NOAEL Studies
Cosmetic Ingredient
1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate NOAEL Studies
INCI: 1-HYDROXYETHYL 4,5-DIAMINO PYRAZOLE SULFATE
CAS: 155601-30-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =250 | mg/ kg body weight/d | rat | oral | 9 wk | developmental toxicity | {"citation":"250; 19; 1","dose":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically.","effect":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically. No effects related to the test material were observed in the low-dose animals. There was a slight but statistically sig- nificant decreased in body weight gain in females of the high- dose group. High-dose males had slight changes in red blood cell parameters (increase in mean corpuscular hemoglobin and in red blood cell volume) and an increase in relative spleen weight. No further details were provided. The no observed adverse effect level (NOAEL) was determined to be 250 mg/ kg body weight/d.19 Reproductive and Developmental Toxicity The potential reproductive toxicity of 1-Hydroxyethyl 4,5- Diamino Pyrazole Sulfate in distilled water was investigated in a one-generation study in Sprague-Dawley rats.20 Three groups of 24 male and 24 female rats received 0, 150, 300, or 900 mg/kg body weight of the test material via gavage prior to mating (9 wk for males, 2 wk for females), during mating, and during gestation and lactation (females only until postnatal day 21). The control...","page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_001"} |
| CIR Safety Assessment | NOAEL | =300 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"nd violet staining was noted in the cage tray of all treated animals. Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_002"} |
| CIR Safety Assessment | NOAEL | =900 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic inspections of major organs and tissues were performed during gross n...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_003"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | developmental toxicity | {"citation":"300; 21; 1","dose":"of maternal toxicity noted at any dose level.","effect":"of maternal toxicity noted at any dose level. Fetal survival during prenatal development was not affected at any dose level. In the high dose group, marginal adverse effects in terms of slightly delayed ossification, ab- normal ossification patterns, and an increased incidence of fetuses with supernumerary ribs were observed. However, the distribution of sporadically observed malformations in all test groups and the controls did not indicate specific teratogenic effects of the test material. The maternal toxicity NOAEL was 1000 mg/kg body weight/day and the fetotoxicity NOAEL was 300 mg/kg body weight/day in this rat developmental study.21 Genotoxicity In Vitro In an Ames test, the mutagenic potential of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate was studied in Salmonella ty- phimurium strains TA98, TA100, TA1535, TA1537, and TA1538.22 The assay was performed with and without S9 metabolic activation at concentrations up to 5000 μg/plate. A reduction in revertant counts or sparse bacterial background lawn was observed in strains TA98 and TA1537 without S9 and in strains TA100 with...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_004"} |
| CIR Safety Assessment | NOAEL | =250 | - | Sprague Dawley rats | oral gavage | 13 weeks | NOAEL study | {"page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_1_repeated_dose_oral_13wk"} |
| CIR Safety Assessment | NOAEL | =300 | - | Sprague-Dawley rats | oral gavage | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_2_repro_parental"} |
| CIR Safety Assessment | NOAEL | =900 | - | Sprague-Dawley rats | oral gavage (maternal dosing) | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_3_repro_fetal"} |
| CIR Safety Assessment | NOAEL | =1000 | - | Sprague-Dawley rats | oral gavage | Gestation days 6-17 | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_4_developmental_maternal"} |
| CIR Safety Assessment | NOAEL | =250 | mg/ kg body weight/d | rat | oral | 9 wk | developmental toxicity | {"citation":"250; 19; 1","dose":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically.","effect":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically. No effects related to the test material were observed in the low-dose animals. There was a slight but statistically sig- nificant decreased in body weight gain in females of the high- dose group. High-dose males had slight changes in red blood cell parameters (increase in mean corpuscular hemoglobin and in red blood cell volume) and an increase in relative spleen weight. No further details were provided. The no observed adverse effect level (NOAEL) was determined to be 250 mg/ kg body weight/d.19 Reproductive and Developmental Toxicity The potential reproductive toxicity of 1-Hydroxyethyl 4,5- Diamino Pyrazole Sulfate in distilled water was investigated in a one-generation study in Sprague-Dawley rats.20 Three groups of 24 male and 24 female rats received 0, 150, 300, or 900 mg/kg body weight of the test material via gavage prior to mating (9 wk for males, 2 wk for females), during mating, and during gestation and lactation (females only until postnatal day 21). The control...","page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_001"} |
| CIR Safety Assessment | NOAEL | =300 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"nd violet staining was noted in the cage tray of all treated animals. Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_002"} |
| CIR Safety Assessment | NOAEL | =900 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic inspections of major organs and tissues were performed during gross n...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_003"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | developmental toxicity | {"citation":"300; 21; 1","dose":"of maternal toxicity noted at any dose level.","effect":"of maternal toxicity noted at any dose level. Fetal survival during prenatal development was not affected at any dose level. In the high dose group, marginal adverse effects in terms of slightly delayed ossification, ab- normal ossification patterns, and an increased incidence of fetuses with supernumerary ribs were observed. However, the distribution of sporadically observed malformations in all test groups and the controls did not indicate specific teratogenic effects of the test material. The maternal toxicity NOAEL was 1000 mg/kg body weight/day and the fetotoxicity NOAEL was 300 mg/kg body weight/day in this rat developmental study.21 Genotoxicity In Vitro In an Ames test, the mutagenic potential of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate was studied in Salmonella ty- phimurium strains TA98, TA100, TA1535, TA1537, and TA1538.22 The assay was performed with and without S9 metabolic activation at concentrations up to 5000 μg/plate. A reduction in revertant counts or sparse bacterial background lawn was observed in strains TA98 and TA1537 without S9 and in strains TA100 with...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_004"} |
| CIR Safety Assessment | NOAEL | =250 | - | Sprague Dawley rats | oral gavage | 13 weeks | NOAEL study | {"page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_1_repeated_dose_oral_13wk"} |
| CIR Safety Assessment | NOAEL | =300 | - | Sprague-Dawley rats | oral gavage | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_2_repro_parental"} |
| CIR Safety Assessment | NOAEL | =900 | - | Sprague-Dawley rats | oral gavage (maternal dosing) | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_3_repro_fetal"} |
| CIR Safety Assessment | NOAEL | =1000 | - | Sprague-Dawley rats | oral gavage | Gestation days 6-17 | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_4_developmental_maternal"} |
| CIR Safety Assessment | NOAEL | =250 | mg/ kg body weight/d | rat | oral | 9 wk | developmental toxicity | {"citation":"250; 19; 1","dose":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically.","effect":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically. No effects related to the test material were observed in the low-dose animals. There was a slight but statistically sig- nificant decreased in body weight gain in females of the high- dose group. High-dose males had slight changes in red blood cell parameters (increase in mean corpuscular hemoglobin and in red blood cell volume) and an increase in relative spleen weight. No further details were provided. The no observed adverse effect level (NOAEL) was determined to be 250 mg/ kg body weight/d.19 Reproductive and Developmental Toxicity The potential reproductive toxicity of 1-Hydroxyethyl 4,5- Diamino Pyrazole Sulfate in distilled water was investigated in a one-generation study in Sprague-Dawley rats.20 Three groups of 24 male and 24 female rats received 0, 150, 300, or 900 mg/kg body weight of the test material via gavage prior to mating (9 wk for males, 2 wk for females), during mating, and during gestation and lactation (females only until postnatal day 21). The control...","page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_001"} |
| CIR Safety Assessment | NOAEL | =300 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"nd violet staining was noted in the cage tray of all treated animals. Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_002"} |
| CIR Safety Assessment | NOAEL | =900 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic inspections of major organs and tissues were performed during gross n...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_003"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | developmental toxicity | {"citation":"300; 21; 1","dose":"of maternal toxicity noted at any dose level.","effect":"of maternal toxicity noted at any dose level. Fetal survival during prenatal development was not affected at any dose level. In the high dose group, marginal adverse effects in terms of slightly delayed ossification, ab- normal ossification patterns, and an increased incidence of fetuses with supernumerary ribs were observed. However, the distribution of sporadically observed malformations in all test groups and the controls did not indicate specific teratogenic effects of the test material. The maternal toxicity NOAEL was 1000 mg/kg body weight/day and the fetotoxicity NOAEL was 300 mg/kg body weight/day in this rat developmental study.21 Genotoxicity In Vitro In an Ames test, the mutagenic potential of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate was studied in Salmonella ty- phimurium strains TA98, TA100, TA1535, TA1537, and TA1538.22 The assay was performed with and without S9 metabolic activation at concentrations up to 5000 μg/plate. A reduction in revertant counts or sparse bacterial background lawn was observed in strains TA98 and TA1537 without S9 and in strains TA100 with...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_004"} |
| CIR Safety Assessment | NOAEL | =250 | - | Sprague Dawley rats | oral gavage | 13 weeks | NOAEL study | {"page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_1_repeated_dose_oral_13wk"} |
| CIR Safety Assessment | NOAEL | =300 | - | Sprague-Dawley rats | oral gavage | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_2_repro_parental"} |
| CIR Safety Assessment | NOAEL | =900 | - | Sprague-Dawley rats | oral gavage (maternal dosing) | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_3_repro_fetal"} |
| CIR Safety Assessment | NOAEL | =1000 | - | Sprague-Dawley rats | oral gavage | Gestation days 6-17 | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_4_developmental_maternal"} |
| CIR Safety Assessment | NOAEL | =250 | mg/ kg body weight/d | rat | oral | 9 wk | developmental toxicity | {"citation":"250; 19; 1","dose":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically.","effect":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically. No effects related to the test material were observed in the low-dose animals. There was a slight but statistically sig- nificant decreased in body weight gain in females of the high- dose group. High-dose males had slight changes in red blood cell parameters (increase in mean corpuscular hemoglobin and in red blood cell volume) and an increase in relative spleen weight. No further details were provided. The no observed adverse effect level (NOAEL) was determined to be 250 mg/ kg body weight/d.19 Reproductive and Developmental Toxicity The potential reproductive toxicity of 1-Hydroxyethyl 4,5- Diamino Pyrazole Sulfate in distilled water was investigated in a one-generation study in Sprague-Dawley rats.20 Three groups of 24 male and 24 female rats received 0, 150, 300, or 900 mg/kg body weight of the test material via gavage prior to mating (9 wk for males, 2 wk for females), during mating, and during gestation and lactation (females only until postnatal day 21). The control...","page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_001"} |
| CIR Safety Assessment | NOAEL | =300 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"nd violet staining was noted in the cage tray of all treated animals. Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_002"} |
| CIR Safety Assessment | NOAEL | =900 | mg/kg body weight/d | rat | oral | - | developmental toxicity | {"citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","effect":"Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic inspections of major organs and tissues were performed during gross n...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_003"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | developmental toxicity | {"citation":"300; 21; 1","dose":"of maternal toxicity noted at any dose level.","effect":"of maternal toxicity noted at any dose level. Fetal survival during prenatal development was not affected at any dose level. In the high dose group, marginal adverse effects in terms of slightly delayed ossification, ab- normal ossification patterns, and an increased incidence of fetuses with supernumerary ribs were observed. However, the distribution of sporadically observed malformations in all test groups and the controls did not indicate specific teratogenic effects of the test material. The maternal toxicity NOAEL was 1000 mg/kg body weight/day and the fetotoxicity NOAEL was 300 mg/kg body weight/day in this rat developmental study.21 Genotoxicity In Vitro In an Ames test, the mutagenic potential of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate was studied in Salmonella ty- phimurium strains TA98, TA100, TA1535, TA1537, and TA1538.22 The assay was performed with and without S9 metabolic activation at concentrations up to 5000 μg/plate. A reduction in revertant counts or sparse bacterial background lawn was observed in strains TA98 and TA1537 without S9 and in strains TA100 with...","page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"PRS705_noael_004"} |
| CIR Safety Assessment | NOAEL | =250 | - | Sprague Dawley rats | oral gavage | 13 weeks | NOAEL study | {"page":5,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_1_repeated_dose_oral_13wk"} |
| CIR Safety Assessment | NOAEL | =300 | - | Sprague-Dawley rats | oral gavage | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_2_repro_parental"} |
| CIR Safety Assessment | NOAEL | =900 | - | Sprague-Dawley rats | oral gavage (maternal dosing) | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_3_repro_fetal"} |
| CIR Safety Assessment | NOAEL | =1000 | - | Sprague-Dawley rats | oral gavage | Gestation days 6-17 | NOAEL study | {"page":6,"pdf":"PRS705.pdf","row_type":"noael_study","study_id":"noael_4_developmental_maternal"} |
COSMOS DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 800 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCP; Brightwell, J.; DA 010894 13 week oral toxicity study in rats; RTC; 1999 |
| COSMOS DB | NOAEL | 250 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCP; Brightwell, J.; DA 010894 13 week oral toxicity study in rats; RTC; 1999 |
NTP ICE acute oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | >2000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_3067; row=3668; data_type=In Vivo; mixture=Chemical; chemical_name=4,5-Diamino-1-(2-hydroxyethyl)pyrazole sulfate; preferred_name=4,5-Diamino-1-(2-hydroxyethyl)pyrazole sulfate; dtxsid=DTXSID20165928; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID20165928; source_file=acute_oral.xlsx |
SCCS Opinion 52 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0.02 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"yrazole sulfate ___________________________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aer","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_006"} |
| SCCS Opinion | NOAEL | =0.02 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"yrazole sulfate ___________________________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aer","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_006"} |
| SCCS Opinion | NOAEL | =0.02 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"yrazole sulfate ___________________________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aer","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_006"} |
| SCCS Opinion | NOAEL | =0.02 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"yrazole sulfate ___________________________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aer","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_006"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | genotoxicity | {"citation":"Ref.: 17 3","dose":"ut statistically significant decreased in females from the 800 mg/kg dose group.","effect":"ut statistically significant decreased in females from the 800 mg/kg dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 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 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Two independent tests with and without S9 mix (in triplicate) Test substance: DA 010894 Vehicle: water Batch: 4-20079 Purity: > 99% (HPLC) Concentrations: 1-5000 µg/plate with and without S9","page":14,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | NOAEL study | {"citation":"Ref.: 17 3","dose":"statistically significant decreased in females from the 800 mg/kg bw dose group.","effect":"statistically significant decreased in females from the 800 mg/kg bw dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"__________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol o","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_007"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | genotoxicity | {"citation":"Ref.: 17 3","dose":"ut statistically significant decreased in females from the 800 mg/kg dose group.","effect":"ut statistically significant decreased in females from the 800 mg/kg dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 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 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Two independent tests with and without S9 mix (in triplicate) Test substance: DA 010894 Vehicle: water Batch: 4-20079 Purity: > 99% (HPLC) Concentrations: 1-5000 µg/plate with and without S9","page":14,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | genotoxicity | {"citation":"Ref.: 17 3","dose":"ut statistically significant decreased in females from the 800 mg/kg dose group.","effect":"ut statistically significant decreased in females from the 800 mg/kg dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 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 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Two independent tests with and without S9 mix (in triplicate) Test substance: DA 010894 Vehicle: water Batch: 4-20079 Purity: > 99% (HPLC) Concentrations: 1-5000 µg/plate with and without S9","page":14,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | NOAEL study | {"citation":"Ref.: 17 3","dose":"statistically significant decreased in females from the 800 mg/kg bw dose group.","effect":"statistically significant decreased in females from the 800 mg/kg bw dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"__________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol o","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_007"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | NOAEL study | {"citation":"Ref.: 17 3","dose":"statistically significant decreased in females from the 800 mg/kg bw dose group.","effect":"statistically significant decreased in females from the 800 mg/kg bw dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"__________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol o","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_007"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | genotoxicity | {"citation":"Ref.: 17 3","dose":"ut statistically significant decreased in females from the 800 mg/kg dose group.","effect":"ut statistically significant decreased in females from the 800 mg/kg dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 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 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Two independent tests with and without S9 mix (in triplicate) Test substance: DA 010894 Vehicle: water Batch: 4-20079 Purity: > 99% (HPLC) Concentrations: 1-5000 µg/plate with and without S9","page":14,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | - | - | 13-week | NOAEL study | {"citation":"Ref.: 17 3","dose":"statistically significant decreased in females from the 800 mg/kg bw dose group.","effect":"statistically significant decreased in females from the 800 mg/kg bw dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_001"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"__________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol o","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_007"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | - | - | - | developmental toxicity | {"citation":"Ref.: 23","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg | rat | oral | 13-week | reproductive toxicity | {"dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ormulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact alle","page":23,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_007"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | rat | oral | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (four groups) per dose 6 Females in the toxicokinetics groups (four groups) per dose Test substance: WR 18247 Vehicle: Milli-Q (oral and dermal dosing) and 0.9% saline (intravenous dosing); solutions contained 0.3% sodium sulphite and were adjusted to pH 7-8 with ammonia 25%","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw/ day | rat | oral | 13-week | reproductive toxicity | {"dose":"The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokineti","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_009"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | - | - | - | developmental toxicity | {"citation":"Ref.: 23","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg | rat | oral | 13-week | reproductive toxicity | {"dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ormulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact alle","page":23,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_007"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | - | - | - | developmental toxicity | {"citation":"Ref.: 23","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg | rat | oral | 13-week | reproductive toxicity | {"dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ormulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact alle","page":23,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_007"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | rat | oral | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (four groups) per dose 6 Females in the toxicokinetics groups (four groups) per dose Test substance: WR 18247 Vehicle: Milli-Q (oral and dermal dosing) and 0.9% saline (intravenous dosing); solutions contained 0.3% sodium sulphite and were adjusted to pH 7-8 with ammonia 25%","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw/ day | rat | oral | 13-week | reproductive toxicity | {"dose":"The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokineti","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_009"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | rat | oral | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (four groups) per dose 6 Females in the toxicokinetics groups (four groups) per dose Test substance: WR 18247 Vehicle: Milli-Q (oral and dermal dosing) and 0.9% saline (intravenous dosing); solutions contained 0.3% sodium sulphite and were adjusted to pH 7-8 with ammonia 25%","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw/ day | rat | oral | 13-week | reproductive toxicity | {"dose":"The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokineti","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_009"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | - | - | - | developmental toxicity | {"citation":"Ref.: 23","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg | rat | oral | 13-week | reproductive toxicity | {"dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ormulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact alle","page":23,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_007"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw | rat | oral | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (four groups) per dose 6 Females in the toxicokinetics groups (four groups) per dose Test substance: WR 18247 Vehicle: Milli-Q (oral and dermal dosing) and 0.9% saline (intravenous dosing); solutions contained 0.3% sodium sulphite and were adjusted to pH 7-8 with ammonia 25%","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_005"} |
| SCCS Opinion | NOAEL | =300 | mg/kg bw/ day | rat | oral | 13-week | reproductive toxicity | {"dose":"The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","effect":"ico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokineti","page":27,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_009"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | - | - | prenatal | reproductive toxicity | {"dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight","page":18,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg/day | rat | - | - | NOAEL study | {"citation":"Ref.: 24 3","dose":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day.","effect":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day. Ref.: 24 3.3.8.2. Teratogenicity Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 300 or 1000 mg/kg bw of the","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_003"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | rat | - | prenatal | reproductive toxicity | {"citation":"Ref.: 24 3","dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclu","page":23,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | - | - | prenatal | reproductive toxicity | {"dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight","page":18,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg/day | rat | - | - | NOAEL study | {"citation":"Ref.: 24 3","dose":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day.","effect":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day. Ref.: 24 3.3.8.2. Teratogenicity Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 300 or 1000 mg/kg bw of the","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_003"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | - | - | prenatal | reproductive toxicity | {"dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight","page":18,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg/day | rat | - | - | NOAEL study | {"citation":"Ref.: 24 3","dose":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day.","effect":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day. Ref.: 24 3.3.8.2. Teratogenicity Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 300 or 1000 mg/kg bw of the","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_003"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | rat | - | prenatal | reproductive toxicity | {"citation":"Ref.: 24 3","dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclu","page":23,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | rat | - | prenatal | reproductive toxicity | {"citation":"Ref.: 24 3","dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclu","page":23,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | - | - | prenatal | reproductive toxicity | {"dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight","page":18,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_002"} |
| SCCS Opinion | NOAEL | =900 | mg/kg/day | rat | - | - | NOAEL study | {"citation":"Ref.: 24 3","dose":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day.","effect":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day. Ref.: 24 3.3.8.2. Teratogenicity Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 300 or 1000 mg/kg bw of the","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_003"} |
| SCCS Opinion | NOAEL | =900 | mg/kg bw | rat | - | prenatal | reproductive toxicity | {"citation":"Ref.: 24 3","dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclu","page":23,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_002"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | - | - | prenatal | developmental toxicity | {"citation":"Ref.: 23","dose":"Survival of the foetuses during prenatal development was not affected at any dose level.","effect":"dosages. Survival of the foetuses during prenatal development was not affected at any dose level. At the high dose of 1000 mg/kg bw, marginal adverse effects of the test compound were evident as indicated by a slightly delayed ossification, abnormal ossification patterns and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | - | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"SCCS/1449/11 Opinion on 1-Hydroxyethyl-4,5-diamino pyrazole sulfate ___________________________________________________________________________________________ 24 and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (fou","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | - | - | prenatal | developmental toxicity | {"citation":"Ref.: 23","dose":"Survival of the foetuses during prenatal development was not affected at any dose level.","effect":"dosages. Survival of the foetuses during prenatal development was not affected at any dose level. At the high dose of 1000 mg/kg bw, marginal adverse effects of the test compound were evident as indicated by a slightly delayed ossification, abnormal ossification patterns and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | - | - | prenatal | developmental toxicity | {"citation":"Ref.: 23","dose":"Survival of the foetuses during prenatal development was not affected at any dose level.","effect":"dosages. Survival of the foetuses during prenatal development was not affected at any dose level. At the high dose of 1000 mg/kg bw, marginal adverse effects of the test compound were evident as indicated by a slightly delayed ossification, abnormal ossification patterns and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | - | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"SCCS/1449/11 Opinion on 1-Hydroxyethyl-4,5-diamino pyrazole sulfate ___________________________________________________________________________________________ 24 and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (fou","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | - | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"SCCS/1449/11 Opinion on 1-Hydroxyethyl-4,5-diamino pyrazole sulfate ___________________________________________________________________________________________ 24 and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (fou","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | - | - | prenatal | developmental toxicity | {"citation":"Ref.: 23","dose":"Survival of the foetuses during prenatal development was not affected at any dose level.","effect":"dosages. Survival of the foetuses during prenatal development was not affected at any dose level. At the high dose of 1000 mg/kg bw, marginal adverse effects of the test compound were evident as indicated by a slightly delayed ossification, abnormal ossification patterns and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","page":19,"pdf":"sccp_o_064.pdf","row_type":"noael_study","study_id":"sccp_o_064_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | - | - | developmental toxicity | {"citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","effect":"SCCS/1449/11 Opinion on 1-Hydroxyethyl-4,5-diamino pyrazole sulfate ___________________________________________________________________________________________ 24 and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (fou","page":24,"pdf":"sccs_o_079.pdf","row_type":"noael_study","study_id":"sccs_o_079_noael_004"} |
Regulatory source 30 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 250 | - | Sprague Dawley rats | oral gavage | 13 weeks | - | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=250 mg/kg body weight/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"","duration":"13 weeks","effect":"","endpoint":"","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"","noael_value":"250 mg/kg body weight/d","page":5,"route":"oral gavage","species":"Sprague Dawley rats","study_id":"noael_1_repeated_dose_oral_13wk"} |
| Regulatory source | - | 300 | - | Sprague-Dawley rats | oral gavage | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | - | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=300 mg/kg body weight/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"","duration":"9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21)","effect":"","endpoint":"","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"","noael_value":"300 mg/kg body weight/d","page":6,"route":"oral gavage","species":"Sprague-Dawley rats","study_id":"noael_2_repro_parental"} |
| Regulatory source | - | 900 | - | Sprague-Dawley rats | oral gavage (maternal dosing) | 9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21) | - | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=900 mg/kg body weight/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"","duration":"9 weeks (males premating), 2 weeks (females premating), through mating, gestation, and lactation (females to postnatal day 21)","effect":"","endpoint":"","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"","noael_value":"900 mg/kg body weight/d","page":6,"route":"oral gavage (maternal dosing)","species":"Sprague-Dawley rats","study_id":"noael_3_repro_fetal"} |
| Regulatory source | - | 1000 | - | Sprague-Dawley rats | oral gavage | Gestation days 6-17 | - | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=1000 mg/kg body weight/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"","duration":"Gestation days 6-17","effect":"","endpoint":"","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"","noael_value":"1000 mg/kg body weight/day","page":6,"route":"oral gavage","species":"Sprague-Dawley rats","study_id":"noael_4_developmental_maternal"} |
| Regulatory source | - | 300 | - | Sprague-Dawley rats | oral gavage (maternal dosing) | Gestation days 6-17 | - | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=300 mg/kg body weight/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"","duration":"Gestation days 6-17","effect":"","endpoint":"","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"","noael_value":"300 mg/kg body weight/day","page":6,"route":"oral gavage (maternal dosing)","species":"Sprague-Dawley rats","study_id":"noael_5_developmental_fetal"} |
| Regulatory source | developmental toxicity | 250 | mg/ kg body weight/d | rat | oral | 9 wk | developmental toxicity | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=250; DOSE=d from all animals, but only specimens from the control and high-dose groups were examined microscopically.; EFFECT=d from all animals, but only specimens from the control and high-dose groups were examined microscopically. No effects related to the test material were observed in the low-dose animals. There was a slight but statistically sig- nificant decreased in body weight gain in females of the high- dose group. High-dose males had slight changes in red blood cell parameters (increase in mean corpuscular hemoglobin and in red blood cell volume) and an increase in relative spleen weight. No further details were provided. The no observed adverse effect level (NOAEL) was determined to be 250 mg/ kg body weight/d.19 Reproductive and Developmental Toxicity The potential reproductive toxicity of 1-Hydroxyethyl 4,5- Diamino Pyrazole Sulfate in distilled water was investigated in a one-generation study in Sprague-Dawley rats.20 Three groups of 24 male and 24 female rats received 0, 150, 300, or 900 mg/kg body weight of the test material via gavage prior to mating (9 wk for males, 2 wk for females), during mating, and during gestation and lactation (females only until postnatal day 21). The control...; CITATION=250; 19; 1; CITATION_NUMBERS=[250,19,1]; REFERENCE=250; 19; 1; DETAILS_JSON={"cas_number":"155601-30-2","citation":"250; 19; 1","dose":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically.","duration":"9 wk","effect":"d from all animals, but only specimens from the control and high-dose groups were examined microscopically. No effects related to the test material were observed in the low-dose animals. There was a slight but statistically sig- nificant decreased in body weight gain in females of the high- dose group. High-dose males had slight changes in red blood cell parameters (increase in mean corpuscular hemoglobin and in red blood cell volume) and an increase in relative spleen weight. No further details were provided. The no observed adverse effect level (NOAEL) was determined to be 250 mg/ kg body weight/d.19 Reproductive and Developmental Toxicity The potential reproductive toxicity of 1-Hydroxyethyl 4,5- Diamino Pyrazole Sulfate in distilled water was investigated in a one-generation study in Sprague-Dawley rats.20 Three groups of 24 male and 24 female rats received 0, 150, 300, or 900 mg/kg body weight of the test material via gavage prior to mating (9 wk for males, 2 wk for females), during mating, and during gestation and lactation (females only until postnatal day 21). The control...","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"mg/ kg body weight/d","noael_value":"250","page":5,"route":"oral","species":"rat","study_id":"PRS705_noael_001"} |
| Regulatory source | developmental toxicity | 300 | mg/kg body weight/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=300; DOSE=Red staining on the dorsum was noted in pups of the mid- and high dose groups.; EFFECT=nd violet staining was noted in the cage tray of all treated animals. Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic...; CITATION=300; 900; 20; CITATION_NUMBERS=[300,900,20]; REFERENCE=300; 900; 20; DETAILS_JSON={"cas_number":"155601-30-2","citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","duration":"","effect":"nd violet staining was noted in the cage tray of all treated animals. Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic...","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"300","page":6,"route":"oral","species":"rat","study_id":"PRS705_noael_002"} |
| Regulatory source | developmental toxicity | 900 | mg/kg body weight/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=900; DOSE=Red staining on the dorsum was noted in pups of the mid- and high dose groups.; EFFECT=Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic inspections of major organs and tissues were performed during gross n...; CITATION=300; 900; 20; CITATION_NUMBERS=[300,900,20]; REFERENCE=300; 900; 20; DETAILS_JSON={"cas_number":"155601-30-2","citation":"300; 900; 20","dose":"Red staining on the dorsum was noted in pups of the mid- and high dose groups.","duration":"","effect":"Reproductive parameters, litter data, sex ratios, gestation, and pre- weaning development of the pups were not affected by treatment. Red staining on the dorsum was noted in pups of the mid- and high dose groups. At necropsy, a decrease in testes weight and an increase in spleen weight were noted in high dose parental animals when compared to controls. No treatment-related effects were observed during macroscopic or microscopic examinations. The NOAEL for parental animals was 300 mg/kg body weight/d and the fetal NOAEL was 900 mg/kg body weight/d.20 In a developmental study, mated female Sprague-Dawley rats received 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate by gavage on days 6–17 of gestation.21 Groups of 24 rats received 0, 100, 300, or 1000 mg/kg body weight of the test material in distilled water. Maternal clinical signs were monitored daily. Body weights were recorded on days 0, 2, 4, 6 through 17, and on day 20, and feed consumption was measured on day 20. Dams were killed on gestation day 20. Macroscopic inspections of major organs and tissues were performed during gross n...","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"900","page":6,"route":"oral","species":"rat","study_id":"PRS705_noael_003"} |
| Regulatory source | developmental toxicity | 1000 | mg/kg body weight/day | rat | - | - | developmental toxicity | SOURCE_SUBDIR=PRS705; REPORT_TITLE=Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics; OPINION_NUMBER=PRS705; COMMITTEE=Safe in the present practices of use and concentration in oxidative hair dye formulations; REPORT_DATE=2022; VALUE_TEXT=1000; DOSE=of maternal toxicity noted at any dose level.; EFFECT=of maternal toxicity noted at any dose level. Fetal survival during prenatal development was not affected at any dose level. In the high dose group, marginal adverse effects in terms of slightly delayed ossification, ab- normal ossification patterns, and an increased incidence of fetuses with supernumerary ribs were observed. However, the distribution of sporadically observed malformations in all test groups and the controls did not indicate specific teratogenic effects of the test material. The maternal toxicity NOAEL was 1000 mg/kg body weight/day and the fetotoxicity NOAEL was 300 mg/kg body weight/day in this rat developmental study.21 Genotoxicity In Vitro In an Ames test, the mutagenic potential of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate was studied in Salmonella ty- phimurium strains TA98, TA100, TA1535, TA1537, and TA1538.22 The assay was performed with and without S9 metabolic activation at concentrations up to 5000 μg/plate. A reduction in revertant counts or sparse bacterial background lawn was observed in strains TA98 and TA1537 without S9 and in strains TA100 with...; CITATION=300; 21; 1; CITATION_NUMBERS=[300,21,1]; REFERENCE=300; 21; 1; DETAILS_JSON={"cas_number":"155601-30-2","citation":"300; 21; 1","dose":"of maternal toxicity noted at any dose level.","duration":"","effect":"of maternal toxicity noted at any dose level. Fetal survival during prenatal development was not affected at any dose level. In the high dose group, marginal adverse effects in terms of slightly delayed ossification, ab- normal ossification patterns, and an increased incidence of fetuses with supernumerary ribs were observed. However, the distribution of sporadically observed malformations in all test groups and the controls did not indicate specific teratogenic effects of the test material. The maternal toxicity NOAEL was 1000 mg/kg body weight/day and the fetotoxicity NOAEL was 300 mg/kg body weight/day in this rat developmental study.21 Genotoxicity In Vitro In an Ames test, the mutagenic potential of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate was studied in Salmonella ty- phimurium strains TA98, TA100, TA1535, TA1537, and TA1538.22 The assay was performed with and without S9 metabolic activation at concentrations up to 5000 μg/plate. A reduction in revertant counts or sparse bacterial background lawn was observed in strains TA98 and TA1537 without S9 and in strains TA100 with...","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate","loael_value":"","noael_unit":"mg/kg body weight/day","noael_value":"1000","page":6,"route":"","species":"rat","study_id":"PRS705_noael_004"} |
| Regulatory source | - | 250 | mg/kg bw/day | - | - | 13-week | - | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=250; DOSE=statistically significant decreased in females from the 800 mg/kg bw dose group.; EFFECT=statistically significant decreased in females from the 800 mg/kg bw dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 17 3","dose":"statistically significant decreased in females from the 800 mg/kg bw dose group.","duration":"13-week","effect":"statistically significant decreased in females from the 800 mg/kg bw dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":17,"route":"","species":"","study_id":"sccs_o_079_noael_001"} |
| Regulatory source | - | 900 | mg/kg/day | rat | - | - | - | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=900; DOSE=SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day.; EFFECT=SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day. Ref.: 24 3.3.8.2. Teratogenicity Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 300 or 1000 mg/kg bw of the; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 24 3","dose":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day.","duration":"","effect":"SCCP/0990/06 Opinion on 1-hydroxyethyl-4,5-diamino Pyrazole Sulfate ____________________________________________________________________________________________ 19 in the high dose group (900 mg/kg/day) the NOAEL for parental males and females is 300 mg/kg/bw day. Ref.: 24 3.3.8.2. Teratogenicity Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 300 or 1000 mg/kg bw of the","endpoint":"","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"900","page":19,"route":"","species":"rat","study_id":"sccp_o_064_noael_003"} |
| Regulatory source | dermal absorption | =0.02 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT== 0.02; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=yrazole sulfate ___________________________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aer; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"13-week","effect":"yrazole sulfate ___________________________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aer","endpoint":"dermal absorption","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.02","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_006"} |
| Regulatory source | dermal absorption | =250 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT== 250; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=__________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"13-week","effect":"__________________________________________________________________________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol o","endpoint":"dermal absorption","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 250","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_007"} |
| Regulatory source | dermal absorption | =250 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT== 250; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=____________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"13-week","effect":"____________ 27 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1-Hydroxyethyl-4,5-diamino pyrazole sulfate Oxidative conditions Absorption through the skin A = 1.953 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.132 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 250 mg/kg bw/d (13-week oral study, rat, gavage) MOS NOAEL/SED = 12500 3.3.14. Discussion Physico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes.","endpoint":"dermal absorption","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 250","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_008"} |
| Regulatory source | developmental toxicity | 300 | mg/kg bw | - | - | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=300; DOSE=Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.; EFFECT=nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23; CITATION=Ref.: 23; CITATION_NUMBERS=[23]; REFERENCE=Ref.: 23; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 23","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","duration":"","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":19,"route":"","species":"","study_id":"sccp_o_064_noael_005"} |
| Regulatory source | developmental toxicity | 300 | mg/kg bw | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=300; DOSE=Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.; EFFECT=nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (four groups) per dose 6 Females in the toxicokinetics groups (four groups) per dose Test substance: WR 18247 Vehicle: Milli-Q (oral and dermal dosing) and 0.9% saline (intravenous dosing); solutions contained 0.3% sodium sulphite and were adjusted to pH 7-8 with ammonia 25%; CITATION=Ref.: 23 3; CITATION_NUMBERS=[23,3]; REFERENCE=Ref.: 23 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","duration":"","effect":"nd an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (four groups) per dose 6 Females in the toxicokinetics groups (four groups) per dose Test substance: WR 18247 Vehicle: Milli-Q (oral and dermal dosing) and 0.9% saline (intravenous dosing); solutions contained 0.3% sodium sulphite and were adjusted to pH 7-8 with ammonia 25%","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":24,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_005"} |
| Regulatory source | developmental toxicity | 1000 | mg/kg bw/day | - | - | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=1000; DOSE=Survival of the foetuses during prenatal development was not affected at any dose level.; EFFECT=dosages. Survival of the foetuses during prenatal development was not affected at any dose level. At the high dose of 1000 mg/kg bw, marginal adverse effects of the test compound were evident as indicated by a slightly delayed ossification, abnormal ossification patterns and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23; CITATION=Ref.: 23; CITATION_NUMBERS=[23]; REFERENCE=Ref.: 23; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 23","dose":"Survival of the foetuses during prenatal development was not affected at any dose level.","duration":"prenatal","effect":"dosages. Survival of the foetuses during prenatal development was not affected at any dose level. At the high dose of 1000 mg/kg bw, marginal adverse effects of the test compound were evident as indicated by a slightly delayed ossification, abnormal ossification patterns and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":19,"route":"","species":"","study_id":"sccp_o_064_noael_004"} |
| Regulatory source | developmental toxicity | 1000 | mg/kg bw/day | rat | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=1000; DOSE=Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.; EFFECT=SCCS/1449/11 Opinion on 1-Hydroxyethyl-4,5-diamino pyrazole sulfate ___________________________________________________________________________________________ 24 and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (fou; CITATION=Ref.: 23 3; CITATION_NUMBERS=[23,3]; REFERENCE=Ref.: 23 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 23 3","dose":"Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day.","duration":"","effect":"SCCS/1449/11 Opinion on 1-Hydroxyethyl-4,5-diamino pyrazole sulfate ___________________________________________________________________________________________ 24 and an increased incidence of foetuses with supernumerary ribs. The distribution of sporadically observed malformations over all study groups including controls did not indicate a specific teratogenic activity of the test compound. Conclusion The NOAEL for maternal toxicity was 1000 mg/kg bw/day. The highest dose of 1000 mg/kg bw exerted slight embryotoxic effects manifested as delayed or disturbed ossification and increased occurrence of supernumerary ribs. The intermediate dosage of 300 mg/kg bw was found as the NOAEL for foetotoxicity. Ref.: 23 3.3.9. Toxicokinetics Taken from SCCP/0990/06 Guideline: OECD 417 (1984); OECD 427 (draft, 2000) Species/strain: Rat, strain Wistar Kyoto, WKY/NR Crl BR (inbred) Group size: 4 Females in the mass balance groups (fou","endpoint":"developmental toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":24,"route":"","species":"rat","study_id":"sccs_o_079_noael_004"} |
| Regulatory source | genotoxicity | 250 | mg/kg bw/day | - | - | 13-week | genotoxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=250; DOSE=ut statistically significant decreased in females from the 800 mg/kg dose group.; EFFECT=ut statistically significant decreased in females from the 800 mg/kg dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 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 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Two independent tests with and without S9 mix (in triplicate) Test substance: DA 010894 Vehicle: water Batch: 4-20079 Purity: > 99% (HPLC) Concentrations: 1-5000 µg/plate with and without S9; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 17 3","dose":"ut statistically significant decreased in females from the 800 mg/kg dose group.","duration":"13-week","effect":"ut statistically significant decreased in females from the 800 mg/kg dose group. In high dose males, slight changes in red blood cell parameters (increase in mean corpuscular haemoglobin and in red blood cell volume) and an increase in relative spleen weight was observed. Conclusion In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Ref.: 17 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 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Two independent tests with and without S9 mix (in triplicate) Test substance: DA 010894 Vehicle: water Batch: 4-20079 Purity: > 99% (HPLC) Concentrations: 1-5000 µg/plate with and without S9","endpoint":"genotoxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":14,"route":"","species":"","study_id":"sccp_o_064_noael_001"} |
| Regulatory source | reproductive toxicity | 250 | mg/kg bw/day | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=250; DOSE=General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=ydroxyethyl-4,5-diamino pyrazole sulphate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious dam; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"ydroxyethyl-4,5-diamino pyrazole sulphate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious dam","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_064_noael_006"} |
| Regulatory source | reproductive toxicity | 250 | mg/kg bw/day | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=250; DOSE=In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day.; EFFECT=both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokinetics Absorption, distribution, metabolism and excretion have been investigated in the female Wistar Kyoto rat, a strain with a low acetylator phenotype. After oral administration, 14C-1- Hydroxyethyl-4,5-Diamino Pyrazole Sulfate was extensively absorbed, readily distributed into all organs, extensively metabolised and excreted via the urine and faeces. The oral absorption of 14C-1-Hydroxyethyl-4,5-Diamino Pyrazole Sulfate was high, between 78-83%. Dermal absorption o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day.","duration":"13-week","effect":"both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokinetics Absorption, distribution, metabolism and excretion have been investigated in the female Wistar Kyoto rat, a strain with a low acetylator phenotype. After oral administration, 14C-1- Hydroxyethyl-4,5-Diamino Pyrazole Sulfate was extensively absorbed, readily distributed into all organs, extensively metabolised and excreted via the urine and faeces. The oral absorption of 14C-1-Hydroxyethyl-4,5-Diamino Pyrazole Sulfate was high, between 78-83%. Dermal absorption o","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_012"} |
| Regulatory source | reproductive toxicity | 300 | mg/kg | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=300; DOSE=General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=ormulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact alle; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"ormulations at a final concentration of 3%, after mixing with peroxide. The EINECS or ELINCS number is not provided. The stability of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact alle","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":23,"route":"oral","species":"rat","study_id":"sccp_o_064_noael_007"} |
| Regulatory source | reproductive toxicity | 300 | mg/kg bw | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=300; DOSE=General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=eted products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact allergen in a Magnusson and Kligman test. In a Buehler test, the substance showed no sensitising potential when applied epicutaneously at a concentration of 40 %. Dermal absorption Under the described test condi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"eted products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact allergen in a Magnusson and Kligman test. In a Buehler test, the substance showed no sensitising potential when applied epicutaneously at a concentration of 40 %. Dermal absorption Under the described test condi","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":23,"route":"oral","species":"rat","study_id":"sccp_o_064_noael_009"} |
| Regulatory source | reproductive toxicity | 300 | mg/kg bw/ day | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=300; DOSE=The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=ico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokineti; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"ico-chemical specifications 1-Hydroxyethyl-4,5-diamino pyrazole sulfate is used in oxidative hair dye formulations at a final concentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokineti","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/ day","noael_value":"300","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_009"} |
| Regulatory source | reproductive toxicity | 300 | mg/kg bw | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=300; DOSE=5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokinetics Absorption, distribution, metabolism and excretion have been investigated in the female Wistar Kyoto rat, a strain with a low acetylator phenotype. After oral administration, 14C-1- Hydroxyethyl-4,5-Diamino; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokinetics Absorption, distribution, metabolism and excretion have been investigated in the female Wistar Kyoto rat, a strain with a low acetylator phenotype. After oral administration, 14C-1- Hydroxyethyl-4,5-Diamino","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_011"} |
| Regulatory source | reproductive toxicity | 900 | mg/kg bw | - | - | prenatal | reproductive toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=900; DOSE=At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.; EFFECT=se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","duration":"prenatal","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"900","page":18,"route":"","species":"","study_id":"sccp_o_064_noael_002"} |
| Regulatory source | reproductive toxicity | 900 | mg/kg bw | rat | - | prenatal | reproductive toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=900; DOSE=At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.; EFFECT=se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclu; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 24 3","dose":"At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls.","duration":"prenatal","effect":"se groups. This sign is considered related to the colour of the test item. At necropsy, a decrease in testes weight and increase in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclu","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"900","page":23,"route":"","species":"rat","study_id":"sccs_o_079_noael_002"} |
| Regulatory source | reproductive toxicity | 900 | mg/kg bw/day | rat | - | prenatal | reproductive toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=900; DOSE=rease in spleen weight, were noted in high dose F0 animals when compared to controls.; EFFECT=rease in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 3; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"155601-30-2","citation":"Ref.: 24 3","dose":"rease in spleen weight, were noted in high dose F0 animals when compared to controls.","duration":"prenatal","effect":"rease in spleen weight, were noted in high dose F0 animals when compared to controls. No treatment related changes were seen at the macroscopic and histopathologic examinations. Conclusion No adverse effects were observed on gonadal function, mating, fertility, implantation, prenatal development and postnatal development of the offspring. The highest tested dose of 900 mg/kg bw was the foetal NOAEL. Due to the decrease of testes weight and an increase in spleen weight in the high dose group (900 mg/kg bw/day) the NOAEL for parental males and females is 300 mg/kg bw/ day. Ref.: 24 3.3.8.2. Teratogenicity Taken from SCCP/0990/06 Guideline: OECD 414 (1983) Species/strain: Rat, Sprague-Dawley, Crl: CD (SD) BR strain Group size: 24 females per dose Test substance: DA 010894 Batch: GST 6-26089 Purity: 99.2% (HPLC, 254 nm) Dose levels: 100, 300, 1000 mg/kg bw/day Exposure period: Days 6 to 17 of pregnancy, inclusive GLP: In compliance Three groups of 24 pregnant female rats each were dosed daily intragastrically at levels of 100, 3","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"900","page":23,"route":"","species":"rat","study_id":"sccs_o_079_noael_003"} |
| Regulatory source | reproductive toxicity | 1000 | mg/kg bw/day | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccp_o_064; REPORT_TITLE=Opinion on 1-HYDROXYETHYL-4,5-DIAMINO PYRAZOLE SULFATE COLIPA N° A154; OPINION_NUMBER=SCCP/0990/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 June 2006; VALUE_TEXT=1000; DOSE=General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=ity of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact allergen in a Magnusson and Kligman test. In a Buehler test, the substance showed no sensitising potential when applied epicutaneou; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"ity of 1-Hydroxyethyl-4,5-diamino pyrazole sulphate in test solutions and in marketed products is not reported. General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a 13-week study, the NOAEL was set at 250 mg/kg bw/day. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg/bw day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. Irritation / sensitisation This test substance is irritant to rabbit skin under the conditions of the experiment. A 5% of the test substance is irritant to rabbit eyes. The undiluted test compound may cause serious damage to eyes. The test compound was found an extremely potent contact allergen in a Magnusson and Kligman test. In a Buehler test, the substance showed no sensitising potential when applied epicutaneou","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulphate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":23,"route":"oral","species":"rat","study_id":"sccp_o_064_noael_008"} |
| Regulatory source | reproductive toxicity | 1000 | mg/kg bw/day | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccs_o_079; REPORT_TITLE=OPINION ON 1-Hydroxyethyl-4,5-diamino pyrazole sulfate COLIPA n° A154; OPINION_NUMBER=SCCS/1449/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=1000; DOSE=The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.; EFFECT=ncentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokinetics Absorption, distribution, metabolism and excretion have been investigated in the female Wistar Kyoto rat, a strain with a low; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"155601-30-2","citation":"","dose":"The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw.","duration":"13-week","effect":"ncentration of 3%, after mixing with peroxide. The stability of 1-Hydroxyethyl-4,5- diamino pyrazole sulphate in solutions used for oral toxicity testing is not reported General toxicity The acute oral LD50 in rats was greater than 2000 mg/kg bw. In rats, the 4 h LC50 value of an aerosol of the test substance was larger than 5.24 g/m³ for both sexes. In a reproductive toxicity study, the NOAEL for parental males and females is 300 mg/kg bw/ day. The foetal toxicity was 900 mg/kg bw. In a teratogenicity study, the NOAEL for maternal toxicity was 1000 mg/kg bw/day. 300 mg/kg bw was found as the NOAEL for foetotoxicity. In a 13-week study using daily intragastric dosing of the test animals at the highest tested dose of 800 mg/kg bw, marginal changes in some blood biochemical, haematological and spleen weight were observed. Based on these effects, the NOAEL in this study was 250 mg/kg bw/day. Toxicokinetics Absorption, distribution, metabolism and excretion have been investigated in the female Wistar Kyoto rat, a strain with a low","endpoint":"reproductive toxicity","ingredient":"1-Hydroxyethyl-4,5-diamino pyrazole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":27,"route":"oral","species":"rat","study_id":"sccs_o_079_noael_010"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 04N8KX12N6 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C5H10N4O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"04N8KX12N6"} |
| openFDA substances | FDA UNII substance identifier | 04N8KX12N6 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C5H10N4O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"04N8KX12N6"} |
| openFDA substances | FDA UNII substance identifier | 04N8KX12N6 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C5H10N4O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"04N8KX12N6"} |
| openFDA substances | FDA UNII substance identifier | 04N8KX12N6 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C5H10N4O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"04N8KX12N6"} |