NOAEL Studies
Preservative
Methylisothiazolinone NOAEL Studies
INCI: METHYLISOTHIAZOLINONE
CAS: 2682-20-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =0.34 | mg/m3 | rat | inhalation | - | inhalation toxicity | {"citation":"14; 2; 400","dose":"Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight.","effect":"as paints, cleaners, and plastics. In April 2020, the US Environmental Protection Agency (EPA) released a draft risk assessment for MCI/MI.14 Included were data and analyses of residential and occupational handler risks to inhalation of spray products containing Methylisothiazolinone and Methylisothiazolinone-preserved paints. Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight. The human equivalent concentrations for MCI/MI, derived from a no-observed-adverse-effect-concentration (NOAEC) of 0.34 mg/m3 (inhalation) in rats, are calculated to be 0.11 and 0.038 mg/m3, based upon an 8-hour and 24-hour time weighted average exposure period, respectively. The inhalation margins of exposure (MOEs) for residential Methylisothiazolinone aerosol and vapor exposures range from 1.0 to 14000, and the inhalation MOEs for occupational Methylisothiazolinone aerosol and vapor exposures range from 0.5 to 5800. Toxico- logical concern was noted when these values were less than the level of concern (LOC) of 10. Scenarios for...","page":3,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_001"} |
| CIR_vision_codex | NOAEL | =28.6 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"28; 6","dose":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups.","effect":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups. These observations were considered incidental as the high-dose group and high-dose recovery group were comparable to the control groups. While pathological and histopathological changes were observed, the study summary did not detail the differences between the control and dose groups. The no-observed- adverse-effect level (NOAEL) was 28.6 mg/kg bw/d in males","page":4,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_002"} |
| CIR_vision_codex | NOAEL | =220 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"71; 2; 97","dose":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality.","effect":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality. No further details were provided. Subchronic Toxicity Studies Oral. No toxic effects were observed when 97.5% Methylisothia- zolinone was administered to rats in drinking water for 13 weeks at concentrations of 0, 75, 250, or 1000 ppm.3 Dogs that were fed diets prepared with 51.4% Methylisothiazolinone for 3 months had an NOAEL of 1500 ppm. In a subchronic study, rats fed the metabolites NMMA and malonic acid (MA), up to 220 and 44 ppm in the diet, respectively, for 3 months showed no effects in body weight, food consumption, hematology, clinical chemis- try, urinalysis, ophthalmology, or gross pathologic changes. Bea- gle dogs that received up to 500 ppm NMMA and 100 ppm MA in their diets for 3 months had no systemic toxicity. In a 90-day oral toxicity study performed in accordance with OECD TG 408, groups of 10 male and 10 female Wistar rats received 0, 7.52, 15.05, or 30.09 mg/kg bw Me...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_003"} |
| CIR_vision_codex | NOAEL | =30.09 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"citation":"30; 09; 13","dose":"The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity.","effect":"ty, number, and morphology (results reported in the section below). Terminal studies included mea- suring organ weight and relative organ weight, and performing gross pathological and histopathological assessments. No treatment-related mortalities, clinical signs of toxicity, ophthal- mological changes, or changes in feed consumption were observed. There were no significant treatment-related changes in hematological values or clinical chemistry. No significant adverse effects were reported in terminal studies. The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity. Inhalation. While there are no published inhalation data on Methylisothiazolinone, a 13-week repeated-dose inhalation study on MCI/MI was performed in accordance with OECD TG 413.15 Groups of 16 Crl: CD(SD)BR rats per sex were exposed to 14% MCI/MI (11% MCI/3% MI). The rats were exposed whole body for 6 h/d, 5 d/wk, at aerosol Table 2. Acute Toxicity of Methylisothiazolinone. Concentration Dose Species/Strain Method Results Reference Dermal 49.0%; no veh...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_004"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"t necropsy had red areas in the glandular portion of the stomach and lungs. No treatment-related effects were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied i...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_005"} |
| CIR_vision_codex | NOAEL | =30 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"s were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied in Wistar rats in accordance with OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_006"} |
| CIR_vision_codex | NOAEL | =33.4 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"414; 5; 25","dose":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation.","effect":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay tha...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_007"} |
| CIR_vision_codex | NOAEL | =49.8 | mg/kg bw/d | - | oral | - | developmental toxicity | {"citation":"6; 15; 49","dose":"Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg.","effect":"water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay that studied Methylisothiazolinone at 97.5% ai (0.0785-5000 mg/mL) found significant increases in cells...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_008"} |
| CIR_vision_codex | NOAEL | =0.34 | mg/m3 | rat | inhalation | - | inhalation toxicity | {"citation":"14; 2; 400","dose":"Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight.","effect":"as paints, cleaners, and plastics. In April 2020, the US Environmental Protection Agency (EPA) released a draft risk assessment for MCI/MI.14 Included were data and analyses of residential and occupational handler risks to inhalation of spray products containing Methylisothiazolinone and Methylisothiazolinone-preserved paints. Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight. The human equivalent concentrations for MCI/MI, derived from a no-observed-adverse-effect-concentration (NOAEC) of 0.34 mg/m3 (inhalation) in rats, are calculated to be 0.11 and 0.038 mg/m3, based upon an 8-hour and 24-hour time weighted average exposure period, respectively. The inhalation margins of exposure (MOEs) for residential Methylisothiazolinone aerosol and vapor exposures range from 1.0 to 14000, and the inhalation MOEs for occupational Methylisothiazolinone aerosol and vapor exposures range from 0.5 to 5800. Toxico- logical concern was noted when these values were less than the level of concern (LOC) of 10. Scenarios for...","page":3,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_001"} |
| CIR_vision_codex | NOAEL | =28.6 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"28; 6","dose":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups.","effect":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups. These observations were considered incidental as the high-dose group and high-dose recovery group were comparable to the control groups. While pathological and histopathological changes were observed, the study summary did not detail the differences between the control and dose groups. The no-observed- adverse-effect level (NOAEL) was 28.6 mg/kg bw/d in males","page":4,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_002"} |
| CIR_vision_codex | NOAEL | =220 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"71; 2; 97","dose":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality.","effect":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality. No further details were provided. Subchronic Toxicity Studies Oral. No toxic effects were observed when 97.5% Methylisothia- zolinone was administered to rats in drinking water for 13 weeks at concentrations of 0, 75, 250, or 1000 ppm.3 Dogs that were fed diets prepared with 51.4% Methylisothiazolinone for 3 months had an NOAEL of 1500 ppm. In a subchronic study, rats fed the metabolites NMMA and malonic acid (MA), up to 220 and 44 ppm in the diet, respectively, for 3 months showed no effects in body weight, food consumption, hematology, clinical chemis- try, urinalysis, ophthalmology, or gross pathologic changes. Bea- gle dogs that received up to 500 ppm NMMA and 100 ppm MA in their diets for 3 months had no systemic toxicity. In a 90-day oral toxicity study performed in accordance with OECD TG 408, groups of 10 male and 10 female Wistar rats received 0, 7.52, 15.05, or 30.09 mg/kg bw Me...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_003"} |
| CIR_vision_codex | NOAEL | =30.09 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"citation":"30; 09; 13","dose":"The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity.","effect":"ty, number, and morphology (results reported in the section below). Terminal studies included mea- suring organ weight and relative organ weight, and performing gross pathological and histopathological assessments. No treatment-related mortalities, clinical signs of toxicity, ophthal- mological changes, or changes in feed consumption were observed. There were no significant treatment-related changes in hematological values or clinical chemistry. No significant adverse effects were reported in terminal studies. The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity. Inhalation. While there are no published inhalation data on Methylisothiazolinone, a 13-week repeated-dose inhalation study on MCI/MI was performed in accordance with OECD TG 413.15 Groups of 16 Crl: CD(SD)BR rats per sex were exposed to 14% MCI/MI (11% MCI/3% MI). The rats were exposed whole body for 6 h/d, 5 d/wk, at aerosol Table 2. Acute Toxicity of Methylisothiazolinone. Concentration Dose Species/Strain Method Results Reference Dermal 49.0%; no veh...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_004"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"t necropsy had red areas in the glandular portion of the stomach and lungs. No treatment-related effects were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied i...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_005"} |
| CIR_vision_codex | NOAEL | =30 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"s were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied in Wistar rats in accordance with OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_006"} |
| CIR_vision_codex | NOAEL | =33.4 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"414; 5; 25","dose":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation.","effect":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay tha...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_007"} |
| CIR_vision_codex | NOAEL | =49.8 | mg/kg bw/d | - | oral | - | developmental toxicity | {"citation":"6; 15; 49","dose":"Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg.","effect":"water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay that studied Methylisothiazolinone at 97.5% ai (0.0785-5000 mg/mL) found significant increases in cells...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_008"} |
| CIR_vision_codex | NOAEL | =0.34 | mg/m3 | rat | inhalation | - | inhalation toxicity | {"citation":"14; 2; 400","dose":"Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight.","effect":"as paints, cleaners, and plastics. In April 2020, the US Environmental Protection Agency (EPA) released a draft risk assessment for MCI/MI.14 Included were data and analyses of residential and occupational handler risks to inhalation of spray products containing Methylisothiazolinone and Methylisothiazolinone-preserved paints. Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight. The human equivalent concentrations for MCI/MI, derived from a no-observed-adverse-effect-concentration (NOAEC) of 0.34 mg/m3 (inhalation) in rats, are calculated to be 0.11 and 0.038 mg/m3, based upon an 8-hour and 24-hour time weighted average exposure period, respectively. The inhalation margins of exposure (MOEs) for residential Methylisothiazolinone aerosol and vapor exposures range from 1.0 to 14000, and the inhalation MOEs for occupational Methylisothiazolinone aerosol and vapor exposures range from 0.5 to 5800. Toxico- logical concern was noted when these values were less than the level of concern (LOC) of 10. Scenarios for...","page":3,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_001"} |
| CIR_vision_codex | NOAEL | =28.6 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"28; 6","dose":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups.","effect":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups. These observations were considered incidental as the high-dose group and high-dose recovery group were comparable to the control groups. While pathological and histopathological changes were observed, the study summary did not detail the differences between the control and dose groups. The no-observed- adverse-effect level (NOAEL) was 28.6 mg/kg bw/d in males","page":4,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_002"} |
| CIR_vision_codex | NOAEL | =220 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"71; 2; 97","dose":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality.","effect":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality. No further details were provided. Subchronic Toxicity Studies Oral. No toxic effects were observed when 97.5% Methylisothia- zolinone was administered to rats in drinking water for 13 weeks at concentrations of 0, 75, 250, or 1000 ppm.3 Dogs that were fed diets prepared with 51.4% Methylisothiazolinone for 3 months had an NOAEL of 1500 ppm. In a subchronic study, rats fed the metabolites NMMA and malonic acid (MA), up to 220 and 44 ppm in the diet, respectively, for 3 months showed no effects in body weight, food consumption, hematology, clinical chemis- try, urinalysis, ophthalmology, or gross pathologic changes. Bea- gle dogs that received up to 500 ppm NMMA and 100 ppm MA in their diets for 3 months had no systemic toxicity. In a 90-day oral toxicity study performed in accordance with OECD TG 408, groups of 10 male and 10 female Wistar rats received 0, 7.52, 15.05, or 30.09 mg/kg bw Me...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_003"} |
| CIR_vision_codex | NOAEL | =30.09 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"citation":"30; 09; 13","dose":"The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity.","effect":"ty, number, and morphology (results reported in the section below). Terminal studies included mea- suring organ weight and relative organ weight, and performing gross pathological and histopathological assessments. No treatment-related mortalities, clinical signs of toxicity, ophthal- mological changes, or changes in feed consumption were observed. There were no significant treatment-related changes in hematological values or clinical chemistry. No significant adverse effects were reported in terminal studies. The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity. Inhalation. While there are no published inhalation data on Methylisothiazolinone, a 13-week repeated-dose inhalation study on MCI/MI was performed in accordance with OECD TG 413.15 Groups of 16 Crl: CD(SD)BR rats per sex were exposed to 14% MCI/MI (11% MCI/3% MI). The rats were exposed whole body for 6 h/d, 5 d/wk, at aerosol Table 2. Acute Toxicity of Methylisothiazolinone. Concentration Dose Species/Strain Method Results Reference Dermal 49.0%; no veh...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_004"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"t necropsy had red areas in the glandular portion of the stomach and lungs. No treatment-related effects were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied i...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_005"} |
| CIR_vision_codex | NOAEL | =30 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"s were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied in Wistar rats in accordance with OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_006"} |
| CIR_vision_codex | NOAEL | =33.4 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"414; 5; 25","dose":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation.","effect":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay tha...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_007"} |
| CIR_vision_codex | NOAEL | =49.8 | mg/kg bw/d | - | oral | - | developmental toxicity | {"citation":"6; 15; 49","dose":"Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg.","effect":"water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay that studied Methylisothiazolinone at 97.5% ai (0.0785-5000 mg/mL) found significant increases in cells...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_008"} |
| CIR_vision_codex | NOAEL | =0.34 | mg/m3 | rat | inhalation | - | inhalation toxicity | {"citation":"14; 2; 400","dose":"Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight.","effect":"as paints, cleaners, and plastics. In April 2020, the US Environmental Protection Agency (EPA) released a draft risk assessment for MCI/MI.14 Included were data and analyses of residential and occupational handler risks to inhalation of spray products containing Methylisothiazolinone and Methylisothiazolinone-preserved paints. Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight. The human equivalent concentrations for MCI/MI, derived from a no-observed-adverse-effect-concentration (NOAEC) of 0.34 mg/m3 (inhalation) in rats, are calculated to be 0.11 and 0.038 mg/m3, based upon an 8-hour and 24-hour time weighted average exposure period, respectively. The inhalation margins of exposure (MOEs) for residential Methylisothiazolinone aerosol and vapor exposures range from 1.0 to 14000, and the inhalation MOEs for occupational Methylisothiazolinone aerosol and vapor exposures range from 0.5 to 5800. Toxico- logical concern was noted when these values were less than the level of concern (LOC) of 10. Scenarios for...","page":3,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_001"} |
| CIR_vision_codex | NOAEL | =28.6 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"28; 6","dose":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups.","effect":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups. These observations were considered incidental as the high-dose group and high-dose recovery group were comparable to the control groups. While pathological and histopathological changes were observed, the study summary did not detail the differences between the control and dose groups. The no-observed- adverse-effect level (NOAEL) was 28.6 mg/kg bw/d in males","page":4,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_002"} |
| CIR_vision_codex | NOAEL | =220 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"71; 2; 97","dose":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality.","effect":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality. No further details were provided. Subchronic Toxicity Studies Oral. No toxic effects were observed when 97.5% Methylisothia- zolinone was administered to rats in drinking water for 13 weeks at concentrations of 0, 75, 250, or 1000 ppm.3 Dogs that were fed diets prepared with 51.4% Methylisothiazolinone for 3 months had an NOAEL of 1500 ppm. In a subchronic study, rats fed the metabolites NMMA and malonic acid (MA), up to 220 and 44 ppm in the diet, respectively, for 3 months showed no effects in body weight, food consumption, hematology, clinical chemis- try, urinalysis, ophthalmology, or gross pathologic changes. Bea- gle dogs that received up to 500 ppm NMMA and 100 ppm MA in their diets for 3 months had no systemic toxicity. In a 90-day oral toxicity study performed in accordance with OECD TG 408, groups of 10 male and 10 female Wistar rats received 0, 7.52, 15.05, or 30.09 mg/kg bw Me...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_003"} |
| CIR_vision_codex | NOAEL | =30.09 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"citation":"30; 09; 13","dose":"The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity.","effect":"ty, number, and morphology (results reported in the section below). Terminal studies included mea- suring organ weight and relative organ weight, and performing gross pathological and histopathological assessments. No treatment-related mortalities, clinical signs of toxicity, ophthal- mological changes, or changes in feed consumption were observed. There were no significant treatment-related changes in hematological values or clinical chemistry. No significant adverse effects were reported in terminal studies. The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity. Inhalation. While there are no published inhalation data on Methylisothiazolinone, a 13-week repeated-dose inhalation study on MCI/MI was performed in accordance with OECD TG 413.15 Groups of 16 Crl: CD(SD)BR rats per sex were exposed to 14% MCI/MI (11% MCI/3% MI). The rats were exposed whole body for 6 h/d, 5 d/wk, at aerosol Table 2. Acute Toxicity of Methylisothiazolinone. Concentration Dose Species/Strain Method Results Reference Dermal 49.0%; no veh...","page":5,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_004"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"t necropsy had red areas in the glandular portion of the stomach and lungs. No treatment-related effects were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied i...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_005"} |
| CIR_vision_codex | NOAEL | =30 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | {"citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","effect":"s were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied in Wistar rats in accordance with OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_006"} |
| CIR_vision_codex | NOAEL | =33.4 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"414; 5; 25","dose":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation.","effect":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay tha...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_007"} |
| CIR_vision_codex | NOAEL | =49.8 | mg/kg bw/d | - | oral | - | developmental toxicity | {"citation":"6; 15; 49","dose":"Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg.","effect":"water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay that studied Methylisothiazolinone at 97.5% ai (0.0785-5000 mg/mL) found significant increases in cells...","page":6,"pdf":"PRS821.pdf","row_type":"noael_study","study_id":"PRS821_noael_008"} |
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 75 | ppm | rat | oral | 90 day | Subchronic | FCN; Three-Month Drinking Water Toxicity Study in Rats |
NTP_ICE_acute_dermal 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_dermal | EPA classification | 4 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=750; Record_ID=acute_dermal_368; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.3; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=4.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_dermal | EPA classification | 2 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=755; Record_ID=acute_dermal_285; Data_Type=In Vivo; Formulation_ID=MIX278; Formulation_Name=Kathon CF 400; Percent_Active_Ingredient=1.05; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=2.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_dermal | EPA classification | 3 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=759; Record_ID=acute_dermal_11; Data_Type=In Vivo; Formulation_ID=MIX11; Formulation_Name=Acticide SR 8213 C; Percent_Active_Ingredient=10.0; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=3.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_dermal | GHS classification | 5 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=753; Record_ID=acute_dermal_8; Data_Type=In Vivo; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=0.65; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Dermal Toxicity; Endpoint=GHS classification; Response=5.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_dermal | LD50 | >5000 | mg/kg | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=748; Record_ID=acute_dermal_368; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.3; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=5000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_dermal | LD50 | >2000 | mg/kg | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=751; Record_ID=acute_dermal_11; Data_Type=In Vivo; Formulation_ID=MIX11; Formulation_Name=Acticide SR 8213 C; Percent_Active_Ingredient=10.0; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=2000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
NTP_ICE_acute_inhalation 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | EPA Classification | 2 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1623; Record_ID=acute_inhalation_466; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX60; Formulation_Name=Bioban 425 Antimicrobial; Percent_Active_Ingredient=15.0; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=EPA Classification; Response=2; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | EPA Classification | 3 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1624; Record_ID=acute_inhalation_293; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.3; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | GHS Classification | 4 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1631; Record_ID=acute_inhalation_329; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX400; Formulation_Name=Rocima 586; Percent_Active_Ingredient=0.28; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=GHS Classification; Response=4; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.21 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1620; Record_ID=acute_inhalation_29; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=0.65; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.21; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | range0.52 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1621; Record_ID=acute_inhalation_293; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.3; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=range; Response=>0.52 and <2.05; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 1.69 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1622; Record_ID=acute_inhalation_329; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX400; Formulation_Name=Rocima 586; Percent_Active_Ingredient=0.28; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=1.69; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.11 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1632; Record_ID=acute_inhalation_1047; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.11; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/3/3/?documentUUID=689d5e1b-a6e1-4771-a5f1-087cf7146040; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.13 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1633; Record_ID=acute_inhalation_1051; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.13; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/3/3/?documentUUID=689d5e1b-a6e1-4771-a5f1-087cf7146040; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.1 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1634; Record_ID=acute_inhalation_1055; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.1; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/3/3/?documentUUID=689d5e1b-a6e1-4771-a5f1-087cf7146040; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.35 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1635; Record_ID=acute_inhalation_1078; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.35; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/3/3/?documentUUID=3ccf380c-35c9-4ecd-87e3-f25bc496d064; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.38 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1636; Record_ID=acute_inhalation_466; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX60; Formulation_Name=Bioban 425 Antimicrobial; Percent_Active_Ingredient=15; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.38; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_acute_inhalation | LC50 | 0.73 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1638; Record_ID=acute_inhalation_26; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=3.903; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.73; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
NTP_ICE_acute_oral 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13156; row=4470; data_type=In Vivo; mixture=Mixture; formulation_id=MIX663; formulation_name=Acticide CBM 2; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=5.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12197; row=4471; data_type=In Vivo; mixture=Mixture; formulation_id=MIX11; formulation_name=Acticide SR 8213 C; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=10.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =2 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12286; row=4472; data_type=In Vivo; mixture=Mixture; formulation_id=MIX60; formulation_name=Bioban 425 Antimicrobial; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=15.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13224; row=4473; data_type=In Vivo; mixture=Mixture; formulation_id=MIX278; formulation_name=Kathon CF 400; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=1.05; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12860; row=4474; data_type=In Vivo; mixture=Mixture; formulation_id=MIX361; formulation_name=Preventol P 91; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.3; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12959; row=4477; data_type=In Vivo; mixture=Mixture; formulation_id=MIX400; formulation_name=Rocima 586; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.28; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12185; row=4491; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=3.903; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =2 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12189; row=4493; data_type=In Vivo; mixture=Mixture; formulation_id=MIX8; formulation_name=Acticide LA 2605-F; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.65; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12860; row=4475; data_type=In Vivo; mixture=Mixture; formulation_id=MIX361; formulation_name=Preventol P 91; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.3; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12959; row=4476; data_type=In Vivo; mixture=Mixture; formulation_id=MIX400; formulation_name=Rocima 586; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.28; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =5 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12185; row=4478; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=3.903; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13156; row=4479; data_type=In Vivo; mixture=Mixture; formulation_id=MIX663; formulation_name=Acticide CBM 2; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=5.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12189; row=4480; data_type=In Vivo; mixture=Mixture; formulation_id=MIX8; formulation_name=Acticide LA 2605-F; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.65; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12197; row=4488; data_type=In Vivo; mixture=Mixture; formulation_id=MIX11; formulation_name=Acticide SR 8213 C; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=10.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12286; row=4490; data_type=In Vivo; mixture=Mixture; formulation_id=MIX60; formulation_name=Bioban 425 Antimicrobial; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=15.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13224; row=4492; data_type=In Vivo; mixture=Mixture; formulation_id=MIX278; formulation_name=Kathon CF 400; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=1.05; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | >2000 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12185; row=4481; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=3.903; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =97 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12286; row=4482; data_type=In Vivo; mixture=Mixture; formulation_id=MIX60; formulation_name=Bioban 425 Antimicrobial; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=15.0; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1030 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12860; row=4483; data_type=In Vivo; mixture=Mixture; formulation_id=MIX361; formulation_name=Preventol P 91; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.3; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =105 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_4872; row=4484; data_type=In Vivo; mixture=Chemical; chemical_name=2-Methyl-3(2H)-isothiazolone; preferred_name=2-Methyl-3(2H)-isothiazolone; dtxsid=DTXSID2034259; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =183 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_4874; row=4485; data_type=In Vivo; mixture=Chemical; chemical_name=2-Methyl-3(2H)-isothiazolone; preferred_name=2-Methyl-3(2H)-isothiazolone; dtxsid=DTXSID2034259; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1091 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_4876; row=4486; data_type=In Vivo; mixture=Chemical; chemical_name=2-Methyl-3(2H)-isothiazolone; preferred_name=2-Methyl-3(2H)-isothiazolone; dtxsid=DTXSID2034259; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2834 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_4878; row=4487; data_type=In Vivo; mixture=Chemical; chemical_name=2-Methyl-3(2H)-isothiazolone; preferred_name=2-Methyl-3(2H)-isothiazolone; dtxsid=DTXSID2034259; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2000 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12959; row=4489; data_type=In Vivo; mixture=Mixture; formulation_id=MIX400; formulation_name=Rocima 586; chemical_name=Methylisothiazolinone; preferred_name=2-Methyl-3(2H)-isothiazolone; percent_active_ingredient=0.28; dtxsid=DTXSID2034259; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259; source_file=acute_oral.xlsx |
NTP_ICE_eye_irritation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | EPA Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=863; Record_ID=eye_irritation_391; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID47; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=3.903; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
NTP_ICE_skin_irritation 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_irritation | EPA classification | 1 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=605; Record_ID=skin_irritation_invivo_516; Data_Type=In Vivo; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=0.65; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_irritation | EPA classification | 1 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=606; Record_ID=skin_irritation_invivo_849; Data_Type=In Vivo; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=0.65; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reported_Strain=New Zealand White; Strain=New Zealand White; Sex=Male; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_irritation | EPA classification | 2 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=607; Record_ID=skin_irritation_invivo_751; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.3; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=2; Response_Unit=Unitless; Species=Rabbit; Reported_Strain=New Zealand White; Strain=New Zealand White; Sex=Female; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_irritation | EPA classification | 3 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=610; Record_ID=skin_irritation_invivo_523; Data_Type=In Vivo; Formulation_ID=MIX11; Formulation_Name=Acticide SR 8213 C; Percent_Active_Ingredient=10; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_irritation | EPA classification | 2 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=612; Record_ID=skin_irritation_invivo_378; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.3; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=2; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_irritation | EPA classification | 3 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=615; Record_ID=skin_irritation_invivo_857; Data_Type=In Vivo; Formulation_ID=MIX11; Formulation_Name=Acticide SR 8213 C; Percent_Active_Ingredient=10; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reported_Strain=New Zealand White; Strain=New Zealand White; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
NTP_ICE_skin_sensitization 42 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD54, EC200 | 7.89 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2043; Record_ID=skin_sensitization_invitro_511; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=7.89; Reported_Response_Unit=ug/mL; Response=7.89; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 9.23 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2044; Record_ID=skin_sensitization_invitro_511; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=h-CLAT; Endpoint=CD86, EC150; Reported_Response=9.23; Reported_Response_Unit=ug/mL; Response=9.23; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 4.594 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8312; Record_ID=skin_sensitization_invitro_2304; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=39.9; Reported_Response_Unit=uM; Conversion_Factor_Value=115.15; Conversion_Factor_Source=EPA Dashboard; Converted_Response=4.594; Converted_Response_Unit=ug/mL; Response=4.594; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 9 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8540; Record_ID=skin_sensitization_invitro_2355; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=9; Reported_Response_Unit=ug/mL; Response=9; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | CV70 | 44.3 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8538; Record_ID=skin_sensitization_invitro_2355; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=U-SENS; Endpoint=CV70; Reported_Response=44.3; Reported_Response_Unit=ug/mL; Response=44.3; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | CV75 | 24.7 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2045; Record_ID=skin_sensitization_invitro_511; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=h-CLAT; Endpoint=CV75; Reported_Response=24.7; Reported_Response_Unit=ug/mL; Response=24.7; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Concentration, 5% incidence of positive responses | 0.232 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6505; Record_ID=skin_sensitization_invivo_1487; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.04; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Concentration, 5% incidence of positive responses; Response=0.232; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Concentration, 5% incidence of positive responses | 0.525 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6521; Record_ID=skin_sensitization_invivo_1489; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Concentration, 5% incidence of positive responses; Response=0.525; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Concentration, one positive response | 0.04 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6501; Record_ID=skin_sensitization_invivo_1487; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.04; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Concentration, one positive response; Response=0.04; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Concentration, one positive response | 0.05 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6517; Record_ID=skin_sensitization_invivo_1489; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Concentration, one positive response; Response=0.05; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Depletion Cys | 97.9 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=870; Record_ID=skin_sensitization_invitro_241; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=97.9; Reported_Response_Unit=%; Response=97.9; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Depletion Cys | 100 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=874; Record_ID=skin_sensitization_invitro_242; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=100; Reported_Response_Unit=%; Response=100; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Depletion Lys | -5.6 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=869; Record_ID=skin_sensitization_invitro_241; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=-5.6; Reported_Response_Unit=%; Response=-5.6; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Depletion Lys | 1.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=873; Record_ID=skin_sensitization_invitro_242; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=1.1000000000000001; Reported_Response_Unit=%; Response=1.1; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 46.15 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=871; Record_ID=skin_sensitization_invitro_241; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=46.15; Reported_Response_Unit=%; Response=46.15; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 51 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=875; Record_ID=skin_sensitization_invitro_242; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=51; Reported_Response_Unit=%; Response=51; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC1.5 | 11.78 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8786; Record_ID=skin_sensitization_invitro_2434; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=11.78; Reported_Response_Unit=uM; Response=11.78; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Joint Research Centre of the European Union 2014|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 29.56 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8787; Record_ID=skin_sensitization_invitro_2434; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=KeratinoSens; Endpoint=EC3; Reported_Response=29.559000000000001; Reported_Response_Unit=uM; Response=29.56; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Joint Research Centre of the European Union 2014|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 1.9 | % | Mouse | Dermal | - | In Vivo; Urbisch_SkinSensitization2020; LLNA | sheet=Data_invivo; excel_row=12809; Record_ID=skin_sensitization_invivo_2810; Data_Type=In Vivo; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=1.9; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 0.37 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13439; Record_ID=skin_sensitization_invivo_3588; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=0.37; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 2.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13440; Record_ID=skin_sensitization_invivo_3589; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 0.37 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13439; Record_ID=skin_sensitization_invivo_3588; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=0.37; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 2.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13440; Record_ID=skin_sensitization_invivo_3589; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 0.37 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13439; Record_ID=skin_sensitization_invivo_3588; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=0.37; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 2.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13440; Record_ID=skin_sensitization_invivo_3589; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 0.37 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13439; Record_ID=skin_sensitization_invivo_3588; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=0.37; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | EC3 | 2.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13440; Record_ID=skin_sensitization_invivo_3589; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 2003; Not available; 10.1081/CUS-120026299; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | GHS Classification | 1 | unitless | Guinea pig | Dermal | - | In Vivo; SkinSensitization6pack; Guinea Pig Maximization/Buehler | sheet=Data_invivo; excel_row=732; Record_ID=skin_sensitization_invivo_28; Data_Type=In Vivo; Internal_Data_Source=SkinSensitization6pack; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=0.65; Mixture=Mixture; DTXSID=DTXSID2034259; Assay=Guinea Pig Maximization/Buehler; Endpoint=GHS Classification; Response=1; Response_Unit=Unitless; Species=Guinea pig; Route=Dermal; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | IC50 | 139 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8788; Record_ID=skin_sensitization_invitro_2434; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=138.97999999999999; Reported_Response_Unit=uM; Response=139; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Joint Research Centre of the European Union 2014|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Imax | 22.6 | ratio | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8789; Record_ID=skin_sensitization_invitro_2434; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=22.6; Reported_Response_Unit=Unitless; Response=22.6; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Joint Research Centre of the European Union 2014|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6475; Record_ID=skin_sensitization_invivo_1483; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.01; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0.8621 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6497; Record_ID=skin_sensitization_invivo_1487; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.04; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=0.8621; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0.4762 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6513; Record_ID=skin_sensitization_invivo_1489; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=0.4762; Response_Unit=%; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 10 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6481; Record_ID=skin_sensitization_invivo_1484; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.02; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=10; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 15 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6488; Record_ID=skin_sensitization_invivo_1485; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.03; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=15; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 20 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6495; Record_ID=skin_sensitization_invivo_1487; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.04; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=20; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 25 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6511; Record_ID=skin_sensitization_invivo_1489; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=25; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 30 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6528; Record_ID=skin_sensitization_invivo_1491; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.06; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=30; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area, 5% incidence of positive responses | 116 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6507; Record_ID=skin_sensitization_invivo_1487; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.04; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area, 5% incidence of positive responses; Response=116; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Induction dose per skin area, 5% incidence of positive responses | 262.5 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6523; Record_ID=skin_sensitization_invivo_1489; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area, 5% incidence of positive responses; Response=262.5; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Relative reliability score | 4 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6479; Record_ID=skin_sensitization_invivo_1483; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.01; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=4; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
| NTP_ICE_skin_sensitization | Relative reliability score | 3 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=6487; Record_ID=skin_sensitization_invivo_1484; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.02; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2034259; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Rohm and Haas 2000; Not available; Not available|SCCNFP 2003; https://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out_201.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2034259 |
SCCNFP_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =19 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | % | rat | oral | 90 day | dermal absorption | {"dose":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a prese","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =250 | ppm | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 4 2","dose":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing.","effect":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing. Haematology and clinical chemistry revealed no treatment-related changes in either sex at any dose level. There were no treatment-related gross or microscopic pathological findings at any dose level in either sex. Based on effects on body weight and feed consumption at 1000 ppm (65.7 and 93.5 mg a.i./kg bw/day in males and females respectively) the NOAEL in this study was 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg bw/day in males and females, respectively). Ref. : 4 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out_201.pdf","row_type":"noael_study","study_id":"out_201_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =19 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | % | rat | oral | 90 day | dermal absorption | {"dose":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a prese","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =250 | ppm | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 4 2","dose":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing.","effect":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing. Haematology and clinical chemistry revealed no treatment-related changes in either sex at any dose level. There were no treatment-related gross or microscopic pathological findings at any dose level in either sex. Based on effects on body weight and feed consumption at 1000 ppm (65.7 and 93.5 mg a.i./kg bw/day in males and females respectively) the NOAEL in this study was 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg bw/day in males and females, respectively). Ref. : 4 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out_201.pdf","row_type":"noael_study","study_id":"out_201_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =19 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | % | rat | oral | 90 day | dermal absorption | {"dose":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a prese","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =250 | ppm | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 4 2","dose":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing.","effect":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing. Haematology and clinical chemistry revealed no treatment-related changes in either sex at any dose level. There were no treatment-related gross or microscopic pathological findings at any dose level in either sex. Based on effects on body weight and feed consumption at 1000 ppm (65.7 and 93.5 mg a.i./kg bw/day in males and females respectively) the NOAEL in this study was 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg bw/day in males and females, respectively). Ref. : 4 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out_201.pdf","row_type":"noael_study","study_id":"out_201_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =19 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | % | rat | oral | 90 day | dermal absorption | {"dose":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","effect":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a prese","page":9,"pdf":"out270_en.pdf","row_type":"noael_study","study_id":"out270_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =250 | ppm | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 4 2","dose":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing.","effect":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing. Haematology and clinical chemistry revealed no treatment-related changes in either sex at any dose level. There were no treatment-related gross or microscopic pathological findings at any dose level in either sex. Based on effects on body weight and feed consumption at 1000 ppm (65.7 and 93.5 mg a.i./kg bw/day in males and females respectively) the NOAEL in this study was 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg bw/day in males and females, respectively). Ref. : 4 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out_201.pdf","row_type":"noael_study","study_id":"out_201_noael_001"} |
SCCS_vision_codex 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =15 | µg/cm2 | - | - | - | sensitisation | {"dose":"Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water;","effect":"SCCS/1557/15 Final Opinion on Methylisothiazolinone (MI) (P94), submission III, sensitisation only 13 Taking all of the data together, since the HRIPT threshold is the lowest no observed effect level (NOEL) available, it shall, according to the submission, take precedence in deriving the NESIL for use in the QRA. Therefore, the WoE NESIL for MI is 15µg/cm2. A summary of the considered HRIPT studies (26) conducted on MI is given in the submission as table 2 and reproduced below: Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water; 0.2ml, 4 cm2 200ppm (10 µg/cm2) 200ppm 0 / 100 Water; 0.2ml, 4 cm2 300ppm (15 µg/cm2) 300ppm 0 / 98 Water; 0.2ml, 4 cm2 400pp","page":13,"pdf":"sccs_o_178.pdf","row_type":"noael_study","study_id":"sccs_o_178_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | µg/cm2 | - | - | - | sensitisation | {"dose":"Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water;","effect":"SCCS/1557/15 Final Opinion on Methylisothiazolinone (MI) (P94), submission III, sensitisation only 13 Taking all of the data together, since the HRIPT threshold is the lowest no observed effect level (NOEL) available, it shall, according to the submission, take precedence in deriving the NESIL for use in the QRA. Therefore, the WoE NESIL for MI is 15µg/cm2. A summary of the considered HRIPT studies (26) conducted on MI is given in the submission as table 2 and reproduced below: Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water; 0.2ml, 4 cm2 200ppm (10 µg/cm2) 200ppm 0 / 100 Water; 0.2ml, 4 cm2 300ppm (15 µg/cm2) 300ppm 0 / 98 Water; 0.2ml, 4 cm2 400pp","page":13,"pdf":"sccs_o_178.pdf","row_type":"noael_study","study_id":"sccs_o_178_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | µg/cm2 | - | - | - | sensitisation | {"dose":"Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water;","effect":"SCCS/1557/15 Final Opinion on Methylisothiazolinone (MI) (P94), submission III, sensitisation only 13 Taking all of the data together, since the HRIPT threshold is the lowest no observed effect level (NOEL) available, it shall, according to the submission, take precedence in deriving the NESIL for use in the QRA. Therefore, the WoE NESIL for MI is 15µg/cm2. A summary of the considered HRIPT studies (26) conducted on MI is given in the submission as table 2 and reproduced below: Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water; 0.2ml, 4 cm2 200ppm (10 µg/cm2) 200ppm 0 / 100 Water; 0.2ml, 4 cm2 300ppm (15 µg/cm2) 300ppm 0 / 98 Water; 0.2ml, 4 cm2 400pp","page":13,"pdf":"sccs_o_178.pdf","row_type":"noael_study","study_id":"sccs_o_178_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | µg/cm2 | - | - | - | sensitisation | {"dose":"Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water;","effect":"SCCS/1557/15 Final Opinion on Methylisothiazolinone (MI) (P94), submission III, sensitisation only 13 Taking all of the data together, since the HRIPT threshold is the lowest no observed effect level (NOEL) available, it shall, according to the submission, take precedence in deriving the NESIL for use in the QRA. Therefore, the WoE NESIL for MI is 15µg/cm2. A summary of the considered HRIPT studies (26) conducted on MI is given in the submission as table 2 and reproduced below: Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water; 0.2ml, 4 cm2 200ppm (10 µg/cm2) 200ppm 0 / 100 Water; 0.2ml, 4 cm2 300ppm (15 µg/cm2) 300ppm 0 / 98 Water; 0.2ml, 4 cm2 400pp","page":13,"pdf":"sccs_o_178.pdf","row_type":"noael_study","study_id":"sccs_o_178_noael_001"} |
ToxValDB_ECHA_IUCLID 19 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | =71.2 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6dab; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15830454_15850925:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_611d136a8bd77a147a369a78197c25de |
| ToxValDB_ECHA_IUCLID | NOAEC | =200 | mg/L | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15856921:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d37f5069be279439cd09f8e57a1788a3 |
| ToxValDB_ECHA_IUCLID | NOAEL | =30 | mg/kg bw/day | Rabbit | oral | - | developmental | GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd287; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/3?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15823528:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7f1a5e80a41e516901dbcbc1153fb274 |
| ToxValDB_ECHA_IUCLID | NOAEL | =40 | mg/kg bw/day | Rat | oral | - | developmental | GUIDELINE=EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd28b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/3?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15825457:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_fea294161846afca8e6962a68cfddefa |
| ToxValDB_ECHA_IUCLID | NOAEL | >=40.6 | mg/kg bw/day | Dog | oral | acute; 2 hours | acute | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb01e4b0a7c65d2245f7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847078_15847079:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5bd02ec2c7083c968143e97305a26e59 |
| ToxValDB_ECHA_IUCLID | NOAEL | <=40.9 | mg/kg bw/day | Dog | oral | acute; 2 hours | acute | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb01e4b0a7c65d2245f7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847078_15847079:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_11c6684c4c883756df5d0b7c2f50edce |
| ToxValDB_ECHA_IUCLID | NOAEL | =24.6 | mg/kg bw/day | Rat | oral | subchronic; 3 months | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6daf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15850924:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_619f097c93721659cbc9263565b4dfc5 |
| ToxValDB_ECHA_IUCLID | NOAEL | =28.6 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6dab; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15830454_15850925:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_61bbfe020730c1919aa15671bbe1e797 |
| ToxValDB_ECHA_IUCLID | NOAEL | =19 | mg/kg bw/day | Rat | oral | subchronic; 3 months | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6daf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15850948:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7e9d5aaae2afdab682a4ee4f25902b5b |
| ToxValDB_ECHA_IUCLID | NOAEL | =30.09 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6db9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15851018:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_e2c17389e47df043360d632659eff11f |
| ToxValDB_ECHA_IUCLID | NOAEL | >=15 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ba9e0eb97ed52d1a5c05df192c550aa8 |
| ToxValDB_ECHA_IUCLID | NOAEL | <=22 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3bd8999adad0d017cd6e9ad9446932de |
| ToxValDB_ECHA_IUCLID | NOAEL | <=26 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_edfbf78ca90c1fb691b71ef7f2a953d7 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=69 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4164247d6ef3c8e9d4e7532dd6296c70 |
| ToxValDB_ECHA_IUCLID | NOAEL | <=93 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_faf83717efa0605bbd08321e9c70bb61 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=86 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ce680ef658a92044a8b11c25e4a07b3e |
| ToxValDB_ECHA_IUCLID | NOAEL | <=115 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaae0e4b0a7c65d1b7d4c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/9/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860304_15860305_15860319_15860320_15860331_15860332_15860342_15863190:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c2f69c616c1d94a33746e63f8a7a2e87 |
| ToxValDB_ECHA_IUCLID | NOEL | =9.9 | mg/kg bw/day | Dog | oral | acute; 2 hours | acute | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb01e4b0a7c65d2245f7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15842488:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d43f03cc49596d8abd1fa9ec16cc287b |
| ToxValDB_ECHA_IUCLID | NOEL | =11.1 | mg/kg bw/day | Dog | oral | acute; 2 hours | acute | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb01e4b0a7c65d2245f7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23868/7/6/2?documentUUID=f1730ae9-9cc5-4620-bad1-8d8cc7b1b558; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=ECHA IUCLID:15842489:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e951c0f2b32ba9be4b733a3d291dae59 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL local | =0.021 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15633422:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4218f5894f554c91aa226ff015d58352 |
UnifiedCodex:CIR:beta.noael_studies 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | - | 28.6 | mg/kg bw/d | - | - | - | - | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=28.6; DOSE=hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups.; EFFECT=hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups. These observations were considered incidental as the high-dose group and high-dose recovery group were comparable to the control groups. While pathological and histopathological changes were observed, the study summary did not detail the differences between the control and dose groups. The no-observed- adverse-effect level (NOAEL) was 28.6 mg/kg bw/d in males; CITATION=28; 6; CITATION_NUMBERS=[28,6]; REFERENCE=28; 6; DETAILS_JSON={"cas_number":"2682-20-4","citation":"28; 6","dose":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups.","duration":"","effect":"hts of the organs in the treated animals were comparable to the con- trols, but there were statistically significant increases in relative weight of the kidneys in the low- and mid-dose groups. These observations were considered incidental as the high-dose group and high-dose recovery group were comparable to the control groups. While pathological and histopathological changes were observed, the study summary did not detail the differences between the control and dose groups. The no-observed- adverse-effect level (NOAEL) was 28.6 mg/kg bw/d in males","endpoint":"","ingredient":"Methylisothiazolinone","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"28.6","page":4,"route":"","species":"","study_id":"PRS821_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 33.4 | mg/kg bw/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=33.4; DOSE=OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation.; LOAEL_VALUE=33.4 mg/kg bw/d; EFFECT=OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay tha...; CITATION=414; 5; 25; CITATION_NUMBERS=[414,5,25]; REFERENCE=414; 5; 25; DETAILS_JSON={"cas_number":"2682-20-4","citation":"414; 5; 25","dose":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation.","duration":"","effect":"OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7 mg/kg of the test material in water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay tha...","endpoint":"developmental toxicity","ingredient":"Methylisothiazolinone","loael_value":"33.4 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"33.4","page":6,"route":"oral","species":"rat","study_id":"PRS821_noael_007"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 49.8 | mg/kg bw/d | - | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=49.8; DOSE=Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg.; LOAEL_VALUE=33.4 mg/kg bw/d; EFFECT=water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay that studied Methylisothiazolinone at 97.5% ai (0.0785-5000 mg/mL) found significant increases in cells...; CITATION=6; 15; 49; CITATION_NUMBERS=[6,15,49]; REFERENCE=6; 15; 49; DETAILS_JSON={"cas_number":"2682-20-4","citation":"6; 15; 49","dose":"Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg.","duration":"","effect":"water via gavage once daily on days 6 through 15 of gestation. Slight maternal toxic effects, including depressed body weight gains and feed consumption, were observed at 49.8 mg/kg and 74.7 mg/kg. A significant increase in the number of visceral anomalies were observed at 74.7 mg/kg, which were likely due to maternal toxicity. No teratogenic effects on fetuses attributed to the test material could be verified. The NOAEL and LOAEL for maternal toxi- city were 33.4 mg/kg bw/d and 49.8 mg/kg bw/d, respectively; the NOAEL and LOAEL for embryotoxicity were 49.8 mg/kg bw/d and 74.7 mg/kg bw/d, respectively. Genotoxicity Methylisothiazolinone (up to 1000 mg/plate) and the metabolite NMMA (up to 5000 mg/plate) were not mutagenic in the Ames test when tested with and without metabolic activation. In a Chinese hamster ovary (CHO) cell assay, 97.5% pure Methy- lisothiazolinone was nonmutagenic when tested with and with- out metabolic activation (0.5-40.0 mg/mL). However, another CHO assay that studied Methylisothiazolinone at 97.5% ai (0.0785-5000 mg/mL) found significant increases in cells...","endpoint":"developmental toxicity","ingredient":"Methylisothiazolinone","loael_value":"33.4 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"49.8","page":6,"route":"oral","species":"","study_id":"PRS821_noael_008"} |
| UnifiedCodex:CIR:beta.noael_studies | inhalation toxicity | 0.34 | mg/m3 | rat | inhalation | - | inhalation toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=0.34; DOSE=Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight.; EFFECT=as paints, cleaners, and plastics. In April 2020, the US Environmental Protection Agency (EPA) released a draft risk assessment for MCI/MI.14 Included were data and analyses of residential and occupational handler risks to inhalation of spray products containing Methylisothiazolinone and Methylisothiazolinone-preserved paints. Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight. The human equivalent concentrations for MCI/MI, derived from a no-observed-adverse-effect-concentration (NOAEC) of 0.34 mg/m3 (inhalation) in rats, are calculated to be 0.11 and 0.038 mg/m3, based upon an 8-hour and 24-hour time weighted average exposure period, respectively. The inhalation margins of exposure (MOEs) for residential Methylisothiazolinone aerosol and vapor exposures range from 1.0 to 14000, and the inhalation MOEs for occupational Methylisothiazolinone aerosol and vapor exposures range from 0.5 to 5800. Toxico- logical concern was noted when these values were less than the level of concern (LOC) of 10. Scenarios for...; CITATION=14; 2; 400; CITATION_NUMBERS=[14,2,400]; REFERENCE=14; 2; 400; DETAILS_JSON={"cas_number":"2682-20-4","citation":"14; 2; 400","dose":"Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight.","duration":"","effect":"as paints, cleaners, and plastics. In April 2020, the US Environmental Protection Agency (EPA) released a draft risk assessment for MCI/MI.14 Included were data and analyses of residential and occupational handler risks to inhalation of spray products containing Methylisothiazolinone and Methylisothiazolinone-preserved paints. Inhalation risks to these 2 groups were assessed using the Methylisothiazolinone maximum application rate of 400 ppm by weight. The human equivalent concentrations for MCI/MI, derived from a no-observed-adverse-effect-concentration (NOAEC) of 0.34 mg/m3 (inhalation) in rats, are calculated to be 0.11 and 0.038 mg/m3, based upon an 8-hour and 24-hour time weighted average exposure period, respectively. The inhalation margins of exposure (MOEs) for residential Methylisothiazolinone aerosol and vapor exposures range from 1.0 to 14000, and the inhalation MOEs for occupational Methylisothiazolinone aerosol and vapor exposures range from 0.5 to 5800. Toxico- logical concern was noted when these values were less than the level of concern (LOC) of 10. Scenarios for...","endpoint":"inhalation toxicity","ingredient":"Methylisothiazolinone","loael_value":"","noael_unit":"mg/m3","noael_value":"0.34","page":3,"route":"inhalation","species":"rat","study_id":"PRS821_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 220 | ppm | rat | oral | Subchronic | repeated dose toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=220; 44; DOSE=al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality.; LOAEL_VALUE=71.2 mg/ kg bw/d; EFFECT=al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality. No further details were provided. Subchronic Toxicity Studies Oral. No toxic effects were observed when 97.5% Methylisothia- zolinone was administered to rats in drinking water for 13 weeks at concentrations of 0, 75, 250, or 1000 ppm.3 Dogs that were fed diets prepared with 51.4% Methylisothiazolinone for 3 months had an NOAEL of 1500 ppm. In a subchronic study, rats fed the metabolites NMMA and malonic acid (MA), up to 220 and 44 ppm in the diet, respectively, for 3 months showed no effects in body weight, food consumption, hematology, clinical chemis- try, urinalysis, ophthalmology, or gross pathologic changes. Bea- gle dogs that received up to 500 ppm NMMA and 100 ppm MA in their diets for 3 months had no systemic toxicity. In a 90-day oral toxicity study performed in accordance with OECD TG 408, groups of 10 male and 10 female Wistar rats received 0, 7.52, 15.05, or 30.09 mg/kg bw Me...; CITATION=71; 2; 97; CITATION_NUMBERS=[71,2,97]; REFERENCE=71; 2; 97; DETAILS_JSON={"cas_number":"2682-20-4","citation":"71; 2; 97","dose":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality.","duration":"Subchronic","effect":"al signs, mortalities, and pathological and histopathological findings; the lowest-observed-adverse-effect level (LOAEL) was 71.2 mg/ kg bw/d in males and females based on lethargy and mortality. No further details were provided. Subchronic Toxicity Studies Oral. No toxic effects were observed when 97.5% Methylisothia- zolinone was administered to rats in drinking water for 13 weeks at concentrations of 0, 75, 250, or 1000 ppm.3 Dogs that were fed diets prepared with 51.4% Methylisothiazolinone for 3 months had an NOAEL of 1500 ppm. In a subchronic study, rats fed the metabolites NMMA and malonic acid (MA), up to 220 and 44 ppm in the diet, respectively, for 3 months showed no effects in body weight, food consumption, hematology, clinical chemis- try, urinalysis, ophthalmology, or gross pathologic changes. Bea- gle dogs that received up to 500 ppm NMMA and 100 ppm MA in their diets for 3 months had no systemic toxicity. In a 90-day oral toxicity study performed in accordance with OECD TG 408, groups of 10 male and 10 female Wistar rats received 0, 7.52, 15.05, or 30.09 mg/kg bw Me...","endpoint":"repeated dose toxicity","ingredient":"Methylisothiazolinone","loael_value":"71.2 mg/ kg bw/d","noael_unit":"ppm","noael_value":"220; 44","page":5,"route":"oral","species":"rat","study_id":"PRS821_noael_003"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 30.09 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=30.09; DOSE=The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity.; EFFECT=ty, number, and morphology (results reported in the section below). Terminal studies included mea- suring organ weight and relative organ weight, and performing gross pathological and histopathological assessments. No treatment-related mortalities, clinical signs of toxicity, ophthal- mological changes, or changes in feed consumption were observed. There were no significant treatment-related changes in hematological values or clinical chemistry. No significant adverse effects were reported in terminal studies. The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity. Inhalation. While there are no published inhalation data on Methylisothiazolinone, a 13-week repeated-dose inhalation study on MCI/MI was performed in accordance with OECD TG 413.15 Groups of 16 Crl: CD(SD)BR rats per sex were exposed to 14% MCI/MI (11% MCI/3% MI). The rats were exposed whole body for 6 h/d, 5 d/wk, at aerosol Table 2. Acute Toxicity of Methylisothiazolinone. Concentration Dose Species/Strain Method Results Reference Dermal 49.0%; no veh...; CITATION=30; 09; 13; CITATION_NUMBERS=[30,9,13]; REFERENCE=30; 09; 13; DETAILS_JSON={"cas_number":"2682-20-4","citation":"30; 09; 13","dose":"The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity.","duration":"13-week","effect":"ty, number, and morphology (results reported in the section below). Terminal studies included mea- suring organ weight and relative organ weight, and performing gross pathological and histopathological assessments. No treatment-related mortalities, clinical signs of toxicity, ophthal- mological changes, or changes in feed consumption were observed. There were no significant treatment-related changes in hematological values or clinical chemistry. No significant adverse effects were reported in terminal studies. The NOAEL was 30.09 mg/kg bw/d in males and females based on no treatment-related mortality or clinical signs of toxicity. Inhalation. While there are no published inhalation data on Methylisothiazolinone, a 13-week repeated-dose inhalation study on MCI/MI was performed in accordance with OECD TG 413.15 Groups of 16 Crl: CD(SD)BR rats per sex were exposed to 14% MCI/MI (11% MCI/3% MI). The rats were exposed whole body for 6 h/d, 5 d/wk, at aerosol Table 2. Acute Toxicity of Methylisothiazolinone. Concentration Dose Species/Strain Method Results Reference Dermal 49.0%; no veh...","endpoint":"repeated dose toxicity","ingredient":"Methylisothiazolinone","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30.09","page":5,"route":"oral","species":"rat","study_id":"PRS821_noael_004"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 10 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=10; DOSE=The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.; EFFECT=t necropsy had red areas in the glandular portion of the stomach and lungs. No treatment-related effects were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied i...; CITATION=20; 40; 3, 10; CITATION_NUMBERS=[20,40,3,10]; REFERENCE=20; 40; 3, 10; DETAILS_JSON={"cas_number":"2682-20-4","citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","duration":"90-day","effect":"t necropsy had red areas in the glandular portion of the stomach and lungs. No treatment-related effects were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied i...","endpoint":"repeated dose toxicity","ingredient":"Methylisothiazolinone","loael_value":"","noael_unit":"mg/kg/d","noael_value":"10","page":6,"route":"oral","species":"rat","study_id":"PRS821_noael_005"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 30 | mg/kg/d | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=PRS821; REPORT_TITLE=Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics Christina L. Burnett*, Wilma F. Bergfeld**, Donald V. Belsito**, David Cohen**, Curtis D. Klaassen**, Daniel C. Liebler**, James G. Marks, Jr***, Lisa A. Peterson**, Ro; OPINION_NUMBER=PRS821; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=1 In 2019; VALUE_TEXT=30; DOSE=The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.; EFFECT=s were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied in Wistar rats in accordance with OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7...; CITATION=20; 40; 3, 10; CITATION_NUMBERS=[20,40,3,10]; REFERENCE=20; 40; 3, 10; DETAILS_JSON={"cas_number":"2682-20-4","citation":"20; 40; 3, 10","dose":"The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively.","duration":"90-day","effect":"s were observed in the fetuses. The maternal and developmental NOAELs were 20 and 40 mg/kg/d, respectively. In a teratogenicity study of Methyli- sothiazolinone in rabbits, pregnant females received daily sin- gle oral doses of 3, 10, or 30 mg/kg/d Methylisothiazolinone on gestation days 6 to 28. Maternal effects in the 30 mg/kg/d group included decreased defecation and dark red areas in the stomach. The maternal NOAEL was 10 mg/kg/d. No treatment-related effects were observed in the fetuses, and the developmental NOAEL was determined to be 30 mg/kg/d. A 2 generation reproduction toxicity test found that Methylisothia- zolinone in drinking water at concentrations up to 1000 ppm was not a reproductive toxicant.3 In the 90-day oral toxicity study described above, no adverse effects were observed on the male rat reproductive system after Wistar rats received up to 30.09 mg/kg bw Methylisothiazoli- none in water.5 The teratogenic potential of 49.8% Methylisothiazolinone was studied in Wistar rats in accordance with OECD TG 414.5 Groups of 25 pregnant rats received 33.4, 49.8, or 74.7...","endpoint":"repeated dose toxicity","ingredient":"Methylisothiazolinone","loael_value":"","noael_unit":"mg/kg/d","noael_value":"30","page":6,"route":"oral","species":"rat","study_id":"PRS821_noael_006"} |
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 19 | mg/kg bw | rat | oral | 90 day | - | SOURCE_SUBDIR=out270_en; REPORT_TITLE=OPINION CONCERNING METHYLISOTHIAZOLINONE COLIPA n° P 94; OPINION_NUMBER=SCCNFP/0805/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=19; DOSE=No observed adverse effect level (rat, 90 day, drinking water) | NOAEL | = | 19 mg/kg bw; EFFECT=(Methylisothiazolinone) (Preservatives): No observed adverse effect level (rat, 90 day, drinking water) | NOAEL | = | 19 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2682-20-4","citation":"","dose":"No observed adverse effect level (rat, 90 day, drinking water) | NOAEL | = | 19 mg/kg bw","duration":"90 day","effect":"(Methylisothiazolinone) (Preservatives): No observed adverse effect level (rat, 90 day, drinking water) | NOAEL | = | 19 mg/kg bw","endpoint":"","ingredient":"2-Methyl-4-isothiazolin-3-one","loael_value":"","noael_unit":"mg/kg bw","noael_value":"19","page":9,"route":"oral","species":"rat","study_id":"out270_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =19 | mg/kg bw | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=out270_en; REPORT_TITLE=OPINION CONCERNING METHYLISOTHIAZOLINONE COLIPA n° P 94; OPINION_NUMBER=SCCNFP/0805/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 19; DOSE=_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :; EFFECT=_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2682-20-4","citation":"","dose":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","duration":"90 day","effect":"_____________________________________________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as","endpoint":"dermal absorption","ingredient":"2-Methyl-4-isothiazolin-3-one","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 19","page":9,"route":"oral","species":"rat","study_id":"out270_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 100 | % | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=out270_en; REPORT_TITLE=OPINION CONCERNING METHYLISOTHIAZOLINONE COLIPA n° P 94; OPINION_NUMBER=SCCNFP/0805/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=100; DOSE=___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :; EFFECT=___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a prese; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2682-20-4","citation":"","dose":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","duration":"90 day","effect":"___________________________________________________ 9 (Methylisothiazolinone) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a prese","endpoint":"dermal absorption","ingredient":"2-Methyl-4-isothiazolin-3-one","loael_value":"","noael_unit":"%","noael_value":"100","page":9,"route":"oral","species":"rat","study_id":"out270_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 100 | % | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=out270_en; REPORT_TITLE=OPINION CONCERNING METHYLISOTHIAZOLINONE COLIPA n° P 94; OPINION_NUMBER=SCCNFP/0805/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=100; DOSE=ne) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :; EFFECT=ne) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a preservative at a maximum concentration of 0.01% (100 ppm) in the finished cosm; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2682-20-4","citation":"","dose":"ne) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone :","duration":"90 day","effect":"ne) (Preservatives) Based on an exposure of 18 g of cosmetic products applied daily, containing at maximum 0.01 % (100 ppm) of Methylisothiazolinone : Maximum amount of ingredient applied I (mg) = 1.8 mg Typical human body weight = 60 kg Maximum absorption through the skin A (%) = 100 % Dermal absorption per treatment I x A = 1.8 mg Systemic exposure dose (SED) I x A / 60 kg = 0.03 mg/kg bw No observed adverse effect level NOAEL = 19 mg/kg bw (rat, 90 day, drinking water) Margin of Safety NOAEL / SED = 633 2.12. Conclusions The requested data provided on physico-chemical properties on methylisothiazolinone are complete. The percutaneous absorption study is inadequate. A 100% absorption is assumed. The in vivo UDS assay is adequate. Methylisothiazolinone is considered non genotoxic/mutagenic. See also doc. n° SCCNFP/0625/02. 2.13. Opinion The SCCNFP is of the opinion that the proposed use of Methylisothiazolinone as a preservative at a maximum concentration of 0.01% (100 ppm) in the finished cosm","endpoint":"dermal absorption","ingredient":"2-Methyl-4-isothiazolin-3-one","loael_value":"","noael_unit":"%","noael_value":"100","page":9,"route":"oral","species":"rat","study_id":"out270_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 250 | ppm | - | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out_201; REPORT_TITLE=OPINION CONCERNING METHYLISOTHIAZOLINONE COLIPA n° P94; OPINION_NUMBER=SCCNFP/0625/02; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=250; DOSE=d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing.; EFFECT=d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing. Haematology and clinical chemistry revealed no treatment-related changes in either sex at any dose level. There were no treatment-related gross or microscopic pathological findings at any dose level in either sex. Based on effects on body weight and feed consumption at 1000 ppm (65.7 and 93.5 mg a.i./kg bw/day in males and females respectively) the NOAEL in this study was 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg bw/day in males and females, respectively). Ref. : 4 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data; CITATION=Ref. : 4 2; CITATION_NUMBERS=[4,2]; REFERENCE=Ref. : 4 2; DETAILS_JSON={"cas_number":"2682-20-4","citation":"Ref. : 4 2","dose":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing.","duration":"Sub-chronic","effect":"d decreases in water consumption in female animals exposed to 250 and 1000 ppm throughout most of the dosing phase and in males at all exposure doses throughout dosing. Haematology and clinical chemistry revealed no treatment-related changes in either sex at any dose level. There were no treatment-related gross or microscopic pathological findings at any dose level in either sex. Based on effects on body weight and feed consumption at 1000 ppm (65.7 and 93.5 mg a.i./kg bw/day in males and females respectively) the NOAEL in this study was 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg bw/day in males and females, respectively). Ref. : 4 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","endpoint":"repeated dose toxicity","ingredient":"in","loael_value":"","noael_unit":"ppm","noael_value":"250","page":7,"route":"oral","species":"","study_id":"out_201_noael_001"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | sensitisation | 15 | µg/cm2 | - | - | - | sensitisation | SOURCE_SUBDIR=sccs_o_178; REPORT_TITLE=Final Opinion December 2015 Scientific Committee on Consumer Safety SCCS OPINION ON Methylisothiazolinone (MI) (P94); OPINION_NUMBER=SCCS/1557/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=15; DOSE=Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water;; EFFECT=SCCS/1557/15 Final Opinion on Methylisothiazolinone (MI) (P94), submission III, sensitisation only 13 Taking all of the data together, since the HRIPT threshold is the lowest no observed effect level (NOEL) available, it shall, according to the submission, take precedence in deriving the NESIL for use in the QRA. Therefore, the WoE NESIL for MI is 15µg/cm2. A summary of the considered HRIPT studies (26) conducted on MI is given in the submission as table 2 and reproduced below: Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water; 0.2ml, 4 cm2 200ppm (10 µg/cm2) 200ppm 0 / 100 Water; 0.2ml, 4 cm2 300ppm (15 µg/cm2) 300ppm 0 / 98 Water; 0.2ml, 4 cm2 400pp; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2682-20-4","citation":"","dose":"Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water;","duration":"","effect":"SCCS/1557/15 Final Opinion on Methylisothiazolinone (MI) (P94), submission III, sensitisation only 13 Taking all of the data together, since the HRIPT threshold is the lowest no observed effect level (NOEL) available, it shall, according to the submission, take precedence in deriving the NESIL for use in the QRA. Therefore, the WoE NESIL for MI is 15µg/cm2. A summary of the considered HRIPT studies (26) conducted on MI is given in the submission as table 2 and reproduced below: Vehicle, Dose Volume, Patch Size Induction Concentration (ug/cm2) Challenge Concentration Positive Responses Water; 0.2ml, 4 cm2 200ppm (10 µg/cm2) 200ppm 0 / 100 Water; 0.2ml, 4 cm2 300ppm (15 µg/cm2) 300ppm 0 / 98 Water; 0.2ml, 4 cm2 400pp","endpoint":"sensitisation","ingredient":", an in vitro percutaneous","loael_value":"","noael_unit":"µg/cm2","noael_value":"15","page":13,"route":"","species":"","study_id":"sccs_o_178_noael_001"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 229D0E1QFA | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"229D0E1QFA"} |
| openFDA substances | FDA UNII substance identifier | 229D0E1QFA | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"229D0E1QFA"} |
| openFDA substances | FDA UNII substance identifier | 229D0E1QFA | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"229D0E1QFA"} |
| openFDA substances | FDA UNII substance identifier | 229D0E1QFA | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"229D0E1QFA"} |