NOAEL Studies
Colorant
Acid Red 92 (Phloxine B) NOAEL Studies
INCI: CI 45410
CAS: 18472-87-2
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 | 10 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCNFP; Braun W.H. et al.. Acid Red 92: 13-week oral toxicity (gavage) study in Wistar Rats; RCC |
NTP_ICE_eye_irritation 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 71 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=632; Record_ID=eye_irritation_164; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=71; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090 |
| NTP_ICE_eye_irritation | EPA Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=630; Record_ID=eye_irritation_164; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090 |
| NTP_ICE_eye_irritation | GHS Classification | 2 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=631; Record_ID=eye_irritation_164; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=GHS Classification; Response=2; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090 |
| NTP_ICE_eye_irritation | Intensity | 0.74 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=628; Record_ID=eye_irritation_1300; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Vitrigel; Endpoint=Intensity; Response=0.74; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=629; Record_ID=eye_irritation_1300; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090 |
| NTP_ICE_eye_irritation | Plateau level | 82 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=627; Record_ID=eye_irritation_1300; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Vitrigel; Endpoint=Plateau level; Response=82; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090 |
SCCNFP_vision_codex 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain","page":8,"pdf":"out262_en.pdf","row_type":"noael_study","study_id":"out262_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain","page":8,"pdf":"out262_en.pdf","row_type":"noael_study","study_id":"out262_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain","page":8,"pdf":"out262_en.pdf","row_type":"noael_study","study_id":"out262_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain","page":8,"pdf":"out262_en.pdf","row_type":"noael_study","study_id":"out262_en_noael_001"} |
SCCS_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure","dose":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":15,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | - | reproductive toxicity | {"citation":"Ref.: 18","dose":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no tr...","effect":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 18","page":20,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.14 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"city / photoclastogenicity No data submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested","page":21,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure","dose":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":15,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | - | reproductive toxicity | {"citation":"Ref.: 18","dose":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no tr...","effect":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 18","page":20,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.14 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"city / photoclastogenicity No data submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested","page":21,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure","dose":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":15,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | - | reproductive toxicity | {"citation":"Ref.: 18","dose":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no tr...","effect":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 18","page":20,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.14 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"city / photoclastogenicity No data submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested","page":21,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure","dose":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","effect":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":15,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | - | reproductive toxicity | {"citation":"Ref.: 18","dose":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no tr...","effect":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 18","page":20,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.14 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"city / photoclastogenicity No data submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested","page":21,"pdf":"sccs_o_087.pdf","row_type":"noael_study","study_id":"sccs_o_087_noael_004"} |
ToxValDB_ECHA_IUCLID 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | =2000 | mg/kg bw/day | Mouse | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bc9f2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17373/7/9/3?documentUUID=5d95f378-85f2-4f18-8e15-f30ab1991803; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15824425:-:-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_66f18082c45b22a87f491b462efc9d27 |
| ToxValDB_ECHA_IUCLID | NOAEL | =250 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bcafc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17402/7/9/3?documentUUID=25c76c54-1448-448b-93ac-423023ff25f8; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15823695:M/F:-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_b7014b083a7908ee726971f9d6c625e8 |
| ToxValDB_ECHA_IUCLID | NOAEL | =50 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bcafc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17402/7/9/3?documentUUID=25c76c54-1448-448b-93ac-423023ff25f8; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: gross pathology|maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15823855: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_477b84cbbcbca4f7cbdf2f9164da0af6 |
| ToxValDB_ECHA_IUCLID | NOAEL | =2000 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bc9f2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17373/7/9/3?documentUUID=5d95f378-85f2-4f18-8e15-f30ab1991803; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15824426: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_3fc5224011a1d7844c71869a10b3c70d |
| ToxValDB_ECHA_IUCLID | NOAEL | =920 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bcb00; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17402/7/9/3?documentUUID=25c76c54-1448-448b-93ac-423023ff25f8; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15824555:M/F:-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_b52d00ca437bcb5c3b78c42d51cb4d55 |
| ToxValDB_ECHA_IUCLID | NOAEL | =500 | mg/kg bw/day | Rat | oral | short-term; 14 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbfee4b0a7c65d228660; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/19796/7/6/2?documentUUID=cd2173fe-e97a-4c02-a634-cb93088728c5; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15848690_15849229: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_e22083a21a8ea03c20ab5167dca3f4db |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =10 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604110_15604111:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8ba6c4e6baf95db1ae82cf55a6d5162a |
| ToxValDB_ECOTOX | NOEL | =1 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604110_15604111:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=041bc63ebdccaeedafd5259c08c6159e |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =15.1 | 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:15635085:-:--; 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_7a17b86f6fe3dae23b0c63972f56d950 |
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 50 | mg/kg bw/day | - | - | - | developmental toxicity | SOURCE_SUBDIR=out262_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 92 COLIPA n° C53; OPINION_NUMBER=SCCNFP/0788/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=Teratogenicity Acid Red 92 elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested.; EFFECT=er, the assessment of skin irritation with colorants as test substances is always difficult due to the staining of the test sites and thus masking of possible erythema. Sensitisation Acid Red 92 is not a skin sensitizer under experimental conditions stricter than use conditions. Therefore, Acid Red 92 does not pose a sensitizing risk to consumers when used as intended. Teratogenicity Acid Red 92 elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Percutaneous absorption Three in vitro percutaneous absorption studies were submitted (ref. 9-11). In all 3 studies:; CITATION=(ref. 9-11); CITATION_NUMBERS=[9,11]; REFERENCE=(ref. 9-11); DETAILS_JSON={"cas_number":"18472-87-2","citation":"(ref. 9-11)","dose":"Teratogenicity Acid Red 92 elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested.","duration":"","effect":"er, the assessment of skin irritation with colorants as test substances is always difficult due to the staining of the test sites and thus masking of possible erythema. Sensitisation Acid Red 92 is not a skin sensitizer under experimental conditions stricter than use conditions. Therefore, Acid Red 92 does not pose a sensitizing risk to consumers when used as intended. Teratogenicity Acid Red 92 elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Percutaneous absorption Three in vitro percutaneous absorption studies were submitted (ref. 9-11). In all 3 studies:","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":17,"route":"","species":"","study_id":"out262_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 50 | mg/kg bw/day | human | - | - | irritation | SOURCE_SUBDIR=out262_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 92 COLIPA n° C53; OPINION_NUMBER=SCCNFP/0788/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=Toxicity The NOAEL for systemic toxicity was set at 50 mg/kg bw/day, assuming that the signs of stomach irritation in the mid-dose group represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors.; EFFECT=creased among the dosed males. The authors do not comment on the pituitary tumours, and no data was given concerning variation in historical controls. Ref.: A Human studies No data. 2.10. Special investigations No data. 2.11. Safety evaluation Not applicable 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity, impurities and physical constants (see general comments in the end of section 2.2.10.). Toxicity The NOAEL for systemic toxicity was set at 50 mg/kg bw/day, assuming that the signs of stomach irritation in the mid-dose group represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors. Irritation & corrosivity Acid Red 92 is neither considered a skin or eye irritant. However, the assessment of skin irritation with colorants as test substances is always difficult due to the staining of the test sites and thus masking of possible erythema. Sensi; CITATION=Ref.: A Human studies No data; CITATION_NUMBERS=[]; REFERENCE=Ref.: A Human studies No data; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: A Human studies No data","dose":"Toxicity The NOAEL for systemic toxicity was set at 50 mg/kg bw/day, assuming that the signs of stomach irritation in the mid-dose group represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors.","duration":"","effect":"creased among the dosed males. The authors do not comment on the pituitary tumours, and no data was given concerning variation in historical controls. Ref.: A Human studies No data. 2.10. Special investigations No data. 2.11. Safety evaluation Not applicable 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity, impurities and physical constants (see general comments in the end of section 2.2.10.). Toxicity The NOAEL for systemic toxicity was set at 50 mg/kg bw/day, assuming that the signs of stomach irritation in the mid-dose group represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors. Irritation & corrosivity Acid Red 92 is neither considered a skin or eye irritant. However, the assessment of skin irritation with colorants as test substances is always difficult due to the staining of the test sites and thus masking of possible erythema. Sensi","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":17,"route":"","species":"human","study_id":"out262_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out262_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 92 COLIPA n° C53; OPINION_NUMBER=SCCNFP/0788/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).; EFFECT=ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain; CITATION=Ref.: 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref.: 3 2; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: 3 2","dose":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","duration":"Sub-chronic","effect":"ration of various segments of the digestive tract in all groups Pathology : stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":8,"route":"dermal","species":"","study_id":"out262_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out262_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 92 COLIPA n° C53; OPINION_NUMBER=SCCNFP/0788/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males.; EFFECT=squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain : New Zealand albino white rabbit Group size : 3 animals (1 male, 2 females) Observ. Period : 14 days Test substance : Acid Red 92, moistened with 0.1ml of water Purity : 94.0 - 99.5% Batch no : AR92-020420 Dose level : 0; CITATION=Ref.: 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref.: 3 2; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: 3 2","dose":"In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males.","duration":"Sub-chronic","effect":"squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Remark Assuming that in the mid-dose group the signs of stomach irritation represent a local effect due to irritating potential of the test substance, and assuming that the mortalities were due to dosing errors, the NOAEL for systemic toxicity could be placed at 50 mg/kg bw/day. Ref.: 3 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992) Species/strain : New Zealand albino white rabbit Group size : 3 animals (1 male, 2 females) Observ. Period : 14 days Test substance : Acid Red 92, moistened with 0.1ml of water Purity : 94.0 - 99.5% Batch no : AR92-020420 Dose level : 0","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":8,"route":"dermal","species":"rabbit","study_id":"out262_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | 50 | mg/kg bw/day | pig | - | - | reproductive toxicity | SOURCE_SUBDIR=out262_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 92 COLIPA n° C53; OPINION_NUMBER=SCCNFP/0788/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=at 250 mg/kg bw/day Food intake : transient slight reductions at 250 mg/kg bw/day Reproductive data : no treatment related effects Necropsy F0 : reddish stomach/ intestinal content in mid- and high-dose group General foetal data : no treatment related effects Foetal visceral exam. : no treatment related effects Foetal skeletal exam. : no treatme...; EFFECT=at 250 mg/kg bw/day Food intake : transient slight reductions at 250 mg/kg bw/day Reproductive data : no treatment related effects Necropsy F0 : reddish stomach/ intestinal content in mid- and high-dose group General foetal data : no treatment related effects Foetal visceral exam. : no treatment related effects Foetal skeletal exam. : no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryo- toxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 8 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption, study 1 Guideline : / Test system : Split thickness pig skin (1000 µm), 5 samples. No justification for the use of 1000 µm (= full thickness) skin is given Contact time : 30 minutes Test substance : Acid Red 92 (WR802177), used at 1.67% (final) in a an oxidative formulation (code 8190568C, composition not stated) Control : composition not stated Purity : 94.0; CITATION=Ref.: 8 2; CITATION_NUMBERS=[8,2]; REFERENCE=Ref.: 8 2; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: 8 2","dose":"at 250 mg/kg bw/day Food intake : transient slight reductions at 250 mg/kg bw/day Reproductive data : no treatment related effects Necropsy F0 : reddish stomach/ intestinal content in mid- and high-dose group General foetal data : no treatment related effects Foetal visceral exam. : no treatment related effects Foetal skeletal exam. : no treatme...","duration":"","effect":"at 250 mg/kg bw/day Food intake : transient slight reductions at 250 mg/kg bw/day Reproductive data : no treatment related effects Necropsy F0 : reddish stomach/ intestinal content in mid- and high-dose group General foetal data : no treatment related effects Foetal visceral exam. : no treatment related effects Foetal skeletal exam. : no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryo- toxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 8 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption, study 1 Guideline : / Test system : Split thickness pig skin (1000 µm), 5 samples. No justification for the use of 1000 µm (= full thickness) skin is given Contact time : 30 minutes Test substance : Acid Red 92 (WR802177), used at 1.67% (final) in a an oxidative formulation (code 8190568C, composition not stated) Control : composition not stated Purity : 94.0","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":12,"route":"","species":"pig","study_id":"out262_en_noael_003"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 50 | mg/kg bw/d | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).; EFFECT=roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION=Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure; CITATION_NUMBERS=[12,50]; REFERENCE=Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure","dose":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females).","duration":"Chronic","effect":"roscopy: passive discolouration of various segments of the digestive tract in all groups Pathology: stomach irritation in both sexes at 250 mg/kg bw/day (vacuolation limiting ridge epithelium, hyaline inclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"genotoxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":15,"route":"","species":"","study_id":"sccs_o_087_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 50 | mg/kg bw/d | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males.; EFFECT=nclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION=Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure; CITATION_NUMBERS=[12,50]; REFERENCE=Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure","dose":"In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males.","duration":"Chronic","effect":"nclusions in glandular mucosa and squamous hyperplasia in most males and females, and submucosal cell infiltrate in all females). In males of the 50 mg/kg bw/day group slight stomach irritation was observed (squamous hyperplasia) in a number of males. Conclusion 10 mg/kg bw/day was established by the authors as the NOAEL. Ref.: 12 Comment of the SCCS At 50 mg/kg bw/d, only stomach irritation was observed but the SCCS considers this effect as not relevant for skin exposure. The SCCS considers 50 mg/kg bw/d as the NOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"genotoxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":15,"route":"","species":"","study_id":"sccs_o_087_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.14 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT== 0.14; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...; EFFECT=city / photoclastogenicity No data submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"18472-87-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","duration":"sub-chronic","effect":"city / photoclastogenicity No data submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested","endpoint":"repeated dose toxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 0.14","page":21,"route":"oral","species":"rat","study_id":"sccs_o_087_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =50 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...; EFFECT=ta submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested in typ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"18472-87-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","duration":"sub-chronic","effect":"ta submitted 3.3.11. Human data 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 Acid Red 92 Oxidative conditions (Worst case) Absorption through the skin A = 14.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.14 mg/kg bw/day No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/day (sub-chronic, maternal and developmental toxicity, oral, rat) Adjusted for oral bioavailability 50% bioavailability* = 25 mg/kg bw/day MOS = 178 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties Identity, purity and stability of the test substance used for toxicity testing have been investigated according to the state of the art. Stability has not been tested in typ","endpoint":"repeated dose toxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 50","page":21,"route":"oral","species":"rat","study_id":"sccs_o_087_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw/day | rabbit | dermal | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=Dermal absorption The dose applied (100 mg/cm2) was too high.; EFFECT=the conditions of this experiment, Acid Red 92 was irritating to the rabbit eye. Acid Red 92 is not a skin sensitizer under the defined experimental conditions. Dermal absorption The dose applied (100 mg/cm2) was too high. The mean + 2SD should be used in calculating the MOS. Under non-oxidative conditions, this is 4.99 + 2 x 0.779 = 6.548 μg/cm2; under oxidative conditions, it is 8.18 + 2 x 3.20 = 14.58 μg/cm2. General toxicity No data on acute toxicity were provided. The SCCS considers 50 mg/kg bw/day as the NOAEL for sub-chronic toxicity. In the developmental toxicity study, the NOAEL for maternal toxicity was 50 mg/kg bw/day. There was no embryotoxicity or teratogenicity at the highest dose tested (150 mg/kg bw/day). No further data on reproductive toxicity were provided. Mutagenicity Overall, the genotoxicity of Acid Red 92 is investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. The induction of gene mutations was studied in in vitro tests.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"18472-87-2","citation":"","dose":"Dermal absorption The dose applied (100 mg/cm2) was too high.","duration":"sub-chronic","effect":"the conditions of this experiment, Acid Red 92 was irritating to the rabbit eye. Acid Red 92 is not a skin sensitizer under the defined experimental conditions. Dermal absorption The dose applied (100 mg/cm2) was too high. The mean + 2SD should be used in calculating the MOS. Under non-oxidative conditions, this is 4.99 + 2 x 0.779 = 6.548 μg/cm2; under oxidative conditions, it is 8.18 + 2 x 3.20 = 14.58 μg/cm2. General toxicity No data on acute toxicity were provided. The SCCS considers 50 mg/kg bw/day as the NOAEL for sub-chronic toxicity. In the developmental toxicity study, the NOAEL for maternal toxicity was 50 mg/kg bw/day. There was no embryotoxicity or teratogenicity at the highest dose tested (150 mg/kg bw/day). No further data on reproductive toxicity were provided. Mutagenicity Overall, the genotoxicity of Acid Red 92 is investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. The induction of gene mutations was studied in in vitro tests.","endpoint":"repeated dose toxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":22,"route":"dermal","species":"rabbit","study_id":"sccs_o_087_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw/day | - | dermal | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=Dermal absorption The dose applied (100 mg/cm2) was too high.; EFFECT=it eye. Acid Red 92 is not a skin sensitizer under the defined experimental conditions. Dermal absorption The dose applied (100 mg/cm2) was too high. The mean + 2SD should be used in calculating the MOS. Under non-oxidative conditions, this is 4.99 + 2 x 0.779 = 6.548 μg/cm2; under oxidative conditions, it is 8.18 + 2 x 3.20 = 14.58 μg/cm2. General toxicity No data on acute toxicity were provided. The SCCS considers 50 mg/kg bw/day as the NOAEL for sub-chronic toxicity. In the developmental toxicity study, the NOAEL for maternal toxicity was 50 mg/kg bw/day. There was no embryotoxicity or teratogenicity at the highest dose tested (150 mg/kg bw/day). No further data on reproductive toxicity were provided. Mutagenicity Overall, the genotoxicity of Acid Red 92 is investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. The induction of gene mutations was studied in in vitro tests. Acid Red 92 did not induce gene mutations in bacteria nor in cultured ma; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"18472-87-2","citation":"","dose":"Dermal absorption The dose applied (100 mg/cm2) was too high.","duration":"sub-chronic","effect":"it eye. Acid Red 92 is not a skin sensitizer under the defined experimental conditions. Dermal absorption The dose applied (100 mg/cm2) was too high. The mean + 2SD should be used in calculating the MOS. Under non-oxidative conditions, this is 4.99 + 2 x 0.779 = 6.548 μg/cm2; under oxidative conditions, it is 8.18 + 2 x 3.20 = 14.58 μg/cm2. General toxicity No data on acute toxicity were provided. The SCCS considers 50 mg/kg bw/day as the NOAEL for sub-chronic toxicity. In the developmental toxicity study, the NOAEL for maternal toxicity was 50 mg/kg bw/day. There was no embryotoxicity or teratogenicity at the highest dose tested (150 mg/kg bw/day). No further data on reproductive toxicity were provided. Mutagenicity Overall, the genotoxicity of Acid Red 92 is investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. The induction of gene mutations was studied in in vitro tests. Acid Red 92 did not induce gene mutations in bacteria nor in cultured ma","endpoint":"repeated dose toxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":22,"route":"dermal","species":"","study_id":"sccs_o_087_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 50 | mg/kg bw/day | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_087; REPORT_TITLE=OPINION ON Acid Red 92 COLIPA n° C53; OPINION_NUMBER=SCCS/1428/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no tr...; EFFECT=reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 18; CITATION=Ref.: 18; CITATION_NUMBERS=[18]; REFERENCE=Ref.: 18; DETAILS_JSON={"cas_number":"18472-87-2","citation":"Ref.: 18","dose":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no tr...","duration":"","effect":"reductions at 250 mg/kg bw/day Food intake: transient slight reductions at 250 mg/kg bw/day Reproductive data: no treatment related effects Necropsy F0: reddish stomach/ intestinal content in mid- and high-dose group General foetal data: no treatment related effects Foetal visceral exam.: no treatment related effects Foetal skeletal exam.: no treatment related effects Conclusion The test substance elicited slight maternal toxicity at 250 mg/kg bw/day but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 50 mg/kg bw/day. Ref.: 18","endpoint":"reproductive toxicity","ingredient":"Fluorescein, 2',4',5',7'-tetrabromo","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":20,"route":"","species":"","study_id":"sccs_o_087_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 767IP0Y5NH | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H2Br4Cl4O5.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"767IP0Y5NH"} |
| openFDA substances | FDA UNII substance identifier | 767IP0Y5NH | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H2Br4Cl4O5.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"767IP0Y5NH"} |
| openFDA substances | FDA UNII substance identifier | 767IP0Y5NH | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H2Br4Cl4O5.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"767IP0Y5NH"} |
| openFDA substances | FDA UNII substance identifier | 767IP0Y5NH | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H2Br4Cl4O5.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"767IP0Y5NH"} |