NOAEL Studies
Cosmetic Ingredient
Silica NOAEL Studies
INCI: SILICA
CAS: 7631-86-9
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | NOAEL | 100 | mg/kg bw/day | rat | oral | 730 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | rat | oral | 180 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 800 | mg/kg bw/day | dog | oral | 28 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1000 | mg/kg bw/day | rat | oral | 56 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1340 | mg/kg bw/day | mouse | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1350 | mg/kg bw/day | rat | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1600 | mg/kg bw/day | rabbit | oral | 13 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 5000 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
IARC Monographs 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1996 | IARC Monographs | {"additional_info":"volume_publication_year=1997","evaluation_year":1996,"source_table":"iarc_classifications","volume":"Sup 7, 68"} |
NTP_ICE_acute_inhalation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >5.01 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1099; Record_ID=acute_inhalation_2961; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1029677; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=5.01; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/3/3/?documentUUID=4ce431bb-8e7c-46af-a818-2e5ab5479145; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1029677 |
NTP_ICE_cancer 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_cancer | IARC group | 3 | unitless | - | - | - | WOE; IARC Carcinogenicity | sheet=Data; excel_row=2066; Record_ID=cancer_3858; Data_Type=WOE; Formulation_Name=Silica; Mixture=Chemical; DTXSID=DTXSID1029677; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/139; http://publications.iarc.fr/86; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1029677 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=14308; RecordID=ARPathway2016_1537; DatasetName=ARPathway2016; DTXSID=DTXSID1029677; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1029677 |
NTP_ICE_eye_irritation 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 2.7 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=621; Record_ID=eye_irritation_167; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1029677; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=2.7; 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/DTXSID1029677 |
| NTP_ICE_eye_irritation | Intensity | 0.05 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=626; Record_ID=eye_irritation_1229; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1029677; Assay=Vitrigel; Endpoint=Intensity; Response=0.05; 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/DTXSID1029677 |
| NTP_ICE_eye_irritation | Lag time | >180 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=625; Record_ID=eye_irritation_1229; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1029677; Assay=Vitrigel; Endpoint=Lag time; Response_Modifier=>; Response=180; 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/DTXSID1029677 |
| NTP_ICE_eye_irritation | Plateau level | 0 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=624; Record_ID=eye_irritation_1229; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1029677; Assay=Vitrigel; Endpoint=Plateau level; Response=0; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1029677 |
SCCS_vision_codex 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =4 | - | - | - | - | NOAEL study | {"effect":"xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi","page":59,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_010"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | - | - | NOAEL study | {"effect":"xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi","page":59,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_010"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | - | - | NOAEL study | {"effect":"xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi","page":59,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_010"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | - | - | NOAEL study | {"effect":"xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi","page":59,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_010"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | 90 days | NOAEL study | {"citation":"Ref.: Pr-A (1958) in OECD (2004) Relevant Open","effect":"igns of toxicity, and body weight changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open","page":32,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | 90 days | NOAEL study | {"citation":"Ref.: Pr-A (1958) in OECD (2004) Relevant Open","effect":"igns of toxicity, and body weight changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open","page":32,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | 90 days | NOAEL study | {"citation":"Ref.: Pr-A (1958) in OECD (2004) Relevant Open","effect":"igns of toxicity, and body weight changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open","page":32,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | 90 days | NOAEL study | {"citation":"Ref.: Pr-A (1958) in OECD (2004) Relevant Open","effect":"igns of toxicity, and body weight changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open","page":32,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_003"} |
| SCCS_vision_codex | NOAEL | =6.7 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day.","effect":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn fr","page":31,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_001"} |
| SCCS_vision_codex | NOAEL | =6.7 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day.","effect":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn fr","page":31,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_001"} |
| SCCS_vision_codex | NOAEL | =6.7 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day.","effect":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn fr","page":31,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_001"} |
| SCCS_vision_codex | NOAEL | =6.7 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day.","effect":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn fr","page":31,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg | - | - | 3-week | NOAEL study | {"dose":"At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.","effect":"in organ weight and no macroscopic findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.","page":33,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_005"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 4-week | reproductive toxicity | {"dose":"Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item.","effect":"on litter size, pup weight at birth and pup appearance and behaviour. Pup development over the 4-week lactation period was not affected by administration of Py-SAS-NA-2, and no salient macroscopic findings were noted in pups at the end of the study. Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item. Accordingly, under the conditions of the present study, the No Observed Effect Level (NOEL) was above 500 mg/kg/day for male and female reproductive performance as well as pre- natal and post-natal development. SCCS comment Information on material characterisation for Py-SAS-NA-2 batch 31520315221 dates from 2013 and was provided to the SCCS. The toxicological study however was performed in 1965 and no information on the batch of Py-SAS-NA-2 used in the toxicity study is given. Thus, it is not clear, whether the material used for the reproductive toxicity study 4 decades ago exhibits the same physico-c","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg | - | - | 3-week | NOAEL study | {"dose":"At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.","effect":"in organ weight and no macroscopic findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.","page":33,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_005"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 4-week | reproductive toxicity | {"dose":"Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item.","effect":"on litter size, pup weight at birth and pup appearance and behaviour. Pup development over the 4-week lactation period was not affected by administration of Py-SAS-NA-2, and no salient macroscopic findings were noted in pups at the end of the study. Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item. Accordingly, under the conditions of the present study, the No Observed Effect Level (NOEL) was above 500 mg/kg/day for male and female reproductive performance as well as pre- natal and post-natal development. SCCS comment Information on material characterisation for Py-SAS-NA-2 batch 31520315221 dates from 2013 and was provided to the SCCS. The toxicological study however was performed in 1965 and no information on the batch of Py-SAS-NA-2 used in the toxicity study is given. Thus, it is not clear, whether the material used for the reproductive toxicity study 4 decades ago exhibits the same physico-c","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg | - | - | 3-week | NOAEL study | {"dose":"At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.","effect":"in organ weight and no macroscopic findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.","page":33,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_005"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 4-week | reproductive toxicity | {"dose":"Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item.","effect":"on litter size, pup weight at birth and pup appearance and behaviour. Pup development over the 4-week lactation period was not affected by administration of Py-SAS-NA-2, and no salient macroscopic findings were noted in pups at the end of the study. Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item. Accordingly, under the conditions of the present study, the No Observed Effect Level (NOEL) was above 500 mg/kg/day for male and female reproductive performance as well as pre- natal and post-natal development. SCCS comment Information on material characterisation for Py-SAS-NA-2 batch 31520315221 dates from 2013 and was provided to the SCCS. The toxicological study however was performed in 1965 and no information on the batch of Py-SAS-NA-2 used in the toxicity study is given. Thus, it is not clear, whether the material used for the reproductive toxicity study 4 decades ago exhibits the same physico-c","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg | - | - | 3-week | NOAEL study | {"dose":"At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.","effect":"in organ weight and no macroscopic findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.","page":33,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_005"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 4-week | reproductive toxicity | {"dose":"Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item.","effect":"on litter size, pup weight at birth and pup appearance and behaviour. Pup development over the 4-week lactation period was not affected by administration of Py-SAS-NA-2, and no salient macroscopic findings were noted in pups at the end of the study. Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item. Accordingly, under the conditions of the present study, the No Observed Effect Level (NOEL) was above 500 mg/kg/day for male and female reproductive performance as well as pre- natal and post-natal development. SCCS comment Information on material characterisation for Py-SAS-NA-2 batch 31520315221 dates from 2013 and was provided to the SCCS. The toxicological study however was performed in 1965 and no information on the batch of Py-SAS-NA-2 used in the toxicity study is given. Thus, it is not clear, whether the material used for the reproductive toxicity study 4 decades ago exhibits the same physico-c","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_007"} |
| SCCS_vision_codex | NOAEL | =1340 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"citation":"Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al","dose":"(1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15).","effect":"icant’s conclusion, the study cannot be considered as adequate. Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al. (1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15). The administration of SAS-G-1 did not affect foetal survival and produced no changes in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both matern","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_008"} |
| SCCS_vision_codex | NOAEL | =1340 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"citation":"Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al","dose":"(1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15).","effect":"icant’s conclusion, the study cannot be considered as adequate. Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al. (1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15). The administration of SAS-G-1 did not affect foetal survival and produced no changes in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both matern","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_008"} |
| SCCS_vision_codex | NOAEL | =1340 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"citation":"Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al","dose":"(1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15).","effect":"icant’s conclusion, the study cannot be considered as adequate. Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al. (1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15). The administration of SAS-G-1 did not affect foetal survival and produced no changes in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both matern","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_008"} |
| SCCS_vision_codex | NOAEL | =1340 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"citation":"Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al","dose":"(1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15).","effect":"icant’s conclusion, the study cannot be considered as adequate. Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al. (1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15). The administration of SAS-G-1 did not affect foetal survival and produced no changes in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both matern","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_008"} |
| SCCS_vision_codex | NOAEL | =1350 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"dose":"The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973).","effect":"es in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both maternal and developmental toxicity was above 1350 mg/kg/day (US-FDA, 1973). Finally, the absence of maternal and developmental toxicity potential of SAS-G-1 was confirmed in two studies conducted in rabbits and hamsters. SAS-G-1 was administered at the dose levels 0, 16, 74.3, 345, and 1600 mg/kg/day by gavage to pregnant rabbits and hamsters during the sensitive period of organogenesis. The test material had no toxic potential in dams and conceptuses, and specifically no teratogenic potential. The NOEL","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_009"} |
| SCCS_vision_codex | NOAEL | =1350 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"dose":"The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973).","effect":"es in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both maternal and developmental toxicity was above 1350 mg/kg/day (US-FDA, 1973). Finally, the absence of maternal and developmental toxicity potential of SAS-G-1 was confirmed in two studies conducted in rabbits and hamsters. SAS-G-1 was administered at the dose levels 0, 16, 74.3, 345, and 1600 mg/kg/day by gavage to pregnant rabbits and hamsters during the sensitive period of organogenesis. The test material had no toxic potential in dams and conceptuses, and specifically no teratogenic potential. The NOEL","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_009"} |
| SCCS_vision_codex | NOAEL | =1350 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"dose":"The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973).","effect":"es in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both maternal and developmental toxicity was above 1350 mg/kg/day (US-FDA, 1973). Finally, the absence of maternal and developmental toxicity potential of SAS-G-1 was confirmed in two studies conducted in rabbits and hamsters. SAS-G-1 was administered at the dose levels 0, 16, 74.3, 345, and 1600 mg/kg/day by gavage to pregnant rabbits and hamsters during the sensitive period of organogenesis. The test material had no toxic potential in dams and conceptuses, and specifically no teratogenic potential. The NOEL","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_009"} |
| SCCS_vision_codex | NOAEL | =1350 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"dose":"The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973).","effect":"es in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both maternal and developmental toxicity was above 1350 mg/kg/day (US-FDA, 1973). Finally, the absence of maternal and developmental toxicity potential of SAS-G-1 was confirmed in two studies conducted in rabbits and hamsters. SAS-G-1 was administered at the dose levels 0, 16, 74.3, 345, and 1600 mg/kg/day by gavage to pregnant rabbits and hamsters during the sensitive period of organogenesis. The test material had no toxic potential in dams and conceptuses, and specifically no teratogenic potential. The NOEL","page":52,"pdf":"sccs_o_175.pdf","row_type":"noael_study","study_id":"sccs_o_175_noael_009"} |
ToxValDB_Cal_OEHHA_REL_derivations 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_Cal_OEHHA_REL_derivations | BMCL (01) | =2.12 | (mg/m3 )-yr CDE | Human | inhalation | chronic; 24 years | occupational | LONG_REF=Hnizdo E, Sluis-Cremer GK. 1993. Risk of silicosis in a cohort of white South African gold miners. Am J Ind Med. 24(4):447-57.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c97043e4b02565fc7d32ce; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://oehha.ca.gov/; SUBSOURCE_URL=https://oehha.ca.gov/sites/default/files/media/downloads/crnr/appendixd3final.pdf; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=Silicosis; STUDY_GROUP=Cal OEHHA REL derivations:15952141:-:-white South African gold miners; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8ec28a21819b56a6f69a54aaa9e59e96 |
ToxValDB_ECHA_IUCLID 62 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEC | =10 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827865_15827866_15827867_15829312: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_c7d5f171d19c9526fc2db9e7c0ca62d9 |
| ToxValDB_ECHA_IUCLID | LOAEC | =2.5 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827924_15827925_15827926_15828605_15828606_15828607: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_e3b025c7ffcb14e1232cd9f46a1030c9 |
| ToxValDB_ECHA_IUCLID | LOAEC | =50.4 | mg/m3 | Rat | inhalation | short-term; 4 weeks | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15828046: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_e97a7b0fd537fe53f6f8e205588044a4 |
| ToxValDB_ECHA_IUCLID | LOAEL | >=1350 | mg/kg bw/day | Rabbit | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac6ee4b0a7c65d1bf054; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/9/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821996_15823468_15823664: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_ba2a22ab2c1dbb4a930c3862a8528f5d |
| ToxValDB_ECHA_IUCLID | LOAEL | =50.4 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fc4e4b096bca877eb62; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15827022: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_48aafa8c99a7b35e98a30b9f2ad61395 |
| ToxValDB_ECHA_IUCLID | LOAEL | =25.2 | mg/m3 | Rat | inhalation | short-term; 5 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827367_15827368_15827369: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_b3f039a1afac756dabff73165269c811 |
| ToxValDB_ECHA_IUCLID | LOAEL | ~5.41 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827790_15827791: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_47306016c24d120c926b6837824027e9 |
| ToxValDB_ECHA_IUCLID | LOAEL | =25.1 | mg/m3 | Rat | inhalation | short-term; 5 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827817_15827818_15827819: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_e67559a5f80cbdcb52c5b537fed97380 |
| ToxValDB_ECHA_IUCLID | LOAEL | =50.5 | mg/m3 | Rat | inhalation | short-term; 2 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15828889_15828890: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_04f7ecbd1f6860c19b6cd9bd9e43bd84 |
| ToxValDB_ECHA_IUCLID | LOAEL | <=80 | mg/m3 | Rat | inhalation | chronic; 1 years | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15829167: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_13c0b6187b5b9de055bdc1906fa55962 |
| ToxValDB_ECHA_IUCLID | LOAEL | ~25.43 | mg/m3 | Rat | inhalation | acute; 5 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15829228: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_189fb50f20dedc11fd3ac84c277fba23 |
| ToxValDB_ECHA_IUCLID | NOAEC | <46 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827825_15828365_15829667_15829668: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_cf06625238b3afbc2a3c54bc763fc34f |
| ToxValDB_ECHA_IUCLID | NOAEC | =2 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827865_15827866_15827867_15829312: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_bffd72575273c4342a7cca757029baf3 |
| ToxValDB_ECHA_IUCLID | NOAEC | =0.5 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827865_15827866_15827867_15829312: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_dad0a761745a63857c1fa1f0e00ff1c8 |
| ToxValDB_ECHA_IUCLID | NOAEC | =10.1 | mg/m3 | Rat | inhalation | short-term; 4 weeks | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15828045: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_fd6dce6afdbdb9246db5a9dd24832657 |
| ToxValDB_ECHA_IUCLID | NOAEC | <31 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827825_15828365_15829667_15829668: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_42e2a6d18353bf9bf264f923531c4cf9 |
| ToxValDB_ECHA_IUCLID | NOAEC | =5 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827924_15827925_15827926_15828605_15828606_15828607: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_7f059da37dde95d9c9f0347c553db470 |
| ToxValDB_ECHA_IUCLID | NOAEC | =1 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827924_15827925_15827926_15828605_15828606_15828607: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_02e1f9fe214e255a18cd7a4acd2d3056 |
| ToxValDB_ECHA_IUCLID | NOAEC | =2.5 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829069_15829070_15829071: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_2340c33ef220b476adf18af8f273927c |
| ToxValDB_ECHA_IUCLID | NOAEC | >=10 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829069_15829070_15829071: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_c7e23ecd80586bf3fd8028fa8f0c6c20 |
| ToxValDB_ECHA_IUCLID | NOAEC | >=50 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829069_15829070_15829071: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_3cbede2f5a99be80dca1a5ed3c6cad15 |
| ToxValDB_ECHA_IUCLID | NOAEC | =2.05 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827865_15827866_15827867_15829312: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_5f3e4f56ff046b63a2cbeb6ab679349a |
| ToxValDB_ECHA_IUCLID | NOAEC | >1.3 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827825_15828365_15829667_15829668: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_e3e3572cc694d85fe0ab7899b759dc77 |
| ToxValDB_ECHA_IUCLID | NOAEC | <5.9 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827825_15828365_15829667_15829668: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_c30474f3129377cb7ea7c9995e75ae3f |
| ToxValDB_ECHA_IUCLID | NOAEL | ~1800 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b476e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820017_15820210: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_017dd1ce8bbeb4462967a4b090802af7 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~5000 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b4771; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820045_15820212: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_8e558cdb56ebd4972f4981de4d163791 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~4000 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b4771; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820046_15820214: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_6f9d66fb6a38723760c507cb66dd8a25 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=100 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b476b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=histopathology: neoplastic|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=cancer|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15820208: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_2a0af45ce86ea351fbb1aed6a53de563 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~3200 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b476e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820018_15820209: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_2ca8db419ac2dfe39bf9f73906fe6d0b |
| ToxValDB_ECHA_IUCLID | NOAEL | ~3000 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b476e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820017_15820210: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_f9c8ad80e60940e9297f2809df7ba718 |
| ToxValDB_ECHA_IUCLID | NOAEL | =3900 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b476e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15820211: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_f321ffbee3046ba4c47caf6d8317f06a |
| ToxValDB_ECHA_IUCLID | NOAEL | ~7000 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b4771; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820045_15820212: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_c2bea1e06dcfbb632cb4ffaae563e39a |
| ToxValDB_ECHA_IUCLID | NOAEL | =9250 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b4771; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15820213: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_e59eb581c4ece0747cdd09d76346e0f6 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~13000 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa25e4b0a7c65d1b4771; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/8?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820046_15820214: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_5e0b6e05fe4038694924075b2229d3af |
| ToxValDB_ECHA_IUCLID | NOAEL | =1000 | 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/669eac6ee4b0a7c65d1bf04e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/9/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=fetus: changes in sex ratio|fetus: fetal/pup body weight changes|fetus: external malformations|fetus: skeletal malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15820777_15821321_15821392_15821732_15825165_15825166:M/F:-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_f655684d157a1b8e244a30bc9fa93fc1 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1600 | mg/kg bw/day | Hamster | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d199e4b0a7c65d22f571; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/26622?documentUUID=667256b2-8daa-4071-ac8d-e964ca257dca; YEAR=1997; ORIGINAL_YEAR=1997; STUDY_GROUP=ECHA IUCLID:15820807:-:-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_24365309d5c7c4ad94d3f60eedda2b81 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1350 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1c2e4b0a7c65d230103; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/26622?documentUUID=667256b2-8daa-4071-ac8d-e964ca257dca; YEAR=1997; ORIGINAL_YEAR=1997; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822113_15822230_15822637_15822699_15822712_15823022_15825163_15825164: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_dda70008933e89569dedd5cc5beb390d |
| ToxValDB_ECHA_IUCLID | NOAEL | =1340 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d232e4b0a7c65d232086; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/26622?documentUUID=667256b2-8daa-4071-ac8d-e964ca257dca; YEAR=1997; ORIGINAL_YEAR=1997; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822532_15825159_15825160: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_d08ef9886e6163ed8bd66ffd9f54106e |
| ToxValDB_ECHA_IUCLID | NOAEL | >=500 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac6ee4b0a7c65d1bf057; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/9/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15825161: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_f22a4eccacad3aa4b4010713374039b2 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=10000 | mg/kg bw/day | Rabbit | dermal | short-term; 3 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d5de4b096bca87757f8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/4?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Dermal_15826142_15826275: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_1b28ef1f877e870530be35c717c72690 |
| ToxValDB_ECHA_IUCLID | NOAEL | <31 | mg/m3 | Rat | inhalation | short-term; 2 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827256_15827288: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_a39a026c5cca02a95e1741af065c7dd8 |
| ToxValDB_ECHA_IUCLID | NOAEL | <17 | mg/m3 | Rat | inhalation | short-term; 2 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827256_15827288: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_7f2646ed777d8e16efff1ed5fd393da7 |
| ToxValDB_ECHA_IUCLID | NOAEL | =5.39 | mg/m3 | Rat | inhalation | short-term; 5 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827367_15827368_15827369: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_8696476f454ab8ff0d46ece5647be93b |
| ToxValDB_ECHA_IUCLID | NOAEL | ~1.39 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827790_15827791: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_042919ebce73cd14801375baadc97cde |
| ToxValDB_ECHA_IUCLID | NOAEL | =5.13 | mg/m3 | Rat | inhalation | short-term; 5 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827817_15827818_15827819: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_022992f92281a4d1f4b2415c0a715394 |
| ToxValDB_ECHA_IUCLID | NOAEL | =5 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827995_15827996_15827997: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_02604666702e4a706e71d8e1fb807d01 |
| ToxValDB_ECHA_IUCLID | NOAEL | <1 | mg/m3 | Rat | inhalation | acute; 6 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827995_15827996_15827997: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_acd1ef76fe286b00ddf2806de86ebccb |
| ToxValDB_ECHA_IUCLID | NOAEL | ~4.97 | mg/m3 | Rat | inhalation | acute; 5 hours | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15829227: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_423ad650afde5741216ae1aec92277e2 |
| ToxValDB_ECHA_IUCLID | NOAEL | =2250 | ppm | Rat | oral | short-term; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeefe4b0a7c65d1cba8a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=liver: body weight and weight gain|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID:15846710: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_87df4b078b6cedbab2d0e7c012c9f889 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~2000 | mg/kg bw/day | Rat | oral | chronic; 103 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeeee4b0a7c65d1cba45; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15847979: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_dce149276dc1fc2f1dc65e7b608cd93a |
| ToxValDB_ECHA_IUCLID | NOAEL | =2500 | mg/kg bw/day | Rat | oral | - | repeat dose other | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeeee4b0a7c65d1cba50; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|gross pathology|haematology; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|gross pathology|hematology; STUDY_GROUP=ECHA IUCLID:15849848: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_353390048adf3fc3fc7d8a396d7df4fc |
| ToxValDB_ECHA_IUCLID | NOAEL | >=491.5 | mg/kg bw/day | Rat | oral | chronic; 6 months | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeefe4b0a7c65d1cba86; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|gross pathology|haematology|mortality|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|gross pathology|hematology|mortality/survival|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833882_15849853: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_693ac634a1dd1088a2a28df67e3b1f69 |
| ToxValDB_ECHA_IUCLID | NOAEL | =497 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab5ae4b0a7c65d1b9de9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/9/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=F1: clinical signs|F1: body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs; STUDY_GROUP=ECHA IUCLID:15859327:M/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_e871ada24e0b1e9373a534c5ea340877 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=492 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab5ae4b0a7c65d1b9dda; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/9/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15862146: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_6420d46bd47195e8b31a226cc53d634b |
| ToxValDB_ECHA_IUCLID | NOAEL | >=518 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab5ae4b0a7c65d1b9dda; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/9/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15862253: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_bcb38c14f596d746a2e5b8ceeb249544 |
| ToxValDB_ECHA_IUCLID | NOEL | =10 | mg/m3 | Rat | inhalation | short-term; 2 weeks | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fc4e4b096bca877ebd8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15827049:-:--; 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_b5867f355703f6033fe50f273ee70965 |
| ToxValDB_ECHA_IUCLID | NOEL | =1.16 | mg/m3 | Rat | inhalation | short-term; 5 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827367_15827368_15827369: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_f1bc509b4d60c5c62c3fceaef7528a3d |
| ToxValDB_ECHA_IUCLID | NOEL | =0.94 | mg/m3 | Rat | inhalation | short-term; 5 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/3?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827817_15827818_15827819: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_904efa5e19678580caecaed92adfd0dd |
| ToxValDB_ECHA_IUCLID | NOEL | >=500 | mg/kg bw/day | Rat | oral | chronic; 6 months | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbd6e4b0a7c65d227a9b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=behaviour (functional findings)|body weight and weight gain|clinical signs|food consumption and compound intake|gross pathology|haematology|mortality|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|neurobehavior|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15833882_15849853: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_5b8ba2bf8670719e2e8fd3183b7b29c2 |
| ToxValDB_ECHA_IUCLID | NOEL | >=4800 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeeee4b0a7c65d1cba37; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID:15849846: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_94f2b6224d0bfffba9978bccceddf1af |
| ToxValDB_ECHA_IUCLID | NOEL | =7950 | mg/kg bw/day | Rat | oral | chronic; 26 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeefe4b0a7c65d1cba7f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: non-neoplastic|mortality|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID:15849851: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_2b11ebdcd3612e71bae829edd8f9905d |
| ToxValDB_ECHA_IUCLID | NOEL | =8980 | mg/kg bw/day | Rat | oral | chronic; 26 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaeefe4b0a7c65d1cba7f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15556/7/6/2?documentUUID=cea0d500-d9b2-49ad-8f19-1eac4f804f72; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: non-neoplastic|mortality|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID:15849852: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_0d9afc61c9a29e20cfb47748223c7dbf |
ToxValDB_ECOTOX 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =50 | mg/kg bw/day | Mouse | oral | short-term; 5 days | short-term | LONG_REF=Toxicology282(3): 82-87 Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice 2011; TITLE=TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice; AUTHOR=Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam; DOI=10.1016/j.tox.2011.01.013; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=154284; 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=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=Genetics: Cyp1A1 mRNA; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15594583_15603676_15603677_15604650_15608467:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f657867638dec6e226b83362cfe56619 |
| ToxValDB_ECOTOX | LOEL | =500 | mg/kg bw/day | Mouse | oral | short-term; 5 days | short-term | LONG_REF=Toxicology282(3): 82-87 Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice 2011; TITLE=TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice; AUTHOR=Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam; DOI=10.1016/j.tox.2011.01.013; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=154284; 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=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=Immunological: Antibody titres; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15594583_15603676_15603677_15604650_15608467:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=de81bf7a0a05ce65d197b93df4f772c0 |
| ToxValDB_ECOTOX | LOEL | =665 | mg/kg bw/day | Mouse | oral | short-term; 5 days | short-term | LONG_REF=Toxicology282(3): 82-87 Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice 2011; TITLE=TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice; AUTHOR=Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam; DOI=10.1016/j.tox.2011.01.013; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=154284; 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=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=Immunological: Antibody titres; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15594583_15603676_15603677_15604650_15608467:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=e0a4258d8b60fc4198a2115f842df4c6 |
| ToxValDB_ECOTOX | NOEL | =100 | mg/kg bw/day | Mouse | oral | short-term; 5 days | short-term | LONG_REF=Toxicology282(3): 82-87 Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice 2011; TITLE=TCDD Adsorbed on Silica as a Model for TCDD Contaminated Soils: Evidence for Suppression of Humoral Immunity in Mice; AUTHOR=Kaplan,B.L.F., R.B. Crawford, N. Kovalova, A. Arencibia, S.S. Kim, T.J. Pinnavaia, S.A. Boyd, B.J. Teppen, and N.E. Kam; DOI=10.1016/j.tox.2011.01.013; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=154284; 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=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=Immunological: Antibody titres; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15594583_15603676_15603677_15604650_15608467:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=0912c8056ee5cb8ad6ae75abf1052cc8 |
| ToxValDB_ECOTOX | NOEL | =1.66e-16 | mM | Mouse | oral | short-term; 25 days | short-term | LONG_REF=Eur. J. Pharmacol.135(3): 313-319 Davenas,E., B. Poitevin, and J. Benveniste Effect on Mouse Peritoneal Macrophages of Orally Administered Very High Dilutions of Silica 1987; TITLE=Effect on Mouse Peritoneal Macrophages of Orally Administered Very High Dilutions of Silica; AUTHOR=Davenas,E., B. Poitevin, and J. Benveniste; DOI=10.1016/0014-2999(87)90680-7; QUALITY=Control type: Multiple control types; EXTERNAL_SOURCE_ID=101537; 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=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Immunological: Macrophage activity; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15608165_15608806:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=60037bc2e4b29edf8abf741066c4eefe |
| ToxValDB_ECOTOX | NOEL | =1.66e-8 | mM | Mouse | oral | short-term; 25 days | short-term | LONG_REF=Eur. J. Pharmacol.135(3): 313-319 Davenas,E., B. Poitevin, and J. Benveniste Effect on Mouse Peritoneal Macrophages of Orally Administered Very High Dilutions of Silica 1987; TITLE=Effect on Mouse Peritoneal Macrophages of Orally Administered Very High Dilutions of Silica; AUTHOR=Davenas,E., B. Poitevin, and J. Benveniste; DOI=10.1016/0014-2999(87)90680-7; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=101537; 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=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Immunological: Macrophage activity; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15608165_15608806:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9ac181aa80e07f7384d49a74de238460 |
ToxValDB_RSL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_RSL | RfC | =0.003 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759b87ce4b0a7c65d37b4e4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/risk/regional-screening-levels-rsls-generic-tables; STUDY_GROUP=RSL:15658924:-:--; 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_ec9afab3a9860fac4d2528b203bcb832 |
ToxValDB_TX_TCEQ 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_TX_TCEQ | LOAEL | =15 | mg/m3 | Monkey | inhalation | chronic; 18 months | chronic | LONG_REF=Groth DH, WJ Moorman, DW Lynch, LE Stettler, WD Wagner, RW Hornung. 1981. Chronic effects of inhaled amorphous silicas in animals. American Society for Testing and Materials Special Technical Publication 732, 118-143.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5acf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/silica_amorphous.pdf; YEAR=2011 Accessible 2013; ORIGINAL_YEAR=2011 Accessible 2013; TOXICOLOGICAL_EFFECT=Pulmonary effects such as chronic inflammation, respiratory impairment, and decrese in pulmonary function.; STUDY_GROUP=TX TCEQ_dup_-_15954646_15954647_15954648:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a08be49dd714b42674a829893258e58d |
| ToxValDB_TX_TCEQ | LOAEL (ADJ) | =2.679 | mg/m3 | Monkey | inhalation | chronic; 18 months | chronic | LONG_REF=Groth DH, WJ Moorman, DW Lynch, LE Stettler, WD Wagner, RW Hornung. 1981. Chronic effects of inhaled amorphous silicas in animals. American Society for Testing and Materials Special Technical Publication 732, 118-143.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5acf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/silica_amorphous.pdf; YEAR=2011 Accessible 2013; ORIGINAL_YEAR=2011 Accessible 2013; TOXICOLOGICAL_EFFECT=Pulmonary effects such as chronic inflammation, respiratory impairment, and decrese in pulmonary function.; STUDY_GROUP=TX TCEQ_dup_-_15954646_15954647_15954648:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2e4de90a320f546513766e54eb539339 |
| ToxValDB_TX_TCEQ | LOAEL (HEC) | =1.98 | mg/m3 | Monkey | inhalation | chronic; 18 months | chronic | LONG_REF=Groth DH, WJ Moorman, DW Lynch, LE Stettler, WD Wagner, RW Hornung. 1981. Chronic effects of inhaled amorphous silicas in animals. American Society for Testing and Materials Special Technical Publication 732, 118-143.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5acf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/silica_amorphous.pdf; YEAR=2011 Accessible 2013; ORIGINAL_YEAR=2011 Accessible 2013; TOXICOLOGICAL_EFFECT=Pulmonary effects such as chronic inflammation, respiratory impairment, and decrese in pulmonary function.; STUDY_GROUP=TX TCEQ_dup_-_15954646_15954647_15954648:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_16acbd40ab2b952caf5530118aa9b854 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 4 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=unclear:xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi; EFFECT=xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"","duration":"","effect":"xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi","endpoint":"","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:xicity of SAS materials. However, it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submi","page":59,"route":"","species":"","study_id":"sccs_o_175_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 4 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=unclear:it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submission c; EFFECT=it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submission c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"","duration":"","effect":"it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submission c","endpoint":"","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:it is worth noting that the type of SAS approved for use in food applications relates only to the neat (i.e. not surface modified) pyrogenic amorphous silica, and not to the different SAS types included in the current submission. Also, the SCCS could not identify any original epidemiological study either in the submission or in the open literature that could be considered relevant to the current evaluation of SAS safety in cosmetic products. Safety Assessment In the absence of a No Observed Adverse Effect Level (NOAEL) value and exposure estimates, calculation of margin of safety (MOS) is not possible. 4. CONCLUSION Q1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterials Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate for use in leave-on and rinse-off cosmetics products, including hair, skin, lip, face, and nail products, taking into account the reasonably foreseeable exposure conditions. The submission c","page":59,"route":"","species":"","study_id":"sccs_o_175_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | % | - | oral | 90 days | - | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=5; EFFECT=igns of toxicity, and body weight changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open; CITATION=Ref.: Pr-A (1958) in OECD (2004) Relevant Open; CITATION_NUMBERS=[1958,2004]; REFERENCE=Ref.: Pr-A (1958) in OECD (2004) Relevant Open; DETAILS_JSON={"cas_number":"7631-86-9","citation":"Ref.: Pr-A (1958) in OECD (2004) Relevant Open","dose":"","duration":"90 days","effect":"igns of toxicity, and body weight changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open","endpoint":"","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"%","noael_value":"5","page":32,"route":"oral","species":"","study_id":"sccs_o_175_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | % | - | oral | 90 days | - | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=5; EFFECT=changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open Literat; CITATION=Ref.: Pr-A (1958) in OECD (2004) Relevant Open Literat; CITATION_NUMBERS=[1958,2004]; REFERENCE=Ref.: Pr-A (1958) in OECD (2004) Relevant Open Literat; DETAILS_JSON={"cas_number":"7631-86-9","citation":"Ref.: Pr-A (1958) in OECD (2004) Relevant Open Literat","dose":"","duration":"90 days","effect":"changes; food consumption and survival rates were similar between groups including controls. No gross observations or histopathological changes that could be attributed to administration of P-SAS-A-10 were observed. Following ingestion of the diet containing high SAS levels, the SiO2 contents of liver, kidney, spleen, blood, and urine for the period of 45 and 90 days showed no deposition of SiO2 when compared to the controls. Conclusions Under the conditions of the present study, No Observed Adverse Effect Level (NOAEL) of P- SAS-A-10 fluffy was above 5% in-diet (i.e. 3500 mg/kg). SCCS comment The study preceded OECD guidelines and GLP. The material used was not specified and it is not clear whether the study material was comparable to Py-SAS-A-8; Py-SAS-NA-4, the two similarly named materials (but different in terms of surface characteristics) covered by the submission. Further, only a study summary was provided. No conclusions can be drawn from the information provided. Ref.: Pr-A (1958) in OECD (2004) Relevant Open Literat","endpoint":"","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"%","noael_value":"5","page":32,"route":"oral","species":"","study_id":"sccs_o_175_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg | - | - | 3-week | - | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=500; DOSE=At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.; EFFECT=in organ weight and no macroscopic findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.","duration":"3-week","effect":"in organ weight and no macroscopic findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.","endpoint":"","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"mg/kg","noael_value":"500","page":33,"route":"","species":"","study_id":"sccs_o_175_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg | - | - | 3-week | - | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=500; DOSE=At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.; EFFECT=c findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg.","duration":"3-week","effect":"c findings attributed to the administration of the test item. At histopathological examination, increased lipid contents in the fasciculate zone of adrenal glands were observed in some animals given 500 mg/kg. These minor changes were no longer observed after the 3-week recovery period. These slight progressive changes in the adrenals were therefore regarded as reversible, attributed to chronic stress and considered to be non-adverse. Under the conditions of the present study, the No Observed Adverse Effect Level (NOAEL) of Py-SAS-NA-2 was above 500 mg/kg.","endpoint":"","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"mg/kg","noael_value":"500","page":33,"route":"","species":"","study_id":"sccs_o_175_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1340 | mg/kg/day | rat | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=1340; DOSE=(1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15).; EFFECT=icant’s conclusion, the study cannot be considered as adequate. Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al. (1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15). The administration of SAS-G-1 did not affect foetal survival and produced no changes in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both matern; CITATION=Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al; CITATION_NUMBERS=[1965,2003]; REFERENCE=Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al; DETAILS_JSON={"cas_number":"7631-86-9","citation":"Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al","dose":"(1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15).","duration":"Developmental","effect":"icant’s conclusion, the study cannot be considered as adequate. Ref.: Pr-B (1965) in IUCLID (2003) Lewinson J et al. (1994) 3.3.8.3 Developmental Toxicity The potential effects of SAS-G-1, a silica gel material, on embryo-foetal development were evaluated through daily oral gavage at 0, 13.4, 62.3, 289, and 1340 mg/kg/day to pregnant female mice during the sensitive period of organogenesis (gestation days 6 to 15). The administration of SAS-G-1 did not affect foetal survival and produced no changes in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both matern","endpoint":"developmental toxicity","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1340","page":52,"route":"oral","species":"rat","study_id":"sccs_o_175_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1350 | mg/kg/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=1350; DOSE=The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973).; EFFECT=es in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both maternal and developmental toxicity was above 1350 mg/kg/day (US-FDA, 1973). Finally, the absence of maternal and developmental toxicity potential of SAS-G-1 was confirmed in two studies conducted in rabbits and hamsters. SAS-G-1 was administered at the dose levels 0, 16, 74.3, 345, and 1600 mg/kg/day by gavage to pregnant rabbits and hamsters during the sensitive period of organogenesis. The test material had no toxic potential in dams and conceptuses, and specifically no teratogenic potential. The NOEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973).","duration":"developmental","effect":"es in dams. The NOEL for maternal and developmental toxicity was therefore above 1340 mg/kg/day (US-FDA, 1973). Likewise, the administration of SAS-G-1 to pregnant rats at the dose levels 0, 13.5, 62.7, 292, and 1350 mg/kg/day by gavage during the sensitive period of organogenesis produced no changes in dams and did not affect fetal survival rate. The soft tissue and skeletal abnormalities observed in animals given SAS-G-1 were similar in nature and incidence to those observed in the control group. Therefore, the NOEL for both maternal and developmental toxicity was above 1350 mg/kg/day (US-FDA, 1973). Finally, the absence of maternal and developmental toxicity potential of SAS-G-1 was confirmed in two studies conducted in rabbits and hamsters. SAS-G-1 was administered at the dose levels 0, 16, 74.3, 345, and 1600 mg/kg/day by gavage to pregnant rabbits and hamsters during the sensitive period of organogenesis. The test material had no toxic potential in dams and conceptuses, and specifically no teratogenic potential. The NOEL","endpoint":"developmental toxicity","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1350","page":52,"route":"oral","species":"rat","study_id":"sccs_o_175_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 6.7 | % | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=6.7; DOSE=eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day.; EFFECT=eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn fr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day.","duration":"subchronic","effect":"eved during the study were about 300-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn fr","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"%","noael_value":"6.7","page":31,"route":"oral","species":"","study_id":"sccs_o_175_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 6.7 | % | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=6.7; DOSE=00-330, 1200-1400 and 4000-4500 mg/kg/day.; EFFECT=00-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn from the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"00-330, 1200-1400 and 4000-4500 mg/kg/day.","duration":"subchronic","effect":"00-330, 1200-1400 and 4000-4500 mg/kg/day. There were no deaths, no adverse clinical signs attributed to P-SAS-A-9 and no other findings at haematological, blood-chemical, urinary and histopathological examinations. Mean food intake was slightly higher in the female high dose group when compared to controls, with no associated changes in body weight gain. These minor, isolated changes were not observed in males and considered to be non-toxicologically significant. Conclusions The No Observed Adverse Effect Level (NOAEL) of P-SAS-A-9 in the present study was above 6.7% in-diet i.e. above 4000-4500 mg/kg. SCCS comment No information on the Batch of P-SAS-A-9 used in the toxicity study is given. No information on OECD and GLP-adherence is given. Tissues/organs investigated were not specified. Further, only a study summary is given which is considered as second hand information. In order to be able to properly evaluate the subchronic toxicity of P-SAS-A-9, the original study report is required. No conclusions can be drawn from the","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"%","noael_value":"6.7","page":31,"route":"oral","species":"","study_id":"sccs_o_175_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 500 | mg/kg/day | rat | oral | 4-week | reproductive toxicity | SOURCE_SUBDIR=sccs_o_175; REPORT_TITLE=OPINION ON Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form); OPINION_NUMBER=SCCS/1545/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=29 September 2015; VALUE_TEXT=500; DOSE=Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item.; EFFECT=on litter size, pup weight at birth and pup appearance and behaviour. Pup development over the 4-week lactation period was not affected by administration of Py-SAS-NA-2, and no salient macroscopic findings were noted in pups at the end of the study. Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item. Accordingly, under the conditions of the present study, the No Observed Effect Level (NOEL) was above 500 mg/kg/day for male and female reproductive performance as well as pre- natal and post-natal development. SCCS comment Information on material characterisation for Py-SAS-NA-2 batch 31520315221 dates from 2013 and was provided to the SCCS. The toxicological study however was performed in 1965 and no information on the batch of Py-SAS-NA-2 used in the toxicity study is given. Thus, it is not clear, whether the material used for the reproductive toxicity study 4 decades ago exhibits the same physico-c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7631-86-9","citation":"","dose":"Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item.","duration":"4-week","effect":"on litter size, pup weight at birth and pup appearance and behaviour. Pup development over the 4-week lactation period was not affected by administration of Py-SAS-NA-2, and no salient macroscopic findings were noted in pups at the end of the study. Conclusion In summary, the oral administration of Py-SAS-NA-2 at 500 mg/kg/day to rats during the mating, gestation and lactation periods produced no changes attributed to test item. Accordingly, under the conditions of the present study, the No Observed Effect Level (NOEL) was above 500 mg/kg/day for male and female reproductive performance as well as pre- natal and post-natal development. SCCS comment Information on material characterisation for Py-SAS-NA-2 batch 31520315221 dates from 2013 and was provided to the SCCS. The toxicological study however was performed in 1965 and no information on the batch of Py-SAS-NA-2 used in the toxicity study is given. Thus, it is not clear, whether the material used for the reproductive toxicity study 4 decades ago exhibits the same physico-c","endpoint":"reproductive toxicity","ingredient":"codes.................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"500","page":52,"route":"oral","species":"rat","study_id":"sccs_o_175_noael_007"} |
openFDA substances 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | ETJ7Z6XBU4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O2Si","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ETJ7Z6XBU4"} |
| openFDA substances | FDA UNII substance identifier | ETJ7Z6XBU4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O2Si","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ETJ7Z6XBU4"} |
| openFDA substances | FDA UNII substance identifier | ETJ7Z6XBU4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O2Si","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ETJ7Z6XBU4"} |
| openFDA substances | FDA UNII substance identifier | ETJ7Z6XBU4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O2Si","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ETJ7Z6XBU4"} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |