NOAEL Studies
Cosmetic Ingredient
Hydroxyethyl-3,4-Methylenedioxyaniline HCl NOAEL Studies
INCI: HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL
CAS: 94158-14-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =20 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"(350; 100; 20","dose":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d).","effect":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d). At the 100 mg/kg/ d dosage rate, bilirubin and phospholipid levels (clinical biochemistry parameters) were elevated in females, increases in absolute and relative liver weights and hepatocellular hy- pertrophy were noted in males, and increases in blood cho- lesterol and urinary volume occurred in both sexes. A no- observed-adverse-effect level (NOAEL) of 20 mg/kg/d was reported. Developmental and Reproductive Toxicity (DART) Studies A teratogenicity study was conducted in accordance with OECD TG 414 and GLP to evaluate Hydroxyethyl-3,4- Methylenedioxyaniline HCl (purity 99.8%) in rats (HanBrl: WIST, SPF quality).2 The test substance in bi-distilled water was administered by gavage to pregnant rats (n=22/group) on days 6 to 20 of gestation at 0, 50, 250, and 1000 mg/kg/d. All animals were killed on day 21 of gestation and necropsies were performed. Instability of the test solution was reported in this study (ass...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_001"} |
| CIR_vision_codex | NOAEL | =26 | mg/kg/d | mouse | - | - | developmental toxicity | {"citation":"688; 152; 2","dose":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs.","effect":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs. Treatment-related effects were seen on cervical and thoracic vertebrae and on costal cartilage in the 152 mg/kg/d and 688 mg/kg/d groups. The SCCS report states that the severe reproductive and developmental effects at the 688 mg/kg/d and 152 mg/kg/d dosage rates were caused by maternal toxicity.2 A repro- ductive and developmental NOAEL of 26 mg/kg/d was reported. Genotoxicity Studies Provided below is a summary of genotoxicity studies that are presented in detail in Table 3. Experiments examining Hydroxyethyl-3,4- Methylenedioxyaniline HCl were conducted in vitro. An Ames test using Salmonella typhimurium was negative for genotoxicity up to 5000 μg/plate.2 A mammalian cell gene mutation assay using mouse lymphoma cells was non- mutagenic during a 4-h incubation with concentrations up to 1100 μg/ml with metabolic activation and up to 1650 μg/ml without activation. In an in vitro micronucleus test...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_002"} |
| CIR_vision_codex | NOAEL | =20 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"(350; 100; 20","dose":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d).","effect":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d). At the 100 mg/kg/ d dosage rate, bilirubin and phospholipid levels (clinical biochemistry parameters) were elevated in females, increases in absolute and relative liver weights and hepatocellular hy- pertrophy were noted in males, and increases in blood cho- lesterol and urinary volume occurred in both sexes. A no- observed-adverse-effect level (NOAEL) of 20 mg/kg/d was reported. Developmental and Reproductive Toxicity (DART) Studies A teratogenicity study was conducted in accordance with OECD TG 414 and GLP to evaluate Hydroxyethyl-3,4- Methylenedioxyaniline HCl (purity 99.8%) in rats (HanBrl: WIST, SPF quality).2 The test substance in bi-distilled water was administered by gavage to pregnant rats (n=22/group) on days 6 to 20 of gestation at 0, 50, 250, and 1000 mg/kg/d. All animals were killed on day 21 of gestation and necropsies were performed. Instability of the test solution was reported in this study (ass...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_001"} |
| CIR_vision_codex | NOAEL | =26 | mg/kg/d | mouse | - | - | developmental toxicity | {"citation":"688; 152; 2","dose":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs.","effect":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs. Treatment-related effects were seen on cervical and thoracic vertebrae and on costal cartilage in the 152 mg/kg/d and 688 mg/kg/d groups. The SCCS report states that the severe reproductive and developmental effects at the 688 mg/kg/d and 152 mg/kg/d dosage rates were caused by maternal toxicity.2 A repro- ductive and developmental NOAEL of 26 mg/kg/d was reported. Genotoxicity Studies Provided below is a summary of genotoxicity studies that are presented in detail in Table 3. Experiments examining Hydroxyethyl-3,4- Methylenedioxyaniline HCl were conducted in vitro. An Ames test using Salmonella typhimurium was negative for genotoxicity up to 5000 μg/plate.2 A mammalian cell gene mutation assay using mouse lymphoma cells was non- mutagenic during a 4-h incubation with concentrations up to 1100 μg/ml with metabolic activation and up to 1650 μg/ml without activation. In an in vitro micronucleus test...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_002"} |
| CIR_vision_codex | NOAEL | =20 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"(350; 100; 20","dose":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d).","effect":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d). At the 100 mg/kg/ d dosage rate, bilirubin and phospholipid levels (clinical biochemistry parameters) were elevated in females, increases in absolute and relative liver weights and hepatocellular hy- pertrophy were noted in males, and increases in blood cho- lesterol and urinary volume occurred in both sexes. A no- observed-adverse-effect level (NOAEL) of 20 mg/kg/d was reported. Developmental and Reproductive Toxicity (DART) Studies A teratogenicity study was conducted in accordance with OECD TG 414 and GLP to evaluate Hydroxyethyl-3,4- Methylenedioxyaniline HCl (purity 99.8%) in rats (HanBrl: WIST, SPF quality).2 The test substance in bi-distilled water was administered by gavage to pregnant rats (n=22/group) on days 6 to 20 of gestation at 0, 50, 250, and 1000 mg/kg/d. All animals were killed on day 21 of gestation and necropsies were performed. Instability of the test solution was reported in this study (ass...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_001"} |
| CIR_vision_codex | NOAEL | =26 | mg/kg/d | mouse | - | - | developmental toxicity | {"citation":"688; 152; 2","dose":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs.","effect":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs. Treatment-related effects were seen on cervical and thoracic vertebrae and on costal cartilage in the 152 mg/kg/d and 688 mg/kg/d groups. The SCCS report states that the severe reproductive and developmental effects at the 688 mg/kg/d and 152 mg/kg/d dosage rates were caused by maternal toxicity.2 A repro- ductive and developmental NOAEL of 26 mg/kg/d was reported. Genotoxicity Studies Provided below is a summary of genotoxicity studies that are presented in detail in Table 3. Experiments examining Hydroxyethyl-3,4- Methylenedioxyaniline HCl were conducted in vitro. An Ames test using Salmonella typhimurium was negative for genotoxicity up to 5000 μg/plate.2 A mammalian cell gene mutation assay using mouse lymphoma cells was non- mutagenic during a 4-h incubation with concentrations up to 1100 μg/ml with metabolic activation and up to 1650 μg/ml without activation. In an in vitro micronucleus test...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_002"} |
| CIR_vision_codex | NOAEL | =20 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"(350; 100; 20","dose":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d).","effect":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d). At the 100 mg/kg/ d dosage rate, bilirubin and phospholipid levels (clinical biochemistry parameters) were elevated in females, increases in absolute and relative liver weights and hepatocellular hy- pertrophy were noted in males, and increases in blood cho- lesterol and urinary volume occurred in both sexes. A no- observed-adverse-effect level (NOAEL) of 20 mg/kg/d was reported. Developmental and Reproductive Toxicity (DART) Studies A teratogenicity study was conducted in accordance with OECD TG 414 and GLP to evaluate Hydroxyethyl-3,4- Methylenedioxyaniline HCl (purity 99.8%) in rats (HanBrl: WIST, SPF quality).2 The test substance in bi-distilled water was administered by gavage to pregnant rats (n=22/group) on days 6 to 20 of gestation at 0, 50, 250, and 1000 mg/kg/d. All animals were killed on day 21 of gestation and necropsies were performed. Instability of the test solution was reported in this study (ass...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_001"} |
| CIR_vision_codex | NOAEL | =26 | mg/kg/d | mouse | - | - | developmental toxicity | {"citation":"688; 152; 2","dose":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs.","effect":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs. Treatment-related effects were seen on cervical and thoracic vertebrae and on costal cartilage in the 152 mg/kg/d and 688 mg/kg/d groups. The SCCS report states that the severe reproductive and developmental effects at the 688 mg/kg/d and 152 mg/kg/d dosage rates were caused by maternal toxicity.2 A repro- ductive and developmental NOAEL of 26 mg/kg/d was reported. Genotoxicity Studies Provided below is a summary of genotoxicity studies that are presented in detail in Table 3. Experiments examining Hydroxyethyl-3,4- Methylenedioxyaniline HCl were conducted in vitro. An Ames test using Salmonella typhimurium was negative for genotoxicity up to 5000 μg/plate.2 A mammalian cell gene mutation assay using mouse lymphoma cells was non- mutagenic during a 4-h incubation with concentrations up to 1100 μg/ml with metabolic activation and up to 1650 μg/ml without activation. In an in vitro micronucleus test...","page":9,"pdf":"PRS732.pdf","row_type":"noael_study","study_id":"PRS732_noael_002"} |
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 100 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; Braun, W. H.; Hydroxyethyl-3,4-methylene-dioxyaniline HCl (WR 23094): 13-weekoral toxicity (gavage) study in Wistar rats; RCC; |
| COSMOS_DB | NOAEL | 20 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; Braun, W. H.; Hydroxyethyl-3,4-methylene-dioxyaniline HCl (WR 23094): 13-weekoral toxicity (gavage) study in Wistar rats; RCC; |
SCCS_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 3","dose":"In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only).","effect":"r damage. In females extramedullary haematopoiesis was observed in the spleen and corpus luteum hypertrophy in the ovaries. In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only). Increased urinary volume was noted. Abs. and relative liver weights in males were increased, and hepatocellular hypertrophy was observed (most pronounced in males). At 20 mg/kg bw/day no adverse effects were observed. Conclusion The NOAEL in this study was 20 mg/kg bw/day. Ref.: 26 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Assay conditions: Plate incorporation and pre-incubation assay without and with S9 mix from rat livers (phenobarbital/ß-naphthoflavone induced). Three plates were investigated per test concentration","page":16,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.","effect":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Tox","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_002"} |
| SCCS_vision_codex | NOAEL | =25.7 | mg/kg bw | human | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"the lowest dose level.","effect":"the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 120 min Number of experiments: two independent experiments GLP: not in compliance,","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg | rabbit | oral | - | NOAEL study | {"effect":"an Ratten; REPROTOX HUNTINGDON; 1981 - Osterburg, I.; 1-ß-Hydroxyethylamino-3,4-methylendioxybenzene oral (gavage) teratology study in the New Zealand White rabbit; HAZLETON; 1982 - Richold, M.; Micronucleus test on 1-ß-Hydroxyethylamino-3,4-methylenedioxybenzene dihydrochloride; HUNTINGDON; 1981 - Schoental, R.; Carcinogens in plants and microorganisms; ACS; 173, 626-648; 1976 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) zur Überprüfung eines NOAEL bei einer Dosierung von 20mg/kg Körpergewicht nach oraler Applikation an Ratten Appendix zu IBR Projekt 2-4- 280-81; IBR; 1982 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) mit anschließender 4-wöchiger Reversalzeit nach oraler Applikation an Ratten; IBR; 1982 - Weide, J.; Sensibilisierungstest am Albinomeerschweinchen mit 1-ß-Hydroxyethylamino- 3,4-methylendioxy-benzol; WELLA AG; 1985 - Wenker, M.A.M.; Absorption, distribution, metabolism and","page":31,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_010"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 3","dose":"In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only).","effect":"r damage. In females extramedullary haematopoiesis was observed in the spleen and corpus luteum hypertrophy in the ovaries. In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only). Increased urinary volume was noted. Abs. and relative liver weights in males were increased, and hepatocellular hypertrophy was observed (most pronounced in males). At 20 mg/kg bw/day no adverse effects were observed. Conclusion The NOAEL in this study was 20 mg/kg bw/day. Ref.: 26 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Assay conditions: Plate incorporation and pre-incubation assay without and with S9 mix from rat livers (phenobarbital/ß-naphthoflavone induced). Three plates were investigated per test concentration","page":16,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.","effect":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Tox","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_002"} |
| SCCS_vision_codex | NOAEL | =25.7 | mg/kg bw | human | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"the lowest dose level.","effect":"the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 120 min Number of experiments: two independent experiments GLP: not in compliance,","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg | rabbit | oral | - | NOAEL study | {"effect":"an Ratten; REPROTOX HUNTINGDON; 1981 - Osterburg, I.; 1-ß-Hydroxyethylamino-3,4-methylendioxybenzene oral (gavage) teratology study in the New Zealand White rabbit; HAZLETON; 1982 - Richold, M.; Micronucleus test on 1-ß-Hydroxyethylamino-3,4-methylenedioxybenzene dihydrochloride; HUNTINGDON; 1981 - Schoental, R.; Carcinogens in plants and microorganisms; ACS; 173, 626-648; 1976 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) zur Überprüfung eines NOAEL bei einer Dosierung von 20mg/kg Körpergewicht nach oraler Applikation an Ratten Appendix zu IBR Projekt 2-4- 280-81; IBR; 1982 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) mit anschließender 4-wöchiger Reversalzeit nach oraler Applikation an Ratten; IBR; 1982 - Weide, J.; Sensibilisierungstest am Albinomeerschweinchen mit 1-ß-Hydroxyethylamino- 3,4-methylendioxy-benzol; WELLA AG; 1985 - Wenker, M.A.M.; Absorption, distribution, metabolism and","page":31,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_010"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 3","dose":"In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only).","effect":"r damage. In females extramedullary haematopoiesis was observed in the spleen and corpus luteum hypertrophy in the ovaries. In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only). Increased urinary volume was noted. Abs. and relative liver weights in males were increased, and hepatocellular hypertrophy was observed (most pronounced in males). At 20 mg/kg bw/day no adverse effects were observed. Conclusion The NOAEL in this study was 20 mg/kg bw/day. Ref.: 26 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Assay conditions: Plate incorporation and pre-incubation assay without and with S9 mix from rat livers (phenobarbital/ß-naphthoflavone induced). Three plates were investigated per test concentration","page":16,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.","effect":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Tox","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_002"} |
| SCCS_vision_codex | NOAEL | =25.7 | mg/kg bw | human | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"the lowest dose level.","effect":"the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 120 min Number of experiments: two independent experiments GLP: not in compliance,","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg | rabbit | oral | - | NOAEL study | {"effect":"an Ratten; REPROTOX HUNTINGDON; 1981 - Osterburg, I.; 1-ß-Hydroxyethylamino-3,4-methylendioxybenzene oral (gavage) teratology study in the New Zealand White rabbit; HAZLETON; 1982 - Richold, M.; Micronucleus test on 1-ß-Hydroxyethylamino-3,4-methylenedioxybenzene dihydrochloride; HUNTINGDON; 1981 - Schoental, R.; Carcinogens in plants and microorganisms; ACS; 173, 626-648; 1976 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) zur Überprüfung eines NOAEL bei einer Dosierung von 20mg/kg Körpergewicht nach oraler Applikation an Ratten Appendix zu IBR Projekt 2-4- 280-81; IBR; 1982 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) mit anschließender 4-wöchiger Reversalzeit nach oraler Applikation an Ratten; IBR; 1982 - Weide, J.; Sensibilisierungstest am Albinomeerschweinchen mit 1-ß-Hydroxyethylamino- 3,4-methylendioxy-benzol; WELLA AG; 1985 - Wenker, M.A.M.; Absorption, distribution, metabolism and","page":31,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_010"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 3","dose":"In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only).","effect":"r damage. In females extramedullary haematopoiesis was observed in the spleen and corpus luteum hypertrophy in the ovaries. In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only). Increased urinary volume was noted. Abs. and relative liver weights in males were increased, and hepatocellular hypertrophy was observed (most pronounced in males). At 20 mg/kg bw/day no adverse effects were observed. Conclusion The NOAEL in this study was 20 mg/kg bw/day. Ref.: 26 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Assay conditions: Plate incorporation and pre-incubation assay without and with S9 mix from rat livers (phenobarbital/ß-naphthoflavone induced). Three plates were investigated per test concentration","page":16,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.","effect":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Tox","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_002"} |
| SCCS_vision_codex | NOAEL | =25.7 | mg/kg bw | human | - | 7 days | NOAEL study | {"citation":"Ref.: 31 3","dose":"the lowest dose level.","effect":"the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 120 min Number of experiments: two independent experiments GLP: not in compliance,","page":24,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg | rabbit | oral | - | NOAEL study | {"effect":"an Ratten; REPROTOX HUNTINGDON; 1981 - Osterburg, I.; 1-ß-Hydroxyethylamino-3,4-methylendioxybenzene oral (gavage) teratology study in the New Zealand White rabbit; HAZLETON; 1982 - Richold, M.; Micronucleus test on 1-ß-Hydroxyethylamino-3,4-methylenedioxybenzene dihydrochloride; HUNTINGDON; 1981 - Schoental, R.; Carcinogens in plants and microorganisms; ACS; 173, 626-648; 1976 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) zur Überprüfung eines NOAEL bei einer Dosierung von 20mg/kg Körpergewicht nach oraler Applikation an Ratten Appendix zu IBR Projekt 2-4- 280-81; IBR; 1982 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) mit anschließender 4-wöchiger Reversalzeit nach oraler Applikation an Ratten; IBR; 1982 - Weide, J.; Sensibilisierungstest am Albinomeerschweinchen mit 1-ß-Hydroxyethylamino- 3,4-methylendioxy-benzol; WELLA AG; 1985 - Wenker, M.A.M.; Absorption, distribution, metabolism and","page":31,"pdf":"sccp_o_044.pdf","row_type":"noael_study","study_id":"sccp_o_044_noael_010"} |
ToxValDB_ECHA_IUCLID 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =26 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac93e4b0a7c65d1bfd02; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22545/7/9/3?documentUUID=60e60b89-1aac-4b41-a165-5643688e4133; YEAR=1985; ORIGINAL_YEAR=1985; TOXICOLOGICAL_EFFECT=fetus: fetal/pup body weight changes|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821098:-:-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_ba388a2707de8a64a912c847cf68599a |
| ToxValDB_ECHA_IUCLID | NOAEL | =20 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf7fe4b0a7c65d1ce1d2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22545/7/6/2?documentUUID=60e60b89-1aac-4b41-a165-5643688e4133; YEAR=1985; ORIGINAL_YEAR=1985; TOXICOLOGICAL_EFFECT=liver: behaviour (functional findings)|clinical biochemistry|histopathology: non-neoplastic|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|neurobehavior|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID:15836630: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_7e6baf0b070a95da2843caae6b961261 |
UnifiedCodex:CIR:beta.noael_studies 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 20 | mg/kg/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS732; REPORT_TITLE=Safety Assessment of Hydroxyethyl-3,4-Methylenedioxyaniline HCl as Used in Cosmetics Laura N Scott, MS1, Wilma F. Bergfeld, MD FACP2, Donald V. Belsito, MD2, Ronald A. Hill, PhD3, Curtis D. Klaassen, PhD2, Daniel C. Liebler, PhD2, James G.; OPINION_NUMBER=PRS732; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=10 The 2016; VALUE_TEXT=20; DOSE=y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d).; EFFECT=y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d). At the 100 mg/kg/ d dosage rate, bilirubin and phospholipid levels (clinical biochemistry parameters) were elevated in females, increases in absolute and relative liver weights and hepatocellular hy- pertrophy were noted in males, and increases in blood cho- lesterol and urinary volume occurred in both sexes. A no- observed-adverse-effect level (NOAEL) of 20 mg/kg/d was reported. Developmental and Reproductive Toxicity (DART) Studies A teratogenicity study was conducted in accordance with OECD TG 414 and GLP to evaluate Hydroxyethyl-3,4- Methylenedioxyaniline HCl (purity 99.8%) in rats (HanBrl: WIST, SPF quality).2 The test substance in bi-distilled water was administered by gavage to pregnant rats (n=22/group) on days 6 to 20 of gestation at 0, 50, 250, and 1000 mg/kg/d. All animals were killed on day 21 of gestation and necropsies were performed. Instability of the test solution was reported in this study (ass...; CITATION=(350; 100; 20; CITATION_NUMBERS=[350,100,20]; REFERENCE=(350; 100; 20; DETAILS_JSON={"cas_number":"94158-14-2","citation":"(350; 100; 20","dose":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d).","duration":"","effect":"y param- eters, increased liver and kidney weights, increased urine volume, hepatocellular hypertrophy, and renal tubular damage were reported in both sexes (350 mg/kg/d). At the 100 mg/kg/ d dosage rate, bilirubin and phospholipid levels (clinical biochemistry parameters) were elevated in females, increases in absolute and relative liver weights and hepatocellular hy- pertrophy were noted in males, and increases in blood cho- lesterol and urinary volume occurred in both sexes. A no- observed-adverse-effect level (NOAEL) of 20 mg/kg/d was reported. Developmental and Reproductive Toxicity (DART) Studies A teratogenicity study was conducted in accordance with OECD TG 414 and GLP to evaluate Hydroxyethyl-3,4- Methylenedioxyaniline HCl (purity 99.8%) in rats (HanBrl: WIST, SPF quality).2 The test substance in bi-distilled water was administered by gavage to pregnant rats (n=22/group) on days 6 to 20 of gestation at 0, 50, 250, and 1000 mg/kg/d. All animals were killed on day 21 of gestation and necropsies were performed. Instability of the test solution was reported in this study (ass...","endpoint":"developmental toxicity","ingredient":"Hydroxyethyl-3,4-Methylenedioxyaniline HCl","loael_value":"","noael_unit":"mg/kg/d","noael_value":"20","page":9,"route":"oral","species":"rat","study_id":"PRS732_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 26 | mg/kg/d | mouse | - | - | developmental toxicity | SOURCE_SUBDIR=PRS732; REPORT_TITLE=Safety Assessment of Hydroxyethyl-3,4-Methylenedioxyaniline HCl as Used in Cosmetics Laura N Scott, MS1, Wilma F. Bergfeld, MD FACP2, Donald V. Belsito, MD2, Ronald A. Hill, PhD3, Curtis D. Klaassen, PhD2, Daniel C. Liebler, PhD2, James G.; OPINION_NUMBER=PRS732; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=10 The 2016; VALUE_TEXT=26; DOSE=g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs.; EFFECT=g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs. Treatment-related effects were seen on cervical and thoracic vertebrae and on costal cartilage in the 152 mg/kg/d and 688 mg/kg/d groups. The SCCS report states that the severe reproductive and developmental effects at the 688 mg/kg/d and 152 mg/kg/d dosage rates were caused by maternal toxicity.2 A repro- ductive and developmental NOAEL of 26 mg/kg/d was reported. Genotoxicity Studies Provided below is a summary of genotoxicity studies that are presented in detail in Table 3. Experiments examining Hydroxyethyl-3,4- Methylenedioxyaniline HCl were conducted in vitro. An Ames test using Salmonella typhimurium was negative for genotoxicity up to 5000 μg/plate.2 A mammalian cell gene mutation assay using mouse lymphoma cells was non- mutagenic during a 4-h incubation with concentrations up to 1100 μg/ml with metabolic activation and up to 1650 μg/ml without activation. In an in vitro micronucleus test...; CITATION=688; 152; 2; CITATION_NUMBERS=[688,152,2]; REFERENCE=688; 152; 2; DETAILS_JSON={"cas_number":"94158-14-2","citation":"688; 152; 2","dose":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs.","duration":"","effect":"g/d and 688 mg/kg/d, there was an increase in non-ossified and in- completely ossified bones of the cranium, vertebrae, ribs, sternebrae, and also of extremities and supernumerary ribs. Treatment-related effects were seen on cervical and thoracic vertebrae and on costal cartilage in the 152 mg/kg/d and 688 mg/kg/d groups. The SCCS report states that the severe reproductive and developmental effects at the 688 mg/kg/d and 152 mg/kg/d dosage rates were caused by maternal toxicity.2 A repro- ductive and developmental NOAEL of 26 mg/kg/d was reported. Genotoxicity Studies Provided below is a summary of genotoxicity studies that are presented in detail in Table 3. Experiments examining Hydroxyethyl-3,4- Methylenedioxyaniline HCl were conducted in vitro. An Ames test using Salmonella typhimurium was negative for genotoxicity up to 5000 μg/plate.2 A mammalian cell gene mutation assay using mouse lymphoma cells was non- mutagenic during a 4-h incubation with concentrations up to 1100 μg/ml with metabolic activation and up to 1650 μg/ml without activation. In an in vitro micronucleus test...","endpoint":"developmental toxicity","ingredient":"Hydroxyethyl-3,4-Methylenedioxyaniline HCl","loael_value":"","noael_unit":"mg/kg/d","noael_value":"26","page":9,"route":"","species":"mouse","study_id":"PRS732_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw | - | - | 7 days | - | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=50; DOSE=_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.; EFFECT=_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Tox; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"94158-14-2","citation":"Ref.: 31 3","dose":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.","duration":"7 days","effect":"_________________________ 24 tolerated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Tox","endpoint":"","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":24,"route":"","species":"","study_id":"sccp_o_044_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw | - | - | 7 days | - | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=50; DOSE=ated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.; EFFECT=ated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokine; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"94158-14-2","citation":"Ref.: 31 3","dose":"ated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death.","duration":"7 days","effect":"ated dose was clearly exceeded as it led to pronounced maternal toxicity and several cases of death. The effects at this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokine","endpoint":"","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":24,"route":"","species":"","study_id":"sccp_o_044_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw | human | - | 7 days | - | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=50; DOSE=this dose level were therefore considered to be due to the high maternal toxicity.; EFFECT=this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / C; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"94158-14-2","citation":"Ref.: 31 3","dose":"this dose level were therefore considered to be due to the high maternal toxicity.","duration":"7 days","effect":"this dose level were therefore considered to be due to the high maternal toxicity. Similar, but less pronounced maternal and embryo/foetotoxicity were noted at the mid dose (250 mg/kg bw). The observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / C","endpoint":"","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":24,"route":"","species":"human","study_id":"sccp_o_044_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw | human | - | 7 days | - | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=50; DOSE=No effects were observed at the lowest dose level.; EFFECT=he observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in H; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"94158-14-2","citation":"Ref.: 31 3","dose":"No effects were observed at the lowest dose level.","duration":"7 days","effect":"he observed embryo-foetal effects were also considered to be related to the observed maternal toxicity. No effects were observed at the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in H","endpoint":"","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":24,"route":"","species":"human","study_id":"sccp_o_044_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =25.7 | mg/kg bw | human | - | 7 days | - | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 25.7; DOSE=the lowest dose level.; EFFECT=the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 120 min Number of experiments: two independent experiments GLP: not in compliance,; CITATION=Ref.: 31 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 3; DETAILS_JSON={"cas_number":"94158-14-2","citation":"Ref.: 31 3","dose":"the lowest dose level.","duration":"7 days","effect":"the lowest dose level. Based on these results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw was derived for maternal and for embryo-foetal effects. It should be noted that even if the NOAEL would be corrected for stability (based on the doubtful analytical data provided in the report), this would not have any influence on the risk assessment as the corrected value for the NOAEL (50 mg/kg bw multiplied with the percentage of the test item stable after 7 days (53%) = 25.7 mg/kg bw) still lies above the NOAEL observed in the 90 day study. Ref.: 31 3.3.9. Toxicokinetics 3.3.9. 1 Toxicokinetics in vitro Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: human intestinal epithelial cell line TC-7 Test substance: hydroxyethyl-3,4-methylenedioxyaniline HCl Batch: 9/93 Fass 195 Purity: 99.7 % (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 120 min Number of experiments: two independent experiments GLP: not in compliance,","endpoint":"","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 25.7","page":24,"route":"","species":"human","study_id":"sccp_o_044_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg | rabbit | oral | - | - | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; EFFECT=an Ratten; REPROTOX HUNTINGDON; 1981 - Osterburg, I.; 1-ß-Hydroxyethylamino-3,4-methylendioxybenzene oral (gavage) teratology study in the New Zealand White rabbit; HAZLETON; 1982 - Richold, M.; Micronucleus test on 1-ß-Hydroxyethylamino-3,4-methylenedioxybenzene dihydrochloride; HUNTINGDON; 1981 - Schoental, R.; Carcinogens in plants and microorganisms; ACS; 173, 626-648; 1976 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) zur Überprüfung eines NOAEL bei einer Dosierung von 20mg/kg Körpergewicht nach oraler Applikation an Ratten Appendix zu IBR Projekt 2-4- 280-81; IBR; 1982 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) mit anschließender 4-wöchiger Reversalzeit nach oraler Applikation an Ratten; IBR; 1982 - Weide, J.; Sensibilisierungstest am Albinomeerschweinchen mit 1-ß-Hydroxyethylamino- 3,4-methylendioxy-benzol; WELLA AG; 1985 - Wenker, M.A.M.; Absorption, distribution, metabolism and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"94158-14-2","citation":"","dose":"","duration":"","effect":"an Ratten; REPROTOX HUNTINGDON; 1981 - Osterburg, I.; 1-ß-Hydroxyethylamino-3,4-methylendioxybenzene oral (gavage) teratology study in the New Zealand White rabbit; HAZLETON; 1982 - Richold, M.; Micronucleus test on 1-ß-Hydroxyethylamino-3,4-methylenedioxybenzene dihydrochloride; HUNTINGDON; 1981 - Schoental, R.; Carcinogens in plants and microorganisms; ACS; 173, 626-648; 1976 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) zur Überprüfung eines NOAEL bei einer Dosierung von 20mg/kg Körpergewicht nach oraler Applikation an Ratten Appendix zu IBR Projekt 2-4- 280-81; IBR; 1982 - Sterner, W.; Korn, W.-D.; 3-monatige Toxizitätsprüfung mit 1-ß-Hydroxyethylamino-3,4- methylendioxybenzol (Aminol) mit anschließender 4-wöchiger Reversalzeit nach oraler Applikation an Ratten; IBR; 1982 - Weide, J.; Sensibilisierungstest am Albinomeerschweinchen mit 1-ß-Hydroxyethylamino- 3,4-methylendioxy-benzol; WELLA AG; 1985 - Wenker, M.A.M.; Absorption, distribution, metabolism and","endpoint":"","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"20","page":31,"route":"oral","species":"rabbit","study_id":"sccp_o_044_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | rat | - | 90 day | developmental toxicity | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern.; EFFECT=yaniline HCl is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability data on hydroxyethyl-3,4-methylenedioxyaniline HCl in Ref. 22 and Ref. 31 are contradictory; and stability of hdroxyethyl-3,4-methylenedioxyaniline HCl in the marketed products is not reported. 100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 20 mg/kg bw/day (90 day, rat). No NOAEL could be set for maternal and embryotoxicity as only the final draft report of the prenatal developmental toxicity in rats was available for evaluation. Irritation, sensitisation The substance is not irritant to guinea pig skin and mildly irritant to the eyes of guinea pig. It is a strong sensitiser. Percutaneous absorption Based on a conservative assumption that the total amount found in the skin will become bioavailable, an amount of 6.74 µg/cm² hydrox; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"94158-14-2","citation":"","dose":"100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern.","duration":"90 day","effect":"yaniline HCl is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability data on hydroxyethyl-3,4-methylenedioxyaniline HCl in Ref. 22 and Ref. 31 are contradictory; and stability of hdroxyethyl-3,4-methylenedioxyaniline HCl in the marketed products is not reported. 100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 20 mg/kg bw/day (90 day, rat). No NOAEL could be set for maternal and embryotoxicity as only the final draft report of the prenatal developmental toxicity in rats was available for evaluation. Irritation, sensitisation The substance is not irritant to guinea pig skin and mildly irritant to the eyes of guinea pig. It is a strong sensitiser. Percutaneous absorption Based on a conservative assumption that the total amount found in the skin will become bioavailable, an amount of 6.74 µg/cm² hydrox","endpoint":"developmental toxicity","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":28,"route":"","species":"rat","study_id":"sccp_o_044_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | rat | - | 90 day | developmental toxicity | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern.; EFFECT=and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability data on hydroxyethyl-3,4-methylenedioxyaniline HCl in Ref. 22 and Ref. 31 are contradictory; and stability of hdroxyethyl-3,4-methylenedioxyaniline HCl in the marketed products is not reported. 100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 20 mg/kg bw/day (90 day, rat). No NOAEL could be set for maternal and embryotoxicity as only the final draft report of the prenatal developmental toxicity in rats was available for evaluation. Irritation, sensitisation The substance is not irritant to guinea pig skin and mildly irritant to the eyes of guinea pig. It is a strong sensitiser. Percutaneous absorption Based on a conservative assumption that the total amount found in the skin will become bioavailable, an amount of 6.74 µg/cm² hydroxyethyl-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"94158-14-2","citation":"","dose":"100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern.","duration":"90 day","effect":"and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability data on hydroxyethyl-3,4-methylenedioxyaniline HCl in Ref. 22 and Ref. 31 are contradictory; and stability of hdroxyethyl-3,4-methylenedioxyaniline HCl in the marketed products is not reported. 100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 20 mg/kg bw/day (90 day, rat). No NOAEL could be set for maternal and embryotoxicity as only the final draft report of the prenatal developmental toxicity in rats was available for evaluation. Irritation, sensitisation The substance is not irritant to guinea pig skin and mildly irritant to the eyes of guinea pig. It is a strong sensitiser. Percutaneous absorption Based on a conservative assumption that the total amount found in the skin will become bioavailable, an amount of 6.74 µg/cm² hydroxyethyl-","endpoint":"developmental toxicity","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":28,"route":"","species":"rat","study_id":"sccp_o_044_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | rat | - | 90 day | developmental toxicity | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern.; EFFECT=ontent in the test material is not reported. Stability data on hydroxyethyl-3,4-methylenedioxyaniline HCl in Ref. 22 and Ref. 31 are contradictory; and stability of hdroxyethyl-3,4-methylenedioxyaniline HCl in the marketed products is not reported. 100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 20 mg/kg bw/day (90 day, rat). No NOAEL could be set for maternal and embryotoxicity as only the final draft report of the prenatal developmental toxicity in rats was available for evaluation. Irritation, sensitisation The substance is not irritant to guinea pig skin and mildly irritant to the eyes of guinea pig. It is a strong sensitiser. Percutaneous absorption Based on a conservative assumption that the total amount found in the skin will become bioavailable, an amount of 6.74 µg/cm² hydroxyethyl-3,5-methylenedioxyaniline HCl was calculated from th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"94158-14-2","citation":"","dose":"100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern.","duration":"90 day","effect":"ontent in the test material is not reported. Stability data on hydroxyethyl-3,4-methylenedioxyaniline HCl in Ref. 22 and Ref. 31 are contradictory; and stability of hdroxyethyl-3,4-methylenedioxyaniline HCl in the marketed products is not reported. 100-1100 ppm content of 3,4-(methylenedioxy)-aniline, which is an aromatic amine with a free amino group, in hydroxyethyl-3,4-methylenedioxyaniline HCl may be of concern. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 20 mg/kg bw/day (90 day, rat). No NOAEL could be set for maternal and embryotoxicity as only the final draft report of the prenatal developmental toxicity in rats was available for evaluation. Irritation, sensitisation The substance is not irritant to guinea pig skin and mildly irritant to the eyes of guinea pig. It is a strong sensitiser. Percutaneous absorption Based on a conservative assumption that the total amount found in the skin will become bioavailable, an amount of 6.74 µg/cm² hydroxyethyl-3,5-methylenedioxyaniline HCl was calculated from th","endpoint":"developmental toxicity","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":28,"route":"","species":"rat","study_id":"sccp_o_044_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 20 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_044; REPORT_TITLE=Opinion on Hydroxyethyl-3,4-methylenedioxyaniline HCl COLIPA N° A98; OPINION_NUMBER=SCCP/0951/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only).; EFFECT=r damage. In females extramedullary haematopoiesis was observed in the spleen and corpus luteum hypertrophy in the ovaries. In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only). Increased urinary volume was noted. Abs. and relative liver weights in males were increased, and hepatocellular hypertrophy was observed (most pronounced in males). At 20 mg/kg bw/day no adverse effects were observed. Conclusion The NOAEL in this study was 20 mg/kg bw/day. Ref.: 26 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Assay conditions: Plate incorporation and pre-incubation assay without and with S9 mix from rat livers (phenobarbital/ß-naphthoflavone induced). Three plates were investigated per test concentration; CITATION=Ref.: 26 3; CITATION_NUMBERS=[26,3]; REFERENCE=Ref.: 26 3; DETAILS_JSON={"cas_number":"94158-14-2","citation":"Ref.: 26 3","dose":"In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only).","duration":"Chronic","effect":"r damage. In females extramedullary haematopoiesis was observed in the spleen and corpus luteum hypertrophy in the ovaries. In the 100 mg/kg dose group increased bilirubin levels were noted in females, elevated cholesterol (both sexes) and phospholipids were observed (females only). Increased urinary volume was noted. Abs. and relative liver weights in males were increased, and hepatocellular hypertrophy was observed (most pronounced in males). At 20 mg/kg bw/day no adverse effects were observed. Conclusion The NOAEL in this study was 20 mg/kg bw/day. Ref.: 26 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Assay conditions: Plate incorporation and pre-incubation assay without and with S9 mix from rat livers (phenobarbital/ß-naphthoflavone induced). Three plates were investigated per test concentration","endpoint":"genotoxicity","ingredient":"Hydroxyethyl-3,4-methylenedioxyaniline HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":16,"route":"","species":"rat","study_id":"sccp_o_044_noael_001"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 8IRK9YBY3K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H11NO3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8IRK9YBY3K"} |
| openFDA substances | FDA UNII substance identifier | 8IRK9YBY3K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H11NO3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8IRK9YBY3K"} |
| openFDA substances | FDA UNII substance identifier | 8IRK9YBY3K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H11NO3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8IRK9YBY3K"} |
| openFDA substances | FDA UNII substance identifier | 8IRK9YBY3K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H11NO3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8IRK9YBY3K"} |