation could be feasible for the blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be us","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_007"} |
| SCCS_vision_codex | NOAEL | =69.1 | % | rabbit | - | - | NOAEL study | {"citation":"Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A","dose":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses:","effect":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses: There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl l","page":41,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_010"} |
| SCCS_vision_codex | NOAEL | =173 | - | rabbit | - | - | NOAEL study | {"dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","page":43,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_012"} |
| SCCS_vision_codex | NOAEL | =0 | - | - | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_014"} |
| SCCS_vision_codex | NOAEL | =7 | - | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage.","effect":"07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan","page":45,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_016"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 36","dose":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls.","effect":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls. The magnitude of the difference reduced as age increased and was not accompanied by any macroscopic changes or microscopic changes in F0 and F1 adult animals so that the effect was therefore considered to be of no toxicological importance. Conclusion The study authors considered the NOAEL for reproductive performance in the Sprague Dawley CD rat to be 15000 ppm LAE, which was equivalent to at least 1073 mg/kg bw/day of LAE (946 mg/kg bw/day of Ethyl lauroyl arginate HCL) based on the lowest average intake by adult rats before pairing and up to 2600 mg/kg bw/day of LAE 92293 mg/kg bw/day of Ethyl lauroyl arginate HCL) for females during lactation. Ref.: 36","page":48,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_017"} |
| SCCS_vision_codex | NOAEL | =1.19 | mg/kg/d | rat | oral | chronic | dermal absorption | {"dose":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.","effect":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | dermal | - | dermal absorption | {"dose":"uroyl arginate of 271 mg/kg bw/day was used.","effect":"uroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_020"} |
| SCCS_vision_codex | NOAEL | =1.24 | mg/kg/d | human | inhalation | chronic | reproductive toxicity | {"dose":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applie...","effect":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_021"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | human | inhalation | chronic | repeated dose toxicity | {"dose":"0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14.","effect":"w/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation i","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_022"} |
| SCCS_vision_codex | NOAEL | =837 | - | - | oral | sub-chronic | repeated dose toxicity | {"effect":"on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_023"} |
| SCCS_vision_codex | NOAEL | =106 | mg/kg bw/day | rat | - | 90-day | NOAEL study | {"citation":"(ref 18)","dose":"Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...","effect":"pinion on ethyl lauroyl arginate as a food additive considered the non-glandular forestomach lesions were not indicative of systemic toxicity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no co","page":56,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_024"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | {"dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"-arginine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irrita","page":57,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_026"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | oral | - | NOAEL study | {"effect":"Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_030"} |
| SCCS_vision_codex | NOAEL | =28 | - | - | - | 28 day | NOAEL study | {"effect":"Unlabeled table on page 31: 28 day | LAE | Han, Wistar | M | 2120 | 3098 | 3850 | /","page":31,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_034"} |
| SCCS_vision_codex | NOAEL | =55 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":55,"pdf":"sccp_o_129.pdf","row_type":"noael_study","study_id":"sccp_o_129_noael_035"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | oral | chronic | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used.","effect":"SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 26 3.3.5. Safety evaluation (including calculation of the MoS) The Margin of Safety for dermal application of cosmetics was recalculated based on the new dermal absorption study and the revised exposure values for cosmetic products in the SCCS Notes of guidance, 7th revision. CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used. 0.4% preservative use only Dermal absorption of 3.0% (mean absorption of 2.1% +1 SD (0.9) was used for the calculation of the MOS. Only permitted product categories are included in this calculation and without those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products a","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/d | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"ut those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.4 | % | - | oral | - | dermal absorption | {"dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","effect":"gredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodo","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_003"} |
| SCCS_vision_codex | NOAEL | =26 | - | rat | oral | chronic | NOAEL study | {"effect":"Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":26,"pdf":"sccs_o_060.pdf","row_type":"noael_study","study_id":"sccs_o_060_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Ch","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_001"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on W","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_003"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"SCCS/1519/13 Revision of the opinion on Ethyl lauroyl arginate HCl - submission IV (P95) ___________________________________________________________________________________________ 13 Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.0897 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Ref. 6)","dose":"6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included:","effect":"]) = 13.23 g/day C = 0.4% DAp (%) = 3% (Ref. 6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included: SED = 0.0575 + 0.02646 + 0.00574 = 0.08970 mg/kg bw/d MoS for cosmetic uses of Ethyl lauroyl arginate HCl = 3021 bw/day mg/kg 0.0897 bw/day mg/kg 271 = SCCS Comment No systemic effects are expected at all concentrations and uses requested. No correction value for the NOAEL was utilized because of the high MoS-value.","page":18,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_007"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_008"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_010"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_011"} |
| SCCS_vision_codex | NOAEL | =271 | - | - | oral | Chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Chronic | LAE | Sprague Dawley | M | 93.5 | 271 | 800 | 271","page":12,"pdf":"sccs_o_138.pdf","row_type":"noael_study","study_id":"sccs_o_138_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.8 | % | - | oral | 28 day | repeated dose toxicity | {"dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_001"} |
| SCCS_vision_codex | NOAEL | =6 | - | - | oral | 28 day | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...","effect":"in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_004"} |
| SCCS_vision_codex | NOAEL | =271 | mg/kg bw/day | rat | - | Chronic | repeated dose toxicity | {"dose":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the...","effect":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_005"} |
| SCCS_vision_codex | NOAEL | =207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | {"dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","effect":"Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutagenicity/genotoxicity Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","page":13,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_006"} |
| SCCS_vision_codex | NOAEL | =56 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.","effect":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.442 | mg/kg bw/day | - | oral | 9 years | NOAEL study | {"dose":"To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day.","effect":"ermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children, 3 to 9 years old’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. However, no continuo","page":18,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_009"} |
| SCCS_vision_codex | NOAEL | =95 | - | - | dermal | - | NOAEL study | {"effect":"consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of","page":20,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_013"} |
| SCCS_vision_codex | NOAEL | =346 | - | - | oral | chronic | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_016"} |
| SCCS_vision_codex | NOAEL | =183 | - | - | oral | - | NOAEL study | {"dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"pdf":"sccs_o_166.pdf","row_type":"noael_study","study_id":"sccs_o_166_noael_017"} |
ToxValDB_ECHA_IUCLID 29 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =1000 | mg/kg bw/day | Rabbit | oral | - | reproduction developmental | GUIDELINE=EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be25f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822785_15822897_15823390:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_aee43302039af321a034266f64be2f33 |
| ToxValDB_ECHA_IUCLID | LEL | =2000 | mg/kg bw/day | Rat | oral | - | reproduction developmental | GUIDELINE=EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be25b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823386_15823505:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_4377079176b65d9163fa73abf914b4b8 |
| ToxValDB_ECHA_IUCLID | LEL | =1270 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d6f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855110_15861866:M:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7a0b6dfe17f51069cda99ffbbb01df45 |
| ToxValDB_ECHA_IUCLID | LEL | =1330 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d6f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855993_15856337_15856761_15860683:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_be32db84845f0e954343caaf5f8fe09f |
| ToxValDB_ECHA_IUCLID | LOAEL | =907 | mg/kg bw/day | Rat | oral | chronic; 52 weeks | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c980e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833683_15849612:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c45aefcea3547478a59e48a4b2e7ba19 |
| ToxValDB_ECHA_IUCLID | LOAEL | =1128 | mg/kg bw/day | Rat | oral | chronic; 52 weeks | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c980e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833684_15849611:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_935b38f1de873a26ef6d5217d5231d5f |
| ToxValDB_ECHA_IUCLID | NOAEL | =300 | mg/kg bw/day | Rabbit | oral | - | reproduction developmental | GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be255; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822785_15822897_15823390:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_37b6a9917a66b6740661f32e8ce1da29 |
| ToxValDB_ECHA_IUCLID | NOAEL | =2000 | mg/kg bw/day | Rat | oral | - | developmental | GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be262; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15824996:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_268d067021777206a88a5d04ba4e7fc9 |
| ToxValDB_ECHA_IUCLID | NOAEL | =200 | mg/kg bw/day | Rat | oral | - | reproduction developmental | GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be262; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=maternal: clinical signs|maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|mortality/survival; STUDY_GROUP=ECHA IUCLID:15824997:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_49aadd594b9ffff23118c2227a174cd3 |
| ToxValDB_ECHA_IUCLID | NOAEL | =175 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb75e4b0a7c65d226259; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833991_15849615:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ff721d7a3534c55ca90f33cb27c259b8 |
| ToxValDB_ECHA_IUCLID | NOAEL | =207 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb75e4b0a7c65d226259; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833992_15849614:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e22eed250abd233a3501576fb3f7461a |
| ToxValDB_ECHA_IUCLID | NOAEL | =50000 | ppm | Rat | oral | short-term; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c9811; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15839178:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_53084998d07ab3aedb9c34543561f639 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1139.97 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb75e4b0a7c65d22624f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15848249:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_978e5331dbc42b2acb014e9c6a69e4af |
| ToxValDB_ECHA_IUCLID | NOAEL | =1027.45 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb75e4b0a7c65d22624f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15848997:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_29af3803176878f0b0817dc7b677d105 |
| ToxValDB_ECHA_IUCLID | NOAEL | =393 | mg/kg bw/day | Rat | oral | chronic; 52 weeks | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c980e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833684_15849611:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_66c4ba017cfeac5815d06b14a9f42d23 |
| ToxValDB_ECHA_IUCLID | NOAEL | =307 | mg/kg bw/day | Rat | oral | chronic; 52 weeks | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c980e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833683_15849612:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_37713021e411a80b30f2fcb943a4e510 |
| ToxValDB_ECHA_IUCLID | NOAEL | =480 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c9814; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=stomach: body weight and weight gain|clinical signs|food consumption and compound intake|food efficiency|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|nonneoplastic histopathology|other; STUDY_GROUP=ECHA IUCLID:15849613:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a164546181aa846e19b7b891098c7b9a |
| ToxValDB_ECHA_IUCLID | NOAEL | =445 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c9814; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=stomach: body weight and weight gain|clinical signs|food consumption and compound intake|food efficiency|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|nonneoplastic histopathology|other; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833992_15849614:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_78ff9b9b4bd286bdf000d2fa35541c66 |
| ToxValDB_ECHA_IUCLID | NOAEL | =384 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c9814; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=stomach: body weight and weight gain|clinical signs|food consumption and compound intake|food efficiency|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|nonneoplastic histopathology|other; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833991_15849615:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ee7acfd1402e83ee4345ccd66a4d66f8 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1226 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855993_15856337_15856761_15860683:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cb1005f42134e10d0133af6a766c0600 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1518 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855993_15856337_15856761_15860683:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_335c39ad92399ee7d47c5fdcfc45518b |
| ToxValDB_ECHA_IUCLID | NOAEL | =1489 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15858527_15858635_15858764:F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ef4d1e5fedda5148d4a3d0323b4f3744 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1430 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=F1: test mat.; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15858527_15858635_15858764:F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_56a72024827567603104506d7196d123 |
| ToxValDB_ECHA_IUCLID | NOAEL | =2353 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15860578:F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d41c6161a8a4c288d63a6ed884f75649 |
| ToxValDB_ECHA_IUCLID | NOAEL | =2600 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855993_15856337_15856761_15860683:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_dc11a4b9d1a20eee3d7e04ca755cce3c |
| ToxValDB_ECHA_IUCLID | NOAEL | =1073 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855110_15861866:M:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c4873b7cb5ed0809508ea4ca8497ea8e |
| ToxValDB_ECHA_IUCLID | NOAEL | =1356 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d73; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15861977:M:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a605b6ceb491fd8df837a2dffd509885 |
| ToxValDB_ECHA_IUCLID | NOEL | =1000 | mg/kg bw/day | Rabbit | oral | - | developmental | GUIDELINE=EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1ece4b0a7c65d230c66; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821471_15823711:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c1908c6c108fc3a56e5bd32d46519061 |
| ToxValDB_ECHA_IUCLID | NOEL | =250 | mg/kg bw/day | Rabbit | oral | - | reproduction developmental | GUIDELINE=EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1ece4b0a7c65d230c66; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/16635?documentUUID=2ca81669-f7b1-4987-9206-6befb68e6146; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822785_15822897_15823390:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8bc07269d9ca8dfc8b913c6ed5bbcad8 |
ToxValDB_EFSA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | NOAEL | =47 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=EFSA AFC (2007). Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive. doi:10.2903/j.efsa.2007.511.; TITLE=Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive; AUTHOR=EFSA AFC; DOI=doi:10.2903/j.efsa.2007.511; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=clinical chemistry; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=EFSA:15614255:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cd437221eb9168e1c120588760bd9904 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =21.652 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15631955:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_48325fcc547c8a1777581cd3183798ea |
ToxValDB_WHO_JECFA_ADI 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_WHO_JECFA_ADI | ADI | <=4 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afda2e4b0d99f5a87eca7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/5865; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=WHO JECFA ADI:15715507:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4e5e53e526ac30e48f560ebde5579b42 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 81 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 69.1 | % | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=69.1; EFFECT=SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 34 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate; CITATION=Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69; CITATION_NUMBERS=[28,2,69]; REFERENCE=Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69","dose":"","duration":"","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 34 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Rabbit, preliminary range finding study Guideline : / Species/strain : New Zealand White rabbits female Group size : 2 non pregnant and 2 pregnant females Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate","endpoint":"","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"%","noael_value":"69.1","page":34,"route":"","species":"rabbit","study_id":"sccp_o_017_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 173 | - | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=unclear:implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A; DOSE=implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.; EFFECT=implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A; CITATION=Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A; CITATION_NUMBERS=[30,414,88,22]; REFERENCE=Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","duration":"","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","endpoint":"","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, A","page":36,"route":"","species":"rabbit","study_id":"sccp_o_017_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 69.1 | % | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=69.1; DOSE=The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain.; EFFECT=he effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate HCl Vehicle : 1% w/v aqueous methyl cellulose; CITATION=Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, Active ingredient : 69; CITATION_NUMBERS=[30,414,88,22,69]; REFERENCE=Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, Active ingredient : 69; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, Active ingredient : 69","dose":"The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain.","duration":"","effect":"he effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no-effect- level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit. Ref.: 30 Embryo-foetal toxicity Guideline : OECD Guideline 414 Species/strain : New Zealand White rabbits female Group size : 88 pregnant females, 22 per dose, Active ingredient : 69.1% Ethyl lauroyl arginate HCl Test substance : LAE Batch no : 5159 Purity : 69.1% ethyl lauroyl arginate HCl Vehicle : 1% w/v aqueous methyl cellulose","endpoint":"","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"%","noael_value":"69.1","page":36,"route":"","species":"rabbit","study_id":"sccp_o_017_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | mg/kg bw/day | - | oral | 28 day | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=271; DOSE=The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.; EFFECT=SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 31 induced. The high inter-individual variation seen in plasma LAE concentrations in the toxicokinetic data would suggest that similar variation could be feasible for the blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be us; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","duration":"28 day","effect":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 31 induced. The high inter-individual variation seen in plasma LAE concentrations in the toxicokinetic data would suggest that similar variation could be feasible for the blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be us","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":31,"route":"oral","species":"","study_id":"sccp_o_129_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 69.1 | % | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=69.1; DOSE=ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses:; EFFECT=ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses: There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl l; CITATION=Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A; CITATION_NUMBERS=[28,837,4,2]; REFERENCE=Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A","dose":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses:","duration":"","effect":"ose (mg/kg/day) 0 138 415 1382 Corpora lutea 15.6 15.5 15.7 16.0 Implantations 15.0 14.5 14.7 15.4 Resorptions 1.0 0.5 0.6 0.6 Litter responses: There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl l","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"%","noael_value":"69.1","page":41,"route":"","species":"rabbit","study_id":"sccp_o_129_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 69.1 | % | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=69.1; DOSE=(group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses.; EFFECT=There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl lauroyl arginate HCl Vehicle : 1% w/v aqueous methyl cellulose Staircase dose: Day 1 and 2: 41 mg/kg/day ethyl lauroyl arginate HCl Day 3 and 4: 83; CITATION=Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A; CITATION_NUMBERS=[28,837,4,2]; REFERENCE=Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females A","dose":"(group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses.","duration":"","effect":"There were no treatment-related effects on foetal survival as indicated by the extent of pre- and post-implantation loss and the numbers of lives foetuses. Foetal parameters: (group mean values) Dose (mg/kg/day) 0 138 415 1382 Life foetuses 14.0 14.0 14.1 14.7 Dead foetuses 0.1 0.0 0.0 0.1 Major foetal abnormalities 2/307 2/309 0/282 4/280 The no-adverse-effect level (NOAEL) for the dam was taken to be 138 mg of Ethyl lauroyl arginate HCl/kg/day concluded, because of the maternal deaths at the higher doses. The NOAEL for the foetuses was taken to be 1382 mg of Ethyl lauroyl arginate HCl/kg/day. Ref.: 28 Taken from SCCP/0837/04 Rabbit, preliminary range finding study Guideline: / Species/strain: New Zealand White rabbits female Group size: 2 non pregnant and 2 pregnant females Active ingredient: 69.1% Ethyl lauroyl arginate HCl Test substance: LAE Batch: 5159 Purity: 69.1% ethyl lauroyl arginate HCl Vehicle : 1% w/v aqueous methyl cellulose Staircase dose: Day 1 and 2: 41 mg/kg/day ethyl lauroyl arginate HCl Day 3 and 4: 83","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"%","noael_value":"69.1","page":41,"route":"","species":"rabbit","study_id":"sccp_o_129_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 173 | - | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.; DOSE=implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.; EFFECT=implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size.","duration":"","effect":"implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:implantation loss in mid-dose animals resulted in considerable differences in mean live litter size. Overall foetal weight was lowest in the high-dose group, but this was attributable to the effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","page":43,"route":"","species":"rabbit","study_id":"sccp_o_129_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 173 | - | rabbit | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:he effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.; DOSE=The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain.; EFFECT=he effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain.","duration":"","effect":"he effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:he effect of larger litter size. There was no indication that the ability of the dam to support a litter was impaired by treatment. There was a low incidence of foetal anomalies but no indication of any adverse effect of treatment. The low-dose, 173 mg Ethyl lauroyl arginate HCl/kg/day, was considered to be the no- effect-level (NOEL) for the mother, since both 346 and 691 mg Ethyl lauroyl arginate HCl/kg/day were associated with reduced food consumption and bodyweight gain. The high dose was considered to be the NOEL for the foetus. A dosage of up to 691 mg Ethyl lauroyl arginate HCl/kg/day would be suitable as the highest dosage level for a main embryo-foetal study in the rabbit.","page":43,"route":"","species":"rabbit","study_id":"sccp_o_129_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 106 | mg/kg bw/day | rat | - | 90-day | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=106; DOSE=Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...; EFFECT=pinion on ethyl lauroyl arginate as a food additive considered the non-glandular forestomach lesions were not indicative of systemic toxicity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no co; CITATION=(ref 18); CITATION_NUMBERS=[18]; REFERENCE=(ref 18); DETAILS_JSON={"cas_number":"60372-77-2","citation":"(ref 18)","dose":"Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...","duration":"90-day","effect":"pinion on ethyl lauroyl arginate as a food additive considered the non-glandular forestomach lesions were not indicative of systemic toxicity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no co","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"106","page":56,"route":"","species":"rat","study_id":"sccp_o_129_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 106 | mg/kg bw/day | rat | - | 90-day | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=106; DOSE=Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...; EFFECT=ity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no consistent pattern of white blood cells affected when different doses, time points and rat strains were compared. Comparison of the total an; CITATION=(ref 18); CITATION_NUMBERS=[18]; REFERENCE=(ref 18); DETAILS_JSON={"cas_number":"60372-77-2","citation":"(ref 18)","dose":"Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mir...","duration":"90-day","effect":"ity. However, they stated concerns that ‘effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects could not be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52-week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day.’ They considered that the NOAEL should be more in line with that seen in the 90 day Mirenat-N study (ref 18), equivalent to mean doses of 44 mg Ethyl lauroyl arginate HCl/kg body weight/day for males and 53 mg Ethyl lauroyl arginate HCl/kg body weight/day for females. The effect of Ethyl lauroyl arginate HCl on peripheral haematological parameters is equivocal, making interpretation difficult. There was no consistent pattern of white blood cells affected when different doses, time points and rat strains were compared. Comparison of the total an","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"106","page":56,"route":"","species":"rat","study_id":"sccp_o_129_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31 | - | - | oral | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.; EFFECT=Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 31: diet and the NOAEL/NOEL derived by the study authors.","page":31,"route":"oral","species":"","study_id":"sccp_o_129_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:Unlabeled table on page 31: Study | Test substance | Strain | Sex | Low dose | Mid dose | High dose | NOAEL mg/kg bw/ day; DOSE=Study | Test substance | Strain | Sex | Low dose | Mid dose | High dose | NOAEL mg/kg bw/ day; EFFECT=Unlabeled table on page 31: Study | Test substance | Strain | Sex | Low dose | Mid dose | High dose | NOAEL mg/kg bw/ day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Study | Test substance | Strain | Sex | Low dose | Mid dose | High dose | NOAEL mg/kg bw/ day","duration":"","effect":"Unlabeled table on page 31: Study | Test substance | Strain | Sex | Low dose | Mid dose | High dose | NOAEL mg/kg bw/ day","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 31: Study | Test substance | Strain | Sex | Low dose | Mid dose | High dose | NOAEL mg/kg bw/ day","page":31,"route":"","species":"","study_id":"sccp_o_129_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:Unlabeled table on page 31: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); EFFECT=Unlabeled table on page 31: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 31: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 31: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":31,"route":"","species":"","study_id":"sccp_o_129_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | mg/kg bw/day | - | - | chronic | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=271; DOSE=The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of; EFFECT=Unlabeled table on page 31: The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of","duration":"chronic","effect":"Unlabeled table on page 31: The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":31,"route":"","species":"","study_id":"sccp_o_129_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 28 | - | - | - | 28 day | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=28 day; EFFECT=Unlabeled table on page 31: 28 day | LAE | Han, Wistar | M | 2120 | 3098 | 3850 | /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"28 day","effect":"Unlabeled table on page 31: 28 day | LAE | Han, Wistar | M | 2120 | 3098 | 3850 | /","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"28 day","page":31,"route":"","species":"","study_id":"sccp_o_129_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 55 | - | rat | oral | chronic | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl; EFFECT=Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"chronic","effect":"Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 55: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":55,"route":"oral","species":"rat","study_id":"sccp_o_129_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=271; DOSE=Unlabeled table on page 55: arginate of 271 mg/kg bw/day was used.; EFFECT=Unlabeled table on page 55: arginate of 271 mg/kg bw/day was used.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Unlabeled table on page 55: arginate of 271 mg/kg bw/day was used.","duration":"","effect":"Unlabeled table on page 55: arginate of 271 mg/kg bw/day was used.","endpoint":"","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":55,"route":"","species":"","study_id":"sccp_o_129_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.4 | % | - | oral | - | - | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=0.4; EFFECT=SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 27 Margin of Safety – preservative and a.i. use NOAEL / SED = 8500 3.4. Discussion From the previous submission, the SCCP concluded that ethyl lauroyl arginate HCl was safe for the consumers when used: - up to a maximum authorised concentration of 0.4% as a preservative in cosmetic products, but excluding products for the lips, oral hygiene products and spray products - up to a maximum authorised concentration of 0.8% in soap, anti-dandruff shampoos, and non-spray deodorants. The Margin of Safety indicates that ethyl lauroyl arginate HCl has low toxicity. However; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"","effect":"SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 27 Margin of Safety – preservative and a.i. use NOAEL / SED = 8500 3.4. Discussion From the previous submission, the SCCP concluded that ethyl lauroyl arginate HCl was safe for the consumers when used: - up to a maximum authorised concentration of 0.4% as a preservative in cosmetic products, but excluding products for the lips, oral hygiene products and spray products - up to a maximum authorised concentration of 0.8% in soap, anti-dandruff shampoos, and non-spray deodorants. The Margin of Safety indicates that ethyl lauroyl arginate HCl has low toxicity. However","endpoint":"","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"%","noael_value":"0.4","page":27,"route":"oral","species":"","study_id":"sccs_o_060_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 26 | - | rat | oral | chronic | - | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=unclear:Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl; EFFECT=Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"chronic","effect":"Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","endpoint":"","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 26: The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl","page":26,"route":"oral","species":"rat","study_id":"sccs_o_060_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=271; DOSE=Unlabeled table on page 26: arginate HCl of 271 mg/kg bw/day was used.; EFFECT=Unlabeled table on page 26: arginate HCl of 271 mg/kg bw/day was used.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Unlabeled table on page 26: arginate HCl of 271 mg/kg bw/day was used.","duration":"","effect":"Unlabeled table on page 26: arginate HCl of 271 mg/kg bw/day was used.","endpoint":"","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":26,"route":"","species":"","study_id":"sccs_o_060_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.0897 | mg/kg bw/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 0.08970; DOSE=6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included:; EFFECT=]) = 13.23 g/day C = 0.4% DAp (%) = 3% (Ref. 6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included: SED = 0.0575 + 0.02646 + 0.00574 = 0.08970 mg/kg bw/d MoS for cosmetic uses of Ethyl lauroyl arginate HCl = 3021 bw/day mg/kg 0.0897 bw/day mg/kg 271 = SCCS Comment No systemic effects are expected at all concentrations and uses requested. No correction value for the NOAEL was utilized because of the high MoS-value.; CITATION=(Ref. 6); CITATION_NUMBERS=[6]; REFERENCE=(Ref. 6); DETAILS_JSON={"cas_number":"60372-77-2","citation":"(Ref. 6)","dose":"6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included:","duration":"","effect":"]) = 13.23 g/day C = 0.4% DAp (%) = 3% (Ref. 6) Typical body weight of human = 60 kg SED AxCxDApx1000/60kg = 0.02646 mg/kg bw/d (iv) SED for combined preservative and active ingredient uses when oral cosmetic products at 0.15% are included: SED = 0.0575 + 0.02646 + 0.00574 = 0.08970 mg/kg bw/d MoS for cosmetic uses of Ethyl lauroyl arginate HCl = 3021 bw/day mg/kg 0.0897 bw/day mg/kg 271 = SCCS Comment No systemic effects are expected at all concentrations and uses requested. No correction value for the NOAEL was utilized because of the high MoS-value.","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.08970","page":18,"route":"oral","species":"human","study_id":"sccs_o_138_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 6 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day; DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 6 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 346 | - | - | oral | chronic | - | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=346; DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"chronic","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"346","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 183 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=183 (NOEL); DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"183 (NOEL)","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | - | - | oral | Chronic | - | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=271; DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Chronic | LAE | Sprague Dawley | M | 93.5 | 271 | 800 | 271; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"Chronic","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Chronic | LAE | Sprague Dawley | M | 93.5 | 271 | 800 | 271","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"271","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 6 | - | - | oral | 28 day | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=unclear:in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL); DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...; EFFECT=in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...","duration":"28 day","effect":"in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"","noael_value":"unclear:in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 56 | mg/kg bw/day | rat | oral | 13-week | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=56; DOSE=e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.; EFFECT=e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.","duration":"13-week","effect":"e HCl (SCCS/1519/13) ___________________________________________________________________________________________ 18 It can be seen that in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"56","page":18,"route":"oral","species":"rat","study_id":"sccs_o_166_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | mg/kg bw/day | rat | oral | 13-week | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=271; DOSE=t in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.; EFFECT=t in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘C; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"t in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded.","duration":"13-week","effect":"t in one case (i.e. the 95th percentile exposure for children) the ADI of 0.5 mg/kg bw established by EFSA is marginally exceeded. The extremely conservative nature of this method of calculation (i.e. the simple addition of the highest estimates from food and adult cosmetic uses) should, however, be noted. SCCS comment The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘C","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":18,"route":"oral","species":"rat","study_id":"sccs_o_166_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.442 | mg/kg bw/day | - | oral | 9 years | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=0.442; DOSE=To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day.; EFFECT=ermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children, 3 to 9 years old’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. However, no continuo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day.","duration":"9 years","effect":"ermal applications were considered by the SCCP (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children, 3 to 9 years old’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added, resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. However, no continuo","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"0.442","page":18,"route":"oral","species":"","study_id":"sccs_o_166_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 56 | mg/kg bw/day | rat | oral | 13-week | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=56; DOSE=The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats.; EFFECT=yl lauroyl arginate HCl has a low systemic toxicity. However, since there is no human data concerning local toxicity for combined use of mouthwash and toothpaste at 0.15%, it can only be concluded that Ethyl lauroyl arginate HCl is safe for use in mouthwashes. The SCCS points out that the use of Ethyl lauroyl arginate HCl in oral cosmetic products appears to be for another function than preservative as parabens were present in all tested formulations. The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwas; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats.","duration":"13-week","effect":"yl lauroyl arginate HCl has a low systemic toxicity. However, since there is no human data concerning local toxicity for combined use of mouthwash and toothpaste at 0.15%, it can only be concluded that Ethyl lauroyl arginate HCl is safe for use in mouthwashes. The SCCS points out that the use of Ethyl lauroyl arginate HCl in oral cosmetic products appears to be for another function than preservative as parabens were present in all tested formulations. The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwas","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"56","page":20,"route":"oral","species":"rat","study_id":"sccs_o_166_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 271 | mg/kg bw/day | rat | oral | 13-week | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=271; DOSE=The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats.; EFFECT=f mouthwash and toothpaste at 0.15%, it can only be concluded that Ethyl lauroyl arginate HCl is safe for use in mouthwashes. The SCCS points out that the use of Ethyl lauroyl arginate HCl in oral cosmetic products appears to be for another function than preservative as parabens were present in all tested formulations. The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children’ the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats.","duration":"13-week","effect":"f mouthwash and toothpaste at 0.15%, it can only be concluded that Ethyl lauroyl arginate HCl is safe for use in mouthwashes. The SCCS points out that the use of Ethyl lauroyl arginate HCl in oral cosmetic products appears to be for another function than preservative as parabens were present in all tested formulations. The ADI of 0.5 mg/kg bw/day was established by EFSA based on a NOAEL of 47 and 56 mg/kg bw/day for males and females, respectively, from a 13-week oral toxicity study in rats. SCCP, however, used a NOAEL of 271 mg/kg bw/day in a chronic oral toxicity study in rats since the observed changes in white blood cell counts were judged to be local due to gastric mucosal lesion and therefore not relevant for cosmetic uses. However, at that time only dermal applications were considered (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children’ the","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":20,"route":"oral","species":"rat","study_id":"sccs_o_166_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.442 | mg/kg bw/day | - | oral | 3 year | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=0.442; DOSE=To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added resulting in a total exposure of 0.73 mg/kg bw/day.; EFFECT=. However, at that time only dermal applications were considered (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. The SCCS considers th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added resulting in a total exposure of 0.73 mg/kg bw/day.","duration":"3 year","effect":". However, at that time only dermal applications were considered (SCCP/1106/07). Later on, also the use as preservative up to 0.15 % Ethyl Lauroyl Arginate HCl in mouthwashes was considered safe (SCCS/1519/13). The exposure estimations provided by the applicant suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. The SCCS considers th","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"0.442","page":20,"route":"oral","species":"","study_id":"sccs_o_166_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 95 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=unclear:consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of; EFFECT=consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"","effect":"consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"","noael_value":"unclear:consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products? The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of","page":20,"route":"dermal","species":"","study_id":"sccs_o_166_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 6 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day; DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"","noael_value":"unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Study | Test substance | Strain | Sex | Low dose mg/ kg bw/ day | Mid dose mg/ kg bw/ day | High dose mg/ kg bw/ day | NOAEL mg/ kg bw/ day","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 6 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"","noael_value":"unclear:Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 346 | - | - | oral | chronic | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=346; DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"chronic","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Sub- chronic* | LAE | Han, Wistar | M | 346 | 1030 | 3346 | 346","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"","noael_value":"346","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 183 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=183 (NOEL); DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:; EFFECT=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the:","duration":"","effect":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the: Mirenat | Sprague Dawley | M | 44 | 183 | 671 | 183 (NOEL)","endpoint":"","ingredient":"codes............................................7","loael_value":"","noael_unit":"","noael_value":"183 (NOEL)","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 271 | mg/kg bw/day | rat | oral | chronic | dermal absorption | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=271; DOSE=SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 55 The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.; EFFECT=SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 55 The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 55 The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.","duration":"chronic","effect":"SCCP/1106/07 Opinion on ethyl lauroyl arginate HCl 55 The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL","endpoint":"dermal absorption","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":55,"route":"oral","species":"rat","study_id":"sccp_o_129_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =1.19 | mg/kg/d | rat | oral | chronic | dermal absorption | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 1.19; DOSE=NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.; EFFECT=NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used.","duration":"chronic","effect":"NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety","endpoint":"dermal absorption","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 1.19","page":55,"route":"oral","species":"rat","study_id":"sccp_o_129_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 0.4 | % | - | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=0.4; DOSE=uroyl arginate of 271 mg/kg bw/day was used.; EFFECT=uroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"uroyl arginate of 271 mg/kg bw/day was used.","duration":"","effect":"uroyl arginate of 271 mg/kg bw/day was used. 0.4% preservative use only A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of the cosmetic product applied daily C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission","endpoint":"dermal absorption","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"%","noael_value":"0.4","page":55,"route":"dermal","species":"","study_id":"sccp_o_129_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 271 | mg/kg bw/day | rat | oral | chronic | dermal absorption | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=271; DOSE=CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used.; EFFECT=SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 26 3.3.5. Safety evaluation (including calculation of the MoS) The Margin of Safety for dermal application of cosmetics was recalculated based on the new dermal absorption study and the revised exposure values for cosmetic products in the SCCS Notes of guidance, 7th revision. CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used. 0.4% preservative use only Dermal absorption of 3.0% (mean absorption of 2.1% +1 SD (0.9) was used for the calculation of the MOS. Only permitted product categories are included in this calculation and without those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used.","duration":"chronic","effect":"SCCS/1415/11 Opinion on ethyl lauroyl arginate HCl 26 3.3.5. Safety evaluation (including calculation of the MoS) The Margin of Safety for dermal application of cosmetics was recalculated based on the new dermal absorption study and the revised exposure values for cosmetic products in the SCCS Notes of guidance, 7th revision. CALCULATION OF THE MARGIN OF SAFETY The NOAEL derived from the chronic toxicity study (52 week, oral, rat) for ethyl lauroyl arginate HCl of 271 mg/kg bw/day was used. 0.4% preservative use only Dermal absorption of 3.0% (mean absorption of 2.1% +1 SD (0.9) was used for the calculation of the MOS. Only permitted product categories are included in this calculation and without those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products a","endpoint":"dermal absorption","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":26,"route":"oral","species":"rat","study_id":"sccs_o_060_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =271 | mg/kg bw/d | - | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 271; DOSE=Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...; EFFECT=ut those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","duration":"","effect":"ut those products with ethyl lauroyl arginate HCl as the active ingredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl","endpoint":"dermal absorption","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 271","page":26,"route":"oral","species":"","study_id":"sccs_o_060_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 0.4 | % | - | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=0.4; DOSE=Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...; EFFECT=gredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of...","duration":"","effect":"gredient at 0.8%. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg A (g/day): Amount of cosmetic products applied daily =17.4 – (1.81 [cosmetics a.i.] + 2.36 [oral care and lipstick])= 13.23 C (%): the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%): Dermal Absorption expressed as a percentage Systemic Exposure Dose SED, dermal 13.23 x 1000 x 0.4% x 3% / 60 = 0.0265 mg/kg/d NOAEL = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 10200 Combined 0.4% preservative and 0.8 % a.i. in soap, shampoo and non-spray deodorant Dermal absorption of 3.0% (highest mean absorption of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodo","endpoint":"dermal absorption","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"%","noael_value":"0.4","page":26,"route":"oral","species":"","study_id":"sccs_o_060_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =271 | mg/kg bw/d | - | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_060; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95 ADDENDUM to the SCCP Opinion on Ethyl lauroyl arginate HCl; OPINION_NUMBER=SCCS/1415/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 271; DOSE=0.11g/day TOTAL 1.81 g/day Total SED, dermal [13.23 x1000x 0.4%x 3%] + [1.81 x 1000 x 0.8% x 2.38%]/60 = 0.0322 mg/kg/d NOAEL = 271 mg/kg bw/d; EFFECT=tion of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodorants: 1.5 g/day Shampoo: 0.11g/day TOTAL 1.81 g/day Total SED, dermal [13.23 x1000x 0.4%x 3%] + [1.81 x 1000 x 0.8% x 2.38%]/60 = 0.0322 mg/kg/d NOAEL = 271 mg/kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"0.11g/day TOTAL 1.81 g/day Total SED, dermal [13.23 x1000x 0.4%x 3%] + [1.81 x 1000 x 0.8% x 2.38%]/60 = 0.0322 mg/kg/d NOAEL = 271 mg/kg bw/d","duration":"","effect":"tion of 2.1% +1x SD [0.9]) was used for the 0.4% preservative calculation. For products containing 0.8% a.i., dermal absorption of 2.38% (mean absorption of 0.82% +2 x SD [0.78]) was used. A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product containing ethyl lauryl arginate as active ingredient applied daily: Soap: 0.2 g/day Deodorants: 1.5 g/day Shampoo: 0.11g/day TOTAL 1.81 g/day Total SED, dermal [13.23 x1000x 0.4%x 3%] + [1.81 x 1000 x 0.8% x 2.38%]/60 = 0.0322 mg/kg/d NOAEL = 271 mg/kg bw/d","endpoint":"dermal absorption","ingredient":"codes .................................... 7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 271","page":26,"route":"dermal","species":"","study_id":"sccs_o_060_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 271 | mg/kg bw/day | - | oral | 28 day | genotoxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=271; DOSE=The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.; EFFECT=he blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of the Margin of Safety. 3.3.6. Mutagenicity / Genotoxicity Taken from SCCP/0837/04 Bacterial Reverse Mutation Test Study 1 Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA 1538 and E. coli WP2 uvrA/pKM101 Active ingredient: 90.1% and 90.3% Ethyl lauroyl arginate HCl Substance: LAE Batch: 3036 Purity: 93.3% Ethyl lauroyl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","duration":"28 day","effect":"he blood parameters. The table indicates the achieved doses of Ethyl lauroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of the Margin of Safety. 3.3.6. Mutagenicity / Genotoxicity Taken from SCCP/0837/04 Bacterial Reverse Mutation Test Study 1 Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA 1538 and E. coli WP2 uvrA/pKM101 Active ingredient: 90.1% and 90.3% Ethyl lauroyl arginate HCl Substance: LAE Batch: 3036 Purity: 93.3% Ethyl lauroyl","endpoint":"genotoxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":31,"route":"oral","species":"","study_id":"sccp_o_129_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 271 | mg/kg bw/day | - | oral | 28 day | genotoxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=271; DOSE=uroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.; EFFECT=uroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of the Margin of Safety. 3.3.6. Mutagenicity / Genotoxicity Taken from SCCP/0837/04 Bacterial Reverse Mutation Test Study 1 Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA 1538 and E. coli WP2 uvrA/pKM101 Active ingredient: 90.1% and 90.3% Ethyl lauroyl arginate HCl Substance: LAE Batch: 3036 Purity: 93.3% Ethyl lauroyl arginate HCl Vehicle: DMSO Concentration Test 1 range finding: 15, 50, 15; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"uroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors.","duration":"28 day","effect":"uroyl arginate HCl dose mg/kg bw /day in diet and the NOAEL/NOEL derived by the study authors. Study Test substance Strain Sex Low dose mg/kg bw/ day Mid dose mg/kg bw/ day High dose mg/kg bw/ day NOAEL mg/kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study will be used for the calculation of the Margin of Safety. 3.3.6. Mutagenicity / Genotoxicity Taken from SCCP/0837/04 Bacterial Reverse Mutation Test Study 1 Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA 1538 and E. coli WP2 uvrA/pKM101 Active ingredient: 90.1% and 90.3% Ethyl lauroyl arginate HCl Substance: LAE Batch: 3036 Purity: 93.3% Ethyl lauroyl arginate HCl Vehicle: DMSO Concentration Test 1 range finding: 15, 50, 15","endpoint":"genotoxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":31,"route":"oral","species":"","study_id":"sccp_o_129_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 20.2 | % | rat | - | - | irritation | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=20.2; DOSE=SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females.; EFFECT=SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, eg, adjacent to the entry of the oesophagus. The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg for males and 401 for females of Ethyl lauroyl arginate HCl/kg/day. Ref.: 16 Mirenat-N Guideline : OECD No.408 (1981) Species/strain : Rat, Crl: CD BR Group size : 10 males + 10 females per dose Active ingredient : 20.2% Ethyl lauroyl arginate HCl Test substance : Mirenat-N (21.6% of LAE) Batch : 0000001, 4-12-95 Purity : 20.2% Ethyl lauroyl arginate HC1 Dose : 0, 3200, 12800 and 50000 ppm Mirenat-N (equivalent to 646, 2586 and 10100 ppm Ethyl lauroyl arginate HC1) Observ.; CITATION=Ref.: 16 Mirenat-N Guideline : OECD No; CITATION_NUMBERS=[16]; REFERENCE=Ref.: 16 Mirenat-N Guideline : OECD No; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 16 Mirenat-N Guideline : OECD No","dose":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females.","duration":"","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 23 high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, eg, adjacent to the entry of the oesophagus. The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg for males and 401 for females of Ethyl lauroyl arginate HCl/kg/day. Ref.: 16 Mirenat-N Guideline : OECD No.408 (1981) Species/strain : Rat, Crl: CD BR Group size : 10 males + 10 females per dose Active ingredient : 20.2% Ethyl lauroyl arginate HCl Test substance : Mirenat-N (21.6% of LAE) Batch : 0000001, 4-12-95 Purity : 20.2% Ethyl lauroyl arginate HC1 Dose : 0, 3200, 12800 and 50000 ppm Mirenat-N (equivalent to 646, 2586 and 10100 ppm Ethyl lauroyl arginate HC1) Observ.","endpoint":"irritation","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"%","noael_value":"20.2","page":23,"route":"","species":"rat","study_id":"sccp_o_017_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 93.2 | % | rat | - | - | irritation | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=93.2; DOSE=(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...; EFFECT=erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 31 3","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","duration":"","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity","endpoint":"irritation","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"%","noael_value":"93.2","page":38,"route":"","species":"rat","study_id":"sccp_o_017_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 93.2 | % | rat | - | - | irritation | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=93.2; DOSE=g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day),...; EFFECT=g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity : 93.2% ethyl lauroyl arginate HCl 99.8% radiochemical purity Vehicle :; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 31 3","dose":"g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day),...","duration":"","effect":"g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 3.3.8.2. Teratogenicity Data in the previous section 3.3.9. Toxicokinetics In vivo and in vitro metabolism in the rat Guideline : / Species/strain : Rat, Sprague DawleyCrl:CD.BR male Group size : 6 males, in vitro 1 male liver Active ingredient : 93.2% Ethyl lauroyl arginate HCl Test substance : LAE and radio-labelled arginine LAE in all carbons of arginine Batch no : 3036 Radio-labelled NPE/LMA001/65 Purity : 93.2% ethyl lauroyl arginate HCl 99.8% radiochemical purity Vehicle :","endpoint":"irritation","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"%","noael_value":"93.2","page":38,"route":"","species":"rat","study_id":"sccp_o_017_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 346 | mg/kg bw/day | rat | - | - | irritation | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=346; DOSE=was parakeratosis, present in the majority of the high dose males and females and in one mid dose female.; EFFECT=was parakeratosis, present in the majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800; CITATION=Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No; CITATION_NUMBERS=[16,837,4]; REFERENCE=Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No","dose":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female.","duration":"","effect":"was parakeratosis, present in the majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800","endpoint":"irritation","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"346","page":26,"route":"","species":"rat","study_id":"sccp_o_129_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 346 | mg/kg bw/day | rat | - | - | irritation | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=346; DOSE=majority of the high dose males and females and in one mid dose female.; EFFECT=majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800 and 50; CITATION=Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No; CITATION_NUMBERS=[16,837,4]; REFERENCE=Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No","dose":"majority of the high dose males and females and in one mid dose female.","duration":"","effect":"majority of the high dose males and females and in one mid dose female. Ulceration was seen in 1 high dose and 1 mid dose male and two high dose females. In addition, erosions and epithelial hyperplasia were seen in all the high dose females. This was considered to indicate that the test substance had an irritant action on mucosal tissue, but that it was unusual for the changes to be restricted to such a specific area, e.g. adjacent to the entry of the oesophagus. Conclusion The No Observed Adverse Effect Level (NOAEL) was considered to be 346 mg/kg bw/day for males and 401 mg/kg bw/day for females of Ethyl lauroyl arginate HCl. Ref.: 16 Taken from SCCP/0837/04 and reassessed in this opinion Mirenat-N Guideline: OECD No.408 (1981) Species/strain: Rat, Sprague Dawley Crl: CD BR Group size: 10 males + 10 females per dose Active ingredient: 20.2% Ethyl lauroyl arginate HCl Test substance: Mirenat-N (21.6% of LAE in 73% propylene glycol) Batch: 0000001, 4-12-95 Purity: 20.2% Ethyl lauroyl arginate HCl Dose: 0, 3200, 12800 and 50","endpoint":"irritation","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"346","page":26,"route":"","species":"rat","study_id":"sccp_o_129_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 837 | - | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=unclear:SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr; EFFECT=SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"sub-chronic","effect":"SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr","endpoint":"repeated dose toxicity","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:SCCP/0837/04 Opinion on Ethyl Lauroyl Arginate (P95) 40 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main tr","page":40,"route":"oral","species":"rat","study_id":"sccp_o_017_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 12 | - | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=unclear:12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja; EFFECT=12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"sub-chronic","effect":"12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja","endpoint":"repeated dose toxicity","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The sub-chronic and chronic toxicity studies were based on Ethyl lauroyl arginate HC1, incorporated in feed. The study authors considered that in rats, the No Observed Adverse Effect Level (NOAEL) to be 346 and 401 mg Ethyl lauroyl arginate HCl/kg/day for males and females respectively. In rat studies, based on dosing by gavage. the NOAEL for the dam was taken to be 138 mg Ethyl lauroyl arginate HCl/kg/day. Mucosal irritation was indicated during both dosing procedures. Excessive salivation, frequently with staining of the fur, was noted with both dosing regimens. This suggests local irritation of the mucosa. This was more marked in females. In the sub-chronic toxicity studies in rats, the main treatment-related pathological changes with Ethyl lauroyl arginate HCl were seen in the non-glandular region of the stomach, specifically in the area adja","page":40,"route":"oral","species":"rat","study_id":"sccp_o_017_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 6000 | ppm | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=6000; DOSE=The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship.; LOAEL_VALUE=907 mg/ kg bw/day; EFFECT=on and signs of healing. The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship. In support of this, there were no treatment related effects on the bone marrow and a lack of any histopathology findings associated with the lymphoid tissues. The study authors concluded that no significant toxicological effects were observed in the animals receiving 6000 ppm or 2000 ppm LAE in the diet. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day (271 mg/kg bw/day Ethyl lauroyl arginate HCl in the males and 393 mg/kg bw/day in the females). The corresponding LOAEL was 18000 ppm equivalent to 907 mg/ kg bw/day and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M; CITATION=Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M; CITATION_NUMBERS=[33,28]; REFERENCE=Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","dose":"The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship.","duration":"28 day","effect":"on and signs of healing. The study authors considered the observed white cell disturbances were not of toxicological importance, since there was no clear dose-relationship. In support of this, there were no treatment related effects on the bone marrow and a lack of any histopathology findings associated with the lymphoid tissues. The study authors concluded that no significant toxicological effects were observed in the animals receiving 6000 ppm or 2000 ppm LAE in the diet. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day (271 mg/kg bw/day Ethyl lauroyl arginate HCl in the males and 393 mg/kg bw/day in the females). The corresponding LOAEL was 18000 ppm equivalent to 907 mg/ kg bw/day and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Ref.: 33 Comments and reassessment of the oral toxicity studies (28 day, subchronic and chronic) Hairloss was not seen in the subchronic and chronic LAE, only in the subchronic M","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"907 mg/ kg bw/day","noael_unit":"ppm","noael_value":"6000","page":29,"route":"oral","species":"","study_id":"sccp_o_129_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 13 | - | rat | - | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre; DOSE=These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.; EFFECT=omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","duration":"sub-chronic","effect":"omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:omach epithelium not to be a significant toxic effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre","page":30,"route":"","species":"rat","study_id":"sccp_o_129_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 13 | - | rat | - | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:c effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic stu; DOSE=These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.; EFFECT=c effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic stu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","duration":"sub-chronic","effect":"c effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic stu","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:c effect as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic stu","page":30,"route":"","species":"rat","study_id":"sccp_o_129_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 13 | - | rat | - | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:ct as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic study wo; DOSE=These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.; EFFECT=ct as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic study wo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat.","duration":"sub-chronic","effect":"ct as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic study wo","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:ct as they were so localised. These effects on gastric mucosa appear to be local irritation effects induced by Ethyl lauroyl arginate HCl and are unrelated to a systemic toxicity. These effects were similar to the statistically significant gastric mucosal effects seen in the high dose in the sub-chronic LAE study in the Wistar rat. No gastric mucosal effects were seen after 13 weeks in the Mirenat Sprague Dawley rat study at comparable doses to the chronic study. NOAEL Despite the different rat strains, the NOAEL/NOEL for the subchronic and chronic LAE and Mirenat studies are within the same range. Dosing in the subchronic LAE study was higher, but the histopathology seen in both the subchronic and chronic studies was similar. This could explain the lower total WBCs at week 26, as the lesions developing in the gastric mucosa would cause concomitant migration of WBC to the damaged tissue. The normal morphology of the blood cells throughout this study supports this. Individual pre-dosing haematology values in the chronic study wo","page":30,"route":"","species":"rat","study_id":"sccp_o_129_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =271 | mg/kg bw/d | human | inhalation | chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 271; DOSE=0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14.; EFFECT=w/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14.","duration":"chronic","effect":"w/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation i","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 271","page":55,"route":"inhalation","species":"human","study_id":"sccp_o_129_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 837 | - | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”; EFFECT=on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"","duration":"sub-chronic","effect":"on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:on II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that in the sub-chronic LAE study, Ethyl lauroyl arginate HCl caused mucosal irritation in the non-glandular region of the stomach. This concern was reinforced by a letter from the head of Reproductive Studies Group attached to Reference 31, commenting on the respiratory effects following gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":55,"route":"oral","species":"","study_id":"sccp_o_129_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=207; DOSE=The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.; EFFECT=-arginine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irrita; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","duration":"subchronic","effect":"-arginine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irrita","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"207","page":57,"route":"oral","species":"","study_id":"sccp_o_129_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=207; DOSE=The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.; EFFECT=ine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irritant to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","duration":"subchronic","effect":"ine were generally considerably higher than those of 13C -LAS. Thus, even assuming 100% absorption at 0.4% Ethyl lauroyl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irritant to","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"207","page":57,"route":"oral","species":"","study_id":"sccp_o_129_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=207; DOSE=The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.; EFFECT=royl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irritant to the eyes under the test conditions of the studies. It also appeared not to have sensitisation potential. Ethyl laur; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","duration":"subchronic","effect":"royl arginate HCl, it would suggest rapid hydrolysis of Ethyl lauroyl arginate HCl if absorbed through the skin. Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irritant to the eyes under the test conditions of the studies. It also appeared not to have sensitisation potential. Ethyl laur","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"207","page":57,"route":"oral","species":"","study_id":"sccp_o_129_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 207 | mg/kg bw/day | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=207; DOSE=The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.; EFFECT=Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irritant to the eyes under the test conditions of the studies. It also appeared not to have sensitisation potential. Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. The EFSA AFC; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","duration":"subchronic","effect":"Therefore, systemic exposure to Ethyl lauroyl arginate HCl and Nα-lauroyl-L-arginine in vivo is likely to be very short. If a restriction is placed on Ethyl lauroyl arginate HCl for solely dermal application in cosmetics, the local gastric mucosal effects need not be considered. The NOAEL/NOEL for Ethyl lauroyl arginate HCl in diet from the subchronic and chronic studies were within the same range. The NOAEL from the chronic study of 271 mg Ethyl lauroyl arginate HCl /kg bw/day was used for risk assessment. The NOAEL for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Ethyl lauroyl arginate HCl (up to 0.8%) was considered to be non-irritant to the eyes under the test conditions of the studies. It also appeared not to have sensitisation potential. Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. The EFSA AFC","endpoint":"repeated dose toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"207","page":57,"route":"oral","species":"","study_id":"sccp_o_129_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.8 | % | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=0.8; DOSE=Repeated dose toxicity 28 day, subchronic and chronic studies are available.; EFFECT=ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Ch; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","duration":"28 day","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Ch","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"0.8","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.8 | % | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=0.8; DOSE=Repeated dose toxicity 28 day, subchronic and chronic studies are available.; EFFECT=ion of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","duration":"28 day","effect":"ion of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"0.8","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 271 | mg/kg bw/day | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=271; DOSE=Repeated dose toxicity 28 day, subchronic and chronic studies are available.; EFFECT=0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on W; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","duration":"28 day","effect":"0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on W","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":12,"route":"oral","species":"","study_id":"sccs_o_138_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 271 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=271; DOSE=Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...; EFFECT=in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M...","duration":"28 day","effect":"in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":12,"route":"oral","species":"rat","study_id":"sccs_o_138_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 271 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=271; DOSE=doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE...; EFFECT=doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE...","duration":"28 day","effect":"doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL) M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":12,"route":"oral","species":"rat","study_id":"sccs_o_138_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.8 | % | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=0.8; DOSE=Repeated dose toxicity 28 day, subchronic and chronic studies are available.; EFFECT=ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","duration":"28 day","effect":"ermal absorption studies, the SCCS concluded that, according to the SCCS Notes of Guidance (7th revision, Ref. 7), 3.0% (mean absorption of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","endpoint":"repeated dose toxicity","ingredient":"codes............................................7","loael_value":"","noael_unit":"%","noael_value":"0.8","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.8 | % | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=0.8; DOSE=Repeated dose toxicity 28 day, subchronic and chronic studies are available.; EFFECT=ion of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","duration":"28 day","effect":"ion of 2.1% +1 SD, 0.9) is used for the calculation of the MOS as a preservative at 0.4%, and 2.38% (mean absorption of 0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","endpoint":"repeated dose toxicity","ingredient":"codes............................................7","loael_value":"","noael_unit":"%","noael_value":"0.8","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.8 | % | - | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=0.8; DOSE=Repeated dose toxicity 28 day, subchronic and chronic studies are available.; EFFECT=0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Repeated dose toxicity 28 day, subchronic and chronic studies are available.","duration":"28 day","effect":"0.82% +2 SD, 2 x 0.78, due to high variability) for use as an active ingredient at 0.8%. Repeated dose toxicity 28 day, subchronic and chronic studies are available. Table 6 indicates the achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the NO(A)EL derived by the study authors. Table 6: achieved doses of Ethyl lauroyl arginate HCl (mg/ kg bw/day) in diet and the derived NO(A)EL values Study Test substance Strain Sex Low dose mg/ kg bw/ day Mid dose mg/ kg bw/ day High dose mg/ kg bw/ day NOAEL mg/ kg bw/ day M 2120 3098 3850 LAE Han, Wistar F 2143 2999 4182 M 68 283 1070 28 day Mirenat Sprague Dawley F 71 284 1187 / M 346 1030 3346 LAE Han, Wistar F 401 1159 3527 346 M 44 183 671 Sub- chronic* Mirenat Sprague Dawley F 53 216 793 183 (NOEL)","endpoint":"repeated dose toxicity","ingredient":"codes............................................7","loael_value":"","noael_unit":"%","noael_value":"0.8","page":12,"route":"oral","species":"","study_id":"sccs_o_166_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 271 | mg/kg bw/day | rat | - | Chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=271; DOSE=SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the...; EFFECT=SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the...","duration":"Chronic","effect":"SCCS/1543/14 Revision of the Addendum to the SCCS Opinion on Ethyl lauroyl arginate HCl (SCCS/1519/13) ___________________________________________________________________________________________ 13 M 93.5 271 800 Chronic LAE Sprague Dawley F 131 393 1128 271 The NOAEL of 271 mg/kg bw/day from the chronic study is used for the calculation of the Margin of Safety. *Remark: In the previous opinion of 15 April 2008, the result section of the sub-chronic study on Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutag","endpoint":"repeated dose toxicity","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"271","page":13,"route":"","species":"rat","study_id":"sccs_o_166_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0 | - | - | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_017; REPORT_TITLE=OPINION ON ETHYL LAUROYL ARGINATE COLIPA n° P95; OPINION_NUMBER=SCCP/0837/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=unclear:orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”; DOSE=orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data.; EFFECT=orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data.","duration":"","effect":"orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","endpoint":"reproductive toxicity","ingredient":"Ethyl lauroyl arginate HCl (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:orted that the difficulties with dosing were reduced when the surface of the catheter was washed clean and used damp rather than wiped dry before dose administration but did not provide the data. Since this was a reproductive study, the histopathology of the stomach was not investigated. In reply to a letter requesting interpretation of the embryo-foetal studies, the head of Reproductive Studies Group of the Testing Laboratory stated that the effect was not a systemic toxic response. He went on to say ‘to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.”","page":40,"route":"oral","species":"","study_id":"sccp_o_017_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0 | - | - | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p; DOSE=(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...; EFFECT=erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p; CITATION=Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g; CITATION_NUMBERS=[31]; REFERENCE=Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"(group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl...","duration":"","effect":"erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p","endpoint":"reproductive toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:erse effect of treatment. Foetal parameters: (group mean values) Dose mg/kg/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the p","page":45,"route":"oral","species":"","study_id":"sccp_o_129_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0 | - | - | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It sh; DOSE=g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day),...; EFFECT=g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It sh; CITATION=Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g; CITATION_NUMBERS=[31]; REFERENCE=Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day),...","duration":"","effect":"g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It sh","endpoint":"reproductive toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:g/day 0 69 207 691 (mg/kg/day) Life foetuses 8.9 9.1 9.1 10.0 Dead foetuses 0.3 0.9 0.2 0.6 Major foetal abnormalities 3/169 4/200 3/163 2/170 Despite the slightly higher risk of irritation to the respiratory tract at concentrations of 60 mg Ethyl lauroyl arginate HCl/ml and above (dosages of 207 and 691 mg of Ethyl lauroyl arginate HCl/kg/day), it was concluded that 207 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It sh","page":45,"route":"oral","species":"","study_id":"sccp_o_129_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 7 | - | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=unclear:07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan; DOSE=31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage.; EFFECT=07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan; CITATION=Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g; CITATION_NUMBERS=[31]; REFERENCE=Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by g","dose":"31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage.","duration":"","effect":"07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan","endpoint":"reproductive toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"","noael_value":"unclear:07 mg Ethyl lauroyl arginate HCl/kg/day was the no adverse-effect level (NOAEL) for the dam and 691 mg of Ethyl lauroyl arginate HCl/kg/day was the NOAEL for the foetus. Ref.: 31 Comment Attached to this submission was a letter from the head of Reproductive Studies Group, commenting on the effect seen when Ethyl lauroyl arginate HCl was administered by gavage. He considered that the respiratory effects following gavage were due to the route of administration and not a systemic toxic response but said “to base the NOAEL on results of dietary studies should be considered in the light of the proposed route of administration for use in the material in cosmetics. It should be acceptable if the material is applied as a lotion to the body skin, but might be less acceptable if applied as a spray or to the lip/face.” From submission II Preliminary study of effects on reproductive performance Guideline: / Species/strain: Rats, Sprague-Dawley (Crl:CD®(SD)IGSBR(IGS)) Group size: F 0: 8 male, 8 female F1: 12 male, 12 female Test substan","page":45,"route":"oral","species":"rat","study_id":"sccp_o_129_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 15000 | ppm | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=15000; DOSE=5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls.; EFFECT=5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls. The magnitude of the difference reduced as age increased and was not accompanied by any macroscopic changes or microscopic changes in F0 and F1 adult animals so that the effect was therefore considered to be of no toxicological importance. Conclusion The study authors considered the NOAEL for reproductive performance in the Sprague Dawley CD rat to be 15000 ppm LAE, which was equivalent to at least 1073 mg/kg bw/day of LAE (946 mg/kg bw/day of Ethyl lauroyl arginate HCL) based on the lowest average intake by adult rats before pairing and up to 2600 mg/kg bw/day of LAE 92293 mg/kg bw/day of Ethyl lauroyl arginate HCL) for females during lactation. Ref.: 36; CITATION=Ref.: 36; CITATION_NUMBERS=[36]; REFERENCE=Ref.: 36; DETAILS_JSON={"cas_number":"60372-77-2","citation":"Ref.: 36","dose":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls.","duration":"","effect":"5000 ppm group absolute and/or bodyweight relative spleen weights of F0 and F1 females at scheduled termination and of F1 male and F1 female weanlings and F2 female weanlings on Day 30 of age were significantly lower than in controls. The magnitude of the difference reduced as age increased and was not accompanied by any macroscopic changes or microscopic changes in F0 and F1 adult animals so that the effect was therefore considered to be of no toxicological importance. Conclusion The study authors considered the NOAEL for reproductive performance in the Sprague Dawley CD rat to be 15000 ppm LAE, which was equivalent to at least 1073 mg/kg bw/day of LAE (946 mg/kg bw/day of Ethyl lauroyl arginate HCL) based on the lowest average intake by adult rats before pairing and up to 2600 mg/kg bw/day of LAE 92293 mg/kg bw/day of Ethyl lauroyl arginate HCL) for females during lactation. Ref.: 36","endpoint":"reproductive toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"ppm","noael_value":"15000","page":48,"route":"","species":"rat","study_id":"sccp_o_129_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | =1.24 | mg/kg/d | human | inhalation | chronic | reproductive toxicity | SOURCE_SUBDIR=sccp_o_129; REPORT_TITLE=OPINION ON Ethyl lauroyl arginate HCl COLIPA n° P95; OPINION_NUMBER=SCCP/1106/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 1.24; DOSE=al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applie...; EFFECT=al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applie...","duration":"chronic","effect":"al 17.79 x 1000 x 0.4% x 100% / 60 = 1.19 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative use only NOAEL / SED = 228 Combined 0.4% preservative and 0.8 % a.i .in soap, shampoo and non-spray deodorant A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 SED = 60 kg Amount of the cosmetic product as active ingredient applied daily Soap: 0.24 g/day Deodorants: 0.5 g/day Shampoo: 0.08 g/day TOTAL 0.82 g/day Total SED (16.97x 1000 x 0.4%) + (0.82 x 1000 x 0.8%) x 100%/ 60 = 1.24 mg/kg/d NOAEL (mg/kg bw/day) = 271 mg/kg bw/d Margin of Safety – preservative and a.i. use NOAEL / SED = 219 3.3.14. Discussion Submission II on Ethyl lauroyl arginate HCl included studies on acute inhalation, chronic and reproductive toxicity together with a new mutation and two toxicokinetic studies as well as two studies on human volunteers. The SCCP reassessed the data provided in Submission I, in conjunction with the new studies provided in Submission II. The earlier SCCP opinion (SCCP/0837/04) expressed concern that","endpoint":"reproductive toxicity","ingredient":"s with respect to their impact on consumer","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 1.24","page":55,"route":"inhalation","species":"human","study_id":"sccp_o_129_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | SOURCE_SUBDIR=sccs_o_138; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1519/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=207; DOSE=Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.; EFFECT=SCCS/1519/13 Revision of the opinion on Ethyl lauroyl arginate HCl - submission IV (P95) ___________________________________________________________________________________________ 13 Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","duration":"chronic","effect":"SCCS/1519/13 Revision of the opinion on Ethyl lauroyl arginate HCl - submission IV (P95) ___________________________________________________________________________________________ 13 Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"207","page":13,"route":"","species":"rat","study_id":"sccs_o_138_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 207 | mg/kg bw/day | rat | - | chronic | reproductive toxicity | SOURCE_SUBDIR=sccs_o_166; REPORT_TITLE=SCCS Opinion on; OPINION_NUMBER=SCCS/1543/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 March 2015; VALUE_TEXT=207; DOSE=Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.; EFFECT=Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutagenicity/genotoxicity Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"60372-77-2","citation":"","dose":"Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively.","duration":"chronic","effect":"Wistar Han rats states that “There was evidence of neurotoxicity during the weekly functional observational battery tests.” This is not correct and changes the interpretation of the outcome of the study. Therefore the SCCS would like to note that the sentence should be “There was no clear evidence of neurotoxicity…” Mutagenicity/genotoxicity Ethyl lauroyl arginate HCl did not appear to have any mutagenic potential under the experimental conditions. Carcinogenicity No data submitted Reproductive toxicity The NOAEL values for maternotoxicity and foetotoxicity of Ethyl lauroyl arginate HCl were 207 mg/kg bw/day and 691 mg/kg bw/day respectively. No treatment related effects were seen in a two-generation reproduction toxicity study. Toxicokinetics Low systemic toxicity of Ethyl lauroyl arginate HCl is supported by its toxicokinetics. In the chronic rat study, the rate and extent of systemic exposure to Ethyl lauroyl arginate HCl and its metabolite LAS appeared to be characterised by dose-independent kinetics. High interindiv","endpoint":"reproductive toxicity","ingredient":"codes............................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"207","page":13,"route":"","species":"rat","study_id":"sccs_o_166_noael_006"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | XPD6ZY79TB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H40N4O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"XPD6ZY79TB"} |
| openFDA substances | FDA UNII substance identifier | XPD6ZY79TB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H40N4O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"XPD6ZY79TB"} |
| openFDA substances | FDA UNII substance identifier | XPD6ZY79TB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H40N4O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"XPD6ZY79TB"} |
| openFDA substances | FDA UNII substance identifier | XPD6ZY79TB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H40N4O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"XPD6ZY79TB"} |