| Regulatory source |
- |
10 |
mg/kg bw/d |
rabbit |
intravenous |
30 days |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=5 female animals per dose Test substance: chloroacetamide Batch: no information Purity: no information Dose:; EFFECT=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 18 NOAEL (sc): 10 mg/kg bw/d. Ref.: AR 56 Intravenous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test substance: chloroacetamide Batch: no information Purity: no information Dose: 2, 10, 25, 50, 100 mg/kg bw/d Controls: 0.9% saline Route: intravenous Duration: 30 days GLP: no Study period: 1967 Chloroacetamide was administered intravenously for 30 consecutive days to female rabbits at dose levels of 2, 10, 25, 50 and 100 mg/kg bw/d. In control an; CITATION=Ref.: AR 56 Intravenous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test substance: chloroacetamide Batch: no inf; CITATION_NUMBERS=[56,5]; REFERENCE=Ref.: AR 56 Intravenous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test substance: chloroacetamide Batch: no inf; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 56 Intravenous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test substance: chloroacetamide Batch: no inf","dose":"5 female animals per dose Test substance: chloroacetamide Batch: no information Purity: no information Dose:","duration":"30 days","effect":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 18 NOAEL (sc): 10 mg/kg bw/d. Ref.: AR 56 Intravenous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test substance: chloroacetamide Batch: no information Purity: no information Dose: 2, 10, 25, 50, 100 mg/kg bw/d Controls: 0.9% saline Route: intravenous Duration: 30 days GLP: no Study period: 1967 Chloroacetamide was administered intravenously for 30 consecutive days to female rabbits at dose levels of 2, 10, 25, 50 and 100 mg/kg bw/d. In control an","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":18,"route":"intravenous","species":"rabbit","study_id":"sccs_o_053_noael_005"} |
| Regulatory source |
- |
10 |
mg/kg bw/day |
rat |
oral |
90 d |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 20 sexes. In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed. A NOAEL of 10 mg/kg bw/day was derived from this study. Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12.5.mg/kg bw/d). Thus, for calculation of the MoS based on oral exposure, the NOAEL of 10 mg/kg bw/d is taken. In a further, non-GLP-compliant study (the original study report was not available for evaluation) using groups of 20 Wistar rats (no further information on substance and whether bo; CITATION=Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12; CITATION_NUMBERS=[54,90,12]; REFERENCE=Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12","dose":"In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed.","duration":"90 d","effect":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 20 sexes. In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed. A NOAEL of 10 mg/kg bw/day was derived from this study. Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12.5.mg/kg bw/d). Thus, for calculation of the MoS based on oral exposure, the NOAEL of 10 mg/kg bw/d is taken. In a further, non-GLP-compliant study (the original study report was not available for evaluation) using groups of 20 Wistar rats (no further information on substance and whether bo","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/day","noael_value":"10","page":20,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_007"} |
| Regulatory source |
- |
10 |
mg/kg bw/d |
rat |
oral |
90 d |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=loroacetamide ___________________________________________________________________________________________ 20 sexes. In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed. A NOAEL of 10 mg/kg bw/day was derived from this study. Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12.5.mg/kg bw/d). Thus, for calculation of the MoS based on oral exposure, the NOAEL of 10 mg/kg bw/d is taken. In a further, non-GLP-compliant study (the original study report was not available for evaluation) using groups of 20 Wistar rats (no further information on substance and whether both sexes of animals were used), dosages 0, 12.5 and 50.0 mg/kg bw/d were administered via diet for a period of 13 weeks. At 12.5 mg/kg bw/d, reduction of testes sizes and impaired spermiogenesis was reported. At the high dose (50 mg/kg bw/d), body weight gain and scrubby fur were observed in addition to redu; CITATION=Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12; CITATION_NUMBERS=[54,90,12]; REFERENCE=Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12","dose":"In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed.","duration":"90 d","effect":"loroacetamide ___________________________________________________________________________________________ 20 sexes. In groups receiving 2 and 10 mg/kg bw/d, no substance-related organ changes were observed. A NOAEL of 10 mg/kg bw/day was derived from this study. Ref.: AR 54 Comment This study was aimed at identifying a dose without effect, which could not be established in a previous oral 90 d study (the study resulting in a LOAEL of 12.5.mg/kg bw/d). Thus, for calculation of the MoS based on oral exposure, the NOAEL of 10 mg/kg bw/d is taken. In a further, non-GLP-compliant study (the original study report was not available for evaluation) using groups of 20 Wistar rats (no further information on substance and whether both sexes of animals were used), dosages 0, 12.5 and 50.0 mg/kg bw/d were administered via diet for a period of 13 weeks. At 12.5 mg/kg bw/d, reduction of testes sizes and impaired spermiogenesis was reported. At the high dose (50 mg/kg bw/d), body weight gain and scrubby fur were observed in addition to redu","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"10","page":20,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_008"} |
| Regulatory source |
- |
10 |
mg/kg bw/d |
rat |
oral |
13 week |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=These events are key events in the formation of cell damage and of morphological changes in the liver of animals treated i.p. with chloroacetamide.; EFFECT=in vivo. Ref.: AR 16 Summary on special investigations In one in vitro and two in vivo studies it was demonstrated that chloroacetamide caused glutathione depletion and lipid peroxidation. These events are key events in the formation of cell damage and of morphological changes in the liver of animals treated i.p. with chloroacetamide. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Chloroacetamide (I) MoS calculation based on an oral 13 week study in rats. NOAEL: 10 mg/kg bw/d based on testis effects in male animals and enlarged thyroids in female animals An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance (2011). Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/10; CITATION=Ref.: AR 16 Summary on special investigations In one in vitro and two in vivo studies it was demonstrated that chloroacetamide caused glutathione depletion and lipid peroxidation; CITATION_NUMBERS=[16]; REFERENCE=Ref.: AR 16 Summary on special investigations In one in vitro and two in vivo studies it was demonstrated that chloroacetamide caused glutathione depletion and lipid peroxidation; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 16 Summary on special investigations In one in vitro and two in vivo studies it was demonstrated that chloroacetamide caused glutathione depletion and lipid peroxidation","dose":"These events are key events in the formation of cell damage and of morphological changes in the liver of animals treated i.p. with chloroacetamide.","duration":"13 week","effect":"in vivo. Ref.: AR 16 Summary on special investigations In one in vitro and two in vivo studies it was demonstrated that chloroacetamide caused glutathione depletion and lipid peroxidation. These events are key events in the formation of cell damage and of morphological changes in the liver of animals treated i.p. with chloroacetamide. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Chloroacetamide (I) MoS calculation based on an oral 13 week study in rats. NOAEL: 10 mg/kg bw/d based on testis effects in male animals and enlarged thyroids in female animals An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance (2011). Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/10","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":37,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_016"} |
| Regulatory source |
- |
=10 |
mg/kg bw/d |
rat |
oral |
13 week |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 10; DOSE=Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13...; EFFECT=and enlarged thyroids in female animals An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance (2011). Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13 week oral rat study) MOS NOAEL/SED = 21; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13...","duration":"13 week","effect":"and enlarged thyroids in female animals An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance (2011). Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13 week oral rat study) MOS NOAEL/SED = 21","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 10","page":37,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_017"} |
| Regulatory source |
- |
=10 |
mg/kg bw/d |
rat |
oral |
13 week |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 10; DOSE=Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13...; EFFECT=e value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance (2011). Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13 week oral rat study) MOS NOAEL/SED = 21; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13...","duration":"13 week","effect":"e value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance (2011). Absorption through the skin DAp (%) = 56% Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.3% Typical body weight of human = 60 kg Systemic exposure dose (SED) = 0.4872 A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 No adverse observed effect level NOAEL = 10 mg/kg bw/d (13 week oral rat study) MOS NOAEL/SED = 21","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 10","page":37,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_018"} |
| Regulatory source |
- |
20 |
- |
rabbit |
oral |
30 day |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=unclear:in) received 20 applications of 0, 5, 10 and 20 mg/l chloroacetamide. No further information on substance was given. Behaviour and haemogram were normal. At the highest dose, protein was present in the urine. Further, dose-dependent degenerative macroscopic and histological changes in livers and kidneys could be observed. Ref.: AR 48 Comment The original study report was not available for evaluation. Therefore it cannot be checked whether the unit of mg/l which is given for dosage, is correct or a typing error. A NOAEL cannot be derived from this study description, the study can only be used as supporting information. Further information on oral short-term repeat-dose studies which lack information on dosages is available. In a 30 day oral study in rabbits, spastic paralysis with or without sensory change was observed. Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description. Therefore it can only be used as supporting information. Dermal Guideline: precedes OECD test; DOSE=At the highest dose, protein was present in the urine.; EFFECT=in) received 20 applications of 0, 5, 10 and 20 mg/l chloroacetamide. No further information on substance was given. Behaviour and haemogram were normal. At the highest dose, protein was present in the urine. Further, dose-dependent degenerative macroscopic and histological changes in livers and kidneys could be observed. Ref.: AR 48 Comment The original study report was not available for evaluation. Therefore it cannot be checked whether the unit of mg/l which is given for dosage, is correct or a typing error. A NOAEL cannot be derived from this study description, the study can only be used as supporting information. Further information on oral short-term repeat-dose studies which lack information on dosages is available. In a 30 day oral study in rabbits, spastic paralysis with or without sensory change was observed. Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description. Therefore it can only be used as supporting information. Dermal Guideline: precedes OECD test; CITATION=Ref.: AR 48 Comment The original study report was not available for evaluation; CITATION_NUMBERS=[48]; REFERENCE=Ref.: AR 48 Comment The original study report was not available for evaluation; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 48 Comment The original study report was not available for evaluation","dose":"At the highest dose, protein was present in the urine.","duration":"30 day","effect":"in) received 20 applications of 0, 5, 10 and 20 mg/l chloroacetamide. No further information on substance was given. Behaviour and haemogram were normal. At the highest dose, protein was present in the urine. Further, dose-dependent degenerative macroscopic and histological changes in livers and kidneys could be observed. Ref.: AR 48 Comment The original study report was not available for evaluation. Therefore it cannot be checked whether the unit of mg/l which is given for dosage, is correct or a typing error. A NOAEL cannot be derived from this study description, the study can only be used as supporting information. Further information on oral short-term repeat-dose studies which lack information on dosages is available. In a 30 day oral study in rabbits, spastic paralysis with or without sensory change was observed. Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description. Therefore it can only be used as supporting information. Dermal Guideline: precedes OECD test","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"","noael_value":"unclear:in) received 20 applications of 0, 5, 10 and 20 mg/l chloroacetamide. No further information on substance was given. Behaviour and haemogram were normal. At the highest dose, protein was present in the urine. Further, dose-dependent degenerative macroscopic and histological changes in livers and kidneys could be observed. Ref.: AR 48 Comment The original study report was not available for evaluation. Therefore it cannot be checked whether the unit of mg/l which is given for dosage, is correct or a typing error. A NOAEL cannot be derived from this study description, the study can only be used as supporting information. Further information on oral short-term repeat-dose studies which lack information on dosages is available. In a 30 day oral study in rabbits, spastic paralysis with or without sensory change was observed. Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description. Therefore it can only be used as supporting information. Dermal Guideline: precedes OECD test","page":16,"route":"oral","species":"rabbit","study_id":"sccs_o_053_noael_001"} |
| Regulatory source |
- |
40 |
% |
rabbit |
oral |
30 day |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=40; DOSE=Further information on oral short-term repeat-dose studies which lack information on dosages is available.; EFFECT=t available for evaluation. Therefore it cannot be checked whether the unit of mg/l which is given for dosage, is correct or a typing error. A NOAEL cannot be derived from this study description, the study can only be used as supporting information. Further information on oral short-term repeat-dose studies which lack information on dosages is available. In a 30 day oral study in rabbits, spastic paralysis with or without sensory change was observed. Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description. Therefore it can only be used as supporting information. Dermal Guideline: precedes OECD test guidelines Species: rabbit, Yellow-Silver, weighing between 1.6 and 2.9 kg Group: 5 female animals per dose Test substance: chloroacetamide, 40% aqueous suspension Batch: no information Purity: no information Dose: 25, 50, 100, 200, 400 mg/kg bw/d (dose levels refer to chloroacetamide) Controls: 0 mg chloroacetamide Route: dermal Duration: 30 days, one application per day G; CITATION=Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description; CITATION_NUMBERS=[38]; REFERENCE=Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description","dose":"Further information on oral short-term repeat-dose studies which lack information on dosages is available.","duration":"30 day","effect":"t available for evaluation. Therefore it cannot be checked whether the unit of mg/l which is given for dosage, is correct or a typing error. A NOAEL cannot be derived from this study description, the study can only be used as supporting information. Further information on oral short-term repeat-dose studies which lack information on dosages is available. In a 30 day oral study in rabbits, spastic paralysis with or without sensory change was observed. Ref.: AR 38 Comment As no information on dose is available, a NOAEL cannot be derived from the study description. Therefore it can only be used as supporting information. Dermal Guideline: precedes OECD test guidelines Species: rabbit, Yellow-Silver, weighing between 1.6 and 2.9 kg Group: 5 female animals per dose Test substance: chloroacetamide, 40% aqueous suspension Batch: no information Purity: no information Dose: 25, 50, 100, 200, 400 mg/kg bw/d (dose levels refer to chloroacetamide) Controls: 0 mg chloroacetamide Route: dermal Duration: 30 days, one application per day G","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"%","noael_value":"40","page":16,"route":"oral","species":"rabbit","study_id":"sccs_o_053_noael_002"} |
| Regulatory source |
- |
50 |
mg/kg bw/ d |
rat |
dermal |
30 day |
- |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=50; DOSE=50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance.; EFFECT=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 38 (II) MoS calculation based on a dermal 30 day study in rats NOAEL: 50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance.","duration":"30 day","effect":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 38 (II) MoS calculation based on a dermal 30 day study in rats NOAEL: 50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacu","endpoint":"","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/ d","noael_value":"50","page":38,"route":"dermal","species":"rat","study_id":"sccs_o_053_noael_019"} |
| Regulatory source |
dermal absorption |
50 |
mg/kg bw/d |
- |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=50; DOSE=ological findings were not observed in the two lowest dose groups.; EFFECT=ological findings were not observed in the two lowest dose groups. Above 100 mg/kg bw/d, dose-dependent weight loss and dose-dependent histopathological changes of liver, heart and spleen could be observed. The highest dose level was lethal in 3 of 5 animals. Local changes as well as histopathological changes in liver, kidney and spleen were more pronounced in the highest dose group compared to the lower dose groups. Analysis of blood and urine revealed no pathological findings in any of the dose groups. A dermal NOAEL of 50 mg/kg bw/d was derived from this study based on weight loss and histopathological changes of liver, heart and spleen. This dermal NOAEL of 50 mg/kg bw/d is taken for MoS calculation. Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place. Although the study was performed prior to the implementation of OECD testguidelines and GLP principles it has been properly performed and documented and is considered as a valid study for the assessment of repeated dermal toxicity; CITATION=Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place; CITATION_NUMBERS=[55]; REFERENCE=Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place","dose":"ological findings were not observed in the two lowest dose groups.","duration":"","effect":"ological findings were not observed in the two lowest dose groups. Above 100 mg/kg bw/d, dose-dependent weight loss and dose-dependent histopathological changes of liver, heart and spleen could be observed. The highest dose level was lethal in 3 of 5 animals. Local changes as well as histopathological changes in liver, kidney and spleen were more pronounced in the highest dose group compared to the lower dose groups. Analysis of blood and urine revealed no pathological findings in any of the dose groups. A dermal NOAEL of 50 mg/kg bw/d was derived from this study based on weight loss and histopathological changes of liver, heart and spleen. This dermal NOAEL of 50 mg/kg bw/d is taken for MoS calculation. Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place. Although the study was performed prior to the implementation of OECD testguidelines and GLP principles it has been properly performed and documented and is considered as a valid study for the assessment of repeated dermal toxicity","endpoint":"dermal absorption","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":17,"route":"dermal","species":"","study_id":"sccs_o_053_noael_003"} |
| Regulatory source |
dermal absorption |
50 |
mg/kg bw/d |
rabbit |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=50; DOSE=The highest dose level was lethal in 3 of 5 animals.; EFFECT=thological changes of liver, heart and spleen could be observed. The highest dose level was lethal in 3 of 5 animals. Local changes as well as histopathological changes in liver, kidney and spleen were more pronounced in the highest dose group compared to the lower dose groups. Analysis of blood and urine revealed no pathological findings in any of the dose groups. A dermal NOAEL of 50 mg/kg bw/d was derived from this study based on weight loss and histopathological changes of liver, heart and spleen. This dermal NOAEL of 50 mg/kg bw/d is taken for MoS calculation. Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place. Although the study was performed prior to the implementation of OECD testguidelines and GLP principles it has been properly performed and documented and is considered as a valid study for the assessment of repeated dermal toxicity. Subcutaneous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test su; CITATION=Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place; CITATION_NUMBERS=[55]; REFERENCE=Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place","dose":"The highest dose level was lethal in 3 of 5 animals.","duration":"","effect":"thological changes of liver, heart and spleen could be observed. The highest dose level was lethal in 3 of 5 animals. Local changes as well as histopathological changes in liver, kidney and spleen were more pronounced in the highest dose group compared to the lower dose groups. Analysis of blood and urine revealed no pathological findings in any of the dose groups. A dermal NOAEL of 50 mg/kg bw/d was derived from this study based on weight loss and histopathological changes of liver, heart and spleen. This dermal NOAEL of 50 mg/kg bw/d is taken for MoS calculation. Ref.: AR 55 Comment This study demonstrates that dermal absorption of chloroacetamide takes place. Although the study was performed prior to the implementation of OECD testguidelines and GLP principles it has been properly performed and documented and is considered as a valid study for the assessment of repeated dermal toxicity. Subcutaneous Guideline: precedes OECD test guidelines Species: rabbit (no information on strain) Group: 5 female animals per dose Test su","endpoint":"dermal absorption","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":17,"route":"dermal","species":"rabbit","study_id":"sccs_o_053_noael_004"} |
| Regulatory source |
genotoxicity |
10 |
mg/kg bw/d |
- |
oral |
- |
genotoxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies.; LOAEL_VALUE=12.5 mg/kg bw/d; EFFECT=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. From repeat-dose studies available, an oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d were taken for two possibilities of MOS calculation. Mutagenicity In vitro, chloroacetamide was non-mutagenic in three Salmonella assays using S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and in a gene mutation test using Syrian hamster embryo cells (with and without metabolic activation, respectively). One bacterial in vitro fluctuation test using Klebsiella pneumoniae yielded positive results. In vivo, negative results were obtained in a Chinese ham; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies.","duration":"","effect":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. From repeat-dose studies available, an oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d were taken for two possibilities of MOS calculation. Mutagenicity In vitro, chloroacetamide was non-mutagenic in three Salmonella assays using S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and in a gene mutation test using Syrian hamster embryo cells (with and without metabolic activation, respectively). One bacterial in vitro fluctuation test using Klebsiella pneumoniae yielded positive results. In vivo, negative results were obtained in a Chinese ham","endpoint":"genotoxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"12.5 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"","study_id":"sccs_o_053_noael_025"} |
| Regulatory source |
genotoxicity |
50 |
mg/kg bw/d |
- |
oral |
- |
genotoxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=50; DOSE=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies.; LOAEL_VALUE=12.5 mg/kg bw/d; EFFECT=SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. From repeat-dose studies available, an oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d were taken for two possibilities of MOS calculation. Mutagenicity In vitro, chloroacetamide was non-mutagenic in three Salmonella assays using S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and in a gene mutation test using Syrian hamster embryo cells (with and without metabolic activation, respectively). One bacterial in vitro fluctuation test using Klebsiella pneumoniae yielded positive results. In vivo, negative results were obtained in a Chinese hamster chromosome aberration test exam; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies.","duration":"","effect":"SCCS/1360/10 Opinion on chloroacetamide ___________________________________________________________________________________________ 40 LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. From repeat-dose studies available, an oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d were taken for two possibilities of MOS calculation. Mutagenicity In vitro, chloroacetamide was non-mutagenic in three Salmonella assays using S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and in a gene mutation test using Syrian hamster embryo cells (with and without metabolic activation, respectively). One bacterial in vitro fluctuation test using Klebsiella pneumoniae yielded positive results. In vivo, negative results were obtained in a Chinese hamster chromosome aberration test exam","endpoint":"genotoxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"12.5 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"50","page":40,"route":"oral","species":"","study_id":"sccs_o_053_noael_026"} |
| Regulatory source |
repeated dose toxicity |
10 |
mg/kg bw/d |
rat |
oral |
Sub-chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=At 50 mg/kg bw/d, all animals died after 6 to 15 injections.; EFFECT=b paralysis starting after injection 13, diarrhoea, body weight loss and a slight reduction in haemoglobin were reported. Organs were without histopathological findings. At 50 mg/kg bw/d, all animals died after 6 to 15 injections. Limb paralysis starting after injection 7 and diarrhoea were reported. Laboratory tests were not performed. Organs were without histopathological findings. At 100 mg/kg bw/d, all animals died after one or two injections, laboratory tests or post-mortem investigations were not performed. NOAEL (iv): 10 mg/kg bw/d Ref.: AR 57 Intraperitoneal Repeated i.p. administrations of 37.5 mg/kg bw chloroacetamide every second day to male Sprague-Dawley rats induced slight hepatocellular swelling and hydropic degeneration in the peripheral two-thirds of the lobules of the liver within two weeks. Ref.: AR 6 3.3.5.2. Sub-chronic (90 days) oral / dermal Oral Guideline: no information Species: rat (Sprague-Dawley) Group: 10 animals / sex / dose Test substance: chloroacetamide Batch: no information Purity: no info; CITATION=Ref.: AR 57 Intraperitoneal Repeated i; CITATION_NUMBERS=[57]; REFERENCE=Ref.: AR 57 Intraperitoneal Repeated i; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 57 Intraperitoneal Repeated i","dose":"At 50 mg/kg bw/d, all animals died after 6 to 15 injections.","duration":"Sub-chronic","effect":"b paralysis starting after injection 13, diarrhoea, body weight loss and a slight reduction in haemoglobin were reported. Organs were without histopathological findings. At 50 mg/kg bw/d, all animals died after 6 to 15 injections. Limb paralysis starting after injection 7 and diarrhoea were reported. Laboratory tests were not performed. Organs were without histopathological findings. At 100 mg/kg bw/d, all animals died after one or two injections, laboratory tests or post-mortem investigations were not performed. NOAEL (iv): 10 mg/kg bw/d Ref.: AR 57 Intraperitoneal Repeated i.p. administrations of 37.5 mg/kg bw chloroacetamide every second day to male Sprague-Dawley rats induced slight hepatocellular swelling and hydropic degeneration in the peripheral two-thirds of the lobules of the liver within two weeks. Ref.: AR 6 3.3.5.2. Sub-chronic (90 days) oral / dermal Oral Guideline: no information Species: rat (Sprague-Dawley) Group: 10 animals / sex / dose Test substance: chloroacetamide Batch: no information Purity: no info","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":18,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_006"} |
| Regulatory source |
repeated dose toxicity |
10 |
mg /kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=ection 3.3.8.2 Teratogenicity), where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.; LOAEL_VALUE=12.5 mg/kg bw/d; EFFECT=ection 3.3.8.2 Teratogenicity), where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. An oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d are used for two possibilities of MOS calculation. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of chloroacetamide has been investigated in bacterial assays and in a SHE assay. An overview is given in table 3.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"ection 3.3.8.2 Teratogenicity), where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.","duration":"subchronic","effect":"ection 3.3.8.2 Teratogenicity), where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. An oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d are used for two possibilities of MOS calculation. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of chloroacetamide has been investigated in bacterial assays and in a SHE assay. An overview is given in table 3.","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"12.5 mg/kg bw/d","noael_unit":"mg /kg bw/d","noael_value":"10","page":21,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_010"} |
| Regulatory source |
repeated dose toxicity |
10 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.; LOAEL_VALUE=12.5 mg/kg bw/d; EFFECT=17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. An oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d are used for two possibilities of MOS calculation. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of chloroacetamide has been investigated in bacterial assays and in a SHE assay. An overview is given in table 3.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.","duration":"subchronic","effect":"17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. An oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d are used for two possibilities of MOS calculation. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of chloroacetamide has been investigated in bacterial assays and in a SHE assay. An overview is given in table 3.","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"12.5 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"10","page":21,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_011"} |
| Regulatory source |
repeated dose toxicity |
10 |
mg /kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=In a teratological study where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.; EFFECT=sexes. In a teratological study where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"In a teratological study where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.","duration":"subchronic","effect":"sexes. In a teratological study where Wistar rats received chloroacetamide by gavage from GD 7 to GD 17, reduced thymus weight and shrinking of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg /kg bw/d","noael_value":"10","page":39,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_024"} |
| Regulatory source |
repeated dose toxicity |
=16.6 |
mg/kg bw/d |
rat |
oral |
30 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 16.6; DOSE=50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance.; EFFECT=(II) MoS calculation based on a dermal 30 day study in rats NOAEL: 50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is available from IUCLID data. The purity of technical chloroacetamide is at least 98%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance.","duration":"30 day","effect":"(II) MoS calculation based on a dermal 30 day study in rats NOAEL: 50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is available from IUCLID data. The purity of technical chloroacetamide is at least 98%","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 16.6","page":38,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_021"} |
| Regulatory source |
repeated dose toxicity |
=16.6 |
mg/kg bw/d |
rat |
oral |
30 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 16.6; DOSE=Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and...; EFFECT=pendent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is available from IUCLID data. The purity of technical chloroacetamide is at least 98%. For most studies utilized for this report, the exact specification of the substance cannot be traced back. Also, o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and...","duration":"30 day","effect":"pendent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is available from IUCLID data. The purity of technical chloroacetamide is at least 98%. For most studies utilized for this report, the exact specification of the substance cannot be traced back. Also, o","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 16.6","page":38,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_022"} |
| Regulatory source |
repeated dose toxicity |
=16.6 |
mg/kg bw/d |
rat |
oral |
30 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 16.6; DOSE=Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and...; EFFECT=art and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is available from IUCLID data. The purity of technical chloroacetamide is at least 98%. For most studies utilized for this report, the exact specification of the substance cannot be traced back. Also, only limited information on the methods applied; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and...","duration":"30 day","effect":"art and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is available from IUCLID data. The purity of technical chloroacetamide is at least 98%. For most studies utilized for this report, the exact specification of the substance cannot be traced back. Also, only limited information on the methods applied","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 16.6","page":38,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_023"} |
| Regulatory source |
repeated dose toxicity |
35 |
mg/kg |
- |
oral |
14d |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=35; DOSE=body weight of CA 24 corresponds to 35 mg chloroacetamide/kg body weight and the dose level of 12.5 mg/kg body weight of CA 24 corresponds to 8.75 mg chloroacetamide/kg body weight.; EFFECT=body weight of CA 24 corresponds to 35 mg chloroacetamide/kg body weight and the dose level of 12.5 mg/kg body weight of CA 24 corresponds to 8.75 mg chloroacetamide/kg body weight. No reasons were given for the choice of dosages. The study parameters, which included body weight, feed consumption and histopathological examination of the testis and epididymis, gave no indications of pathological changes attributable to the substance. There are no data on the chemical’s dermatological actions during the treatment. NOAEL: 35 mg/kg/bw (highest dose applied). Ref.: AR 11 Comment The original study report was not available for evaluation. As substantial information (e.g. on the number of applications and on parameters investigated) is lacking, the study will not be used for risk assessment. Summary on repeat-dose toxicity Short-term (14d), subacute (28d/30d) and subchronic (90 d) repeat-dose studies on chloroacetamide have been performed but none of them met modern standards with respect to test guideline compliance and quality a; CITATION=Ref.: AR 11 Comment The original study report was not available for evaluation; CITATION_NUMBERS=[11]; REFERENCE=Ref.: AR 11 Comment The original study report was not available for evaluation; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 11 Comment The original study report was not available for evaluation","dose":"body weight of CA 24 corresponds to 35 mg chloroacetamide/kg body weight and the dose level of 12.5 mg/kg body weight of CA 24 corresponds to 8.75 mg chloroacetamide/kg body weight.","duration":"14d","effect":"body weight of CA 24 corresponds to 35 mg chloroacetamide/kg body weight and the dose level of 12.5 mg/kg body weight of CA 24 corresponds to 8.75 mg chloroacetamide/kg body weight. No reasons were given for the choice of dosages. The study parameters, which included body weight, feed consumption and histopathological examination of the testis and epididymis, gave no indications of pathological changes attributable to the substance. There are no data on the chemical’s dermatological actions during the treatment. NOAEL: 35 mg/kg/bw (highest dose applied). Ref.: AR 11 Comment The original study report was not available for evaluation. As substantial information (e.g. on the number of applications and on parameters investigated) is lacking, the study will not be used for risk assessment. Summary on repeat-dose toxicity Short-term (14d), subacute (28d/30d) and subchronic (90 d) repeat-dose studies on chloroacetamide have been performed but none of them met modern standards with respect to test guideline compliance and quality a","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg","noael_value":"35","page":20,"route":"oral","species":"","study_id":"sccs_o_053_noael_009"} |
| Regulatory source |
repeated dose toxicity |
50 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=50; DOSE=ing of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.; LOAEL_VALUE=12.5 mg/kg bw/d; EFFECT=ing of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. An oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d are used for two possibilities of MOS calculation. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of chloroacetamide has been investigated in bacterial assays and in a SHE assay. An overview is given in table 3.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"ing of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study.","duration":"subchronic","effect":"ing of the thymus was observed in female animals at a dose level of 48 mg/kg bw at termination of the study. A poorly described subchronic dermal study with CA 24 in rats gave no indications of pathological changes attributable to the substance. Effects on the male reproductive system were the most sensitive effects observed in subchronic studies. Based on testis effects, an oral NOAEL of 10 mg /kg bw/d and an oral LOAEL of 12.5 mg/kg bw/d were derived from 90-d studies. An oral NOAEL of 10 mg/kg bw/d and a dermal NOAEL of 50 mg/kg bw/d are used for two possibilities of MOS calculation. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of chloroacetamide has been investigated in bacterial assays and in a SHE assay. An overview is given in table 3.","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"12.5 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"50","page":21,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_012"} |
| Regulatory source |
repeated dose toxicity |
=50 |
mg/kg bw/d |
rat |
oral |
30 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 50; DOSE=50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance.; EFFECT=_____________________________________________________________________________ 38 (II) MoS calculation based on a dermal 30 day study in rats NOAEL: 50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance.","duration":"30 day","effect":"_____________________________________________________________________________ 38 (II) MoS calculation based on a dermal 30 day study in rats NOAEL: 50 mg/kg bw/ d based on systemic effects (dose-dependent histopathological changes in liver, heart and spleen) after dermal administration An aggregate value of 17.4 g/d for the amount of cosmetics applied daily is taken for MoS calculation according to the notes of guidance. Dermal dose = 0.87 A (g/d) x 1000 mg/g x C (%)/100 /60 No adverse observed effect level NOAEL = 50 mg/kg bw/d (30 day dermal rat study) No adverse observed effect level NOAEL = 16.6 mg/kg bw/d (corrected for study duration from subacute to subchronic by a factor of 3) MOS corrected NOAEL/SED = 19 MoS calculations based on the NOAEL from oral and dermal studies lead to an almost equal outcome. 3.3.14. Discussion Physico-chemical properties Chloroacetamide is white crystalline powder which is readily soluble in water and in some organic solvents. Information on impurities and physicochemical data is a","endpoint":"repeated dose toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":38,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_020"} |
| Regulatory source |
reproductive toxicity |
3 |
mg/kg bw/d |
- |
- |
13 weeks |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=3; DOSE=No difference in the number of pups born and number of pups surviving until PND 4 was found between treated and control animals.; EFFECT=between PNDs 0 and 4. No difference in the number of pups born and number of pups surviving until PND 4 was found between treated and control animals. Also with respect to AGD, vaginal opening and preputial separation, there were no differences between treated and control animals. At 13 weeks of age, no differences in the weights of adrenal glands, pituitary glands and male and female reproductive organs were observed between treated and control animals. Results From the teratological part of the study, study, a NOAEL of 3 mg/kg bw/d was derived for dams (based on body weight reductions) and pups (based of ossified sternebrae and the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"No difference in the number of pups born and number of pups surviving until PND 4 was found between treated and control animals.","duration":"13 weeks","effect":"between PNDs 0 and 4. No difference in the number of pups born and number of pups surviving until PND 4 was found between treated and control animals. Also with respect to AGD, vaginal opening and preputial separation, there were no differences between treated and control animals. At 13 weeks of age, no differences in the weights of adrenal glands, pituitary glands and male and female reproductive organs were observed between treated and control animals. Results From the teratological part of the study, study, a NOAEL of 3 mg/kg bw/d was derived for dams (based on body weight reductions) and pups (based of ossified sternebrae and the","endpoint":"reproductive toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"3","page":25,"route":"","species":"","study_id":"sccs_o_053_noael_013"} |
| Regulatory source |
reproductive toxicity |
3 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=3; DOSE=No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2.; EFFECT=fter oral gavage administration to maternal animals during gestation. No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2. In a dominant-lethal test in NMRI mice (described in section 3.3.6.2 – Genotoxicity/Mutagenicity in vivo), fertility was clearly impaired at single i.p. dose levels of 79.8 and 86 mg/kg bw chloroacetamide. Based on body weight reduction in maternal animals and based on skeletal findings in the offspring, a NOAEL of 3 mg/kg bw/d was derived for dams and pups from a combined teratology/reproductive toxicity study, whose quality could not be ascertained. 3.3.9. Toxicokinetics Guideline: not stated Species/strain: Rat, Wistar Group size: 10 male animals per application pathway (5 animals for determination of blood levels, 5 animals for determination of excretion and tissue distribution, respectively) Test substance: [1-14C]-chloroacetamide Batch: 12o59 I (121 mCi/g) and 12o59 II (46.6 mCi/g) Radiochemical purity: > 98.0% Do; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2.","duration":"","effect":"fter oral gavage administration to maternal animals during gestation. No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2. In a dominant-lethal test in NMRI mice (described in section 3.3.6.2 – Genotoxicity/Mutagenicity in vivo), fertility was clearly impaired at single i.p. dose levels of 79.8 and 86 mg/kg bw chloroacetamide. Based on body weight reduction in maternal animals and based on skeletal findings in the offspring, a NOAEL of 3 mg/kg bw/d was derived for dams and pups from a combined teratology/reproductive toxicity study, whose quality could not be ascertained. 3.3.9. Toxicokinetics Guideline: not stated Species/strain: Rat, Wistar Group size: 10 male animals per application pathway (5 animals for determination of blood levels, 5 animals for determination of excretion and tissue distribution, respectively) Test substance: [1-14C]-chloroacetamide Batch: 12o59 I (121 mCi/g) and 12o59 II (46.6 mCi/g) Radiochemical purity: > 98.0% Do","endpoint":"reproductive toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"3","page":27,"route":"oral","species":"rat","study_id":"sccs_o_053_noael_015"} |
| Regulatory source |
reproductive toxicity |
3 |
mg/kg bw/d |
mouse |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=3; DOSE=No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2.; EFFECT=inant-lethal test in NMRI mice, fertility was clearly impaired by chloroacetamide. In a further study, the effects chloroacetamide on development and reproductive organs of the offspring were investigated after oral gavage administration to maternal animals during gestation. No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2. Based on body weight reduction in maternal animals and based on skeletal findings in the offspring, a NOAEL of 3 mg/kg bw/d was derived for dams and pups. Toxicokinetics Chloroacetamide is rapidly absorbed after oral and dermal administration. After administration of radiolabelled chloroacetamide, radioactivity is rapidly distributed. Two half-lives of elimination can be determined after oral, dermal and i.v. administration. Whereas the first elimination half-lives range between 5- 6 hrs for all application routes investigated, considerably longer second elimination half-lives of 500 hrs, 520 hrs and 180 hrs were calc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"79-07-2","citation":"","dose":"No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2.","duration":"","effect":"inant-lethal test in NMRI mice, fertility was clearly impaired by chloroacetamide. In a further study, the effects chloroacetamide on development and reproductive organs of the offspring were investigated after oral gavage administration to maternal animals during gestation. No adverse effects on reproductive tissues of the offspring were observed after repeated administration of 24 mg/kg bw/d from GD 14 to PND 2. Based on body weight reduction in maternal animals and based on skeletal findings in the offspring, a NOAEL of 3 mg/kg bw/d was derived for dams and pups. Toxicokinetics Chloroacetamide is rapidly absorbed after oral and dermal administration. After administration of radiolabelled chloroacetamide, radioactivity is rapidly distributed. Two half-lives of elimination can be determined after oral, dermal and i.v. administration. Whereas the first elimination half-lives range between 5- 6 hrs for all application routes investigated, considerably longer second elimination half-lives of 500 hrs, 520 hrs and 180 hrs were calc","endpoint":"reproductive toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"3","page":40,"route":"oral","species":"mouse","study_id":"sccs_o_053_noael_027"} |
| Regulatory source |
reproductive toxicity |
24 |
mg/kg bw/d |
- |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_053; REPORT_TITLE=OPINION ON Chloroacetamide COLIPA n° P27; OPINION_NUMBER=SCCS/1360/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=24; DOSE=Repeated administration of 24 mg/kg bw/d from GD 14 to PND 2 did not adversely affect the reproductive tissues of the offspring.; EFFECT=___________________ 26 number of ossified forelimb phalanges). Repeated administration of 24 mg/kg bw/d from GD 14 to PND 2 did not adversely affect the reproductive tissues of the offspring. Ref.: AR 73 Comment The study was available as translation from a Japanese original version. The quality of the translation could not be shown, however, some issues in the translated version raise some doubts on the study and/or translation (e.g. preputial separation is mentioned in the context of female animals). Thus, the NOAEL derived from this study is not taken into account for MOS calculation.; CITATION=Ref.: AR 73 Comment The study was available as translation from a Japanese original version; CITATION_NUMBERS=[73]; REFERENCE=Ref.: AR 73 Comment The study was available as translation from a Japanese original version; DETAILS_JSON={"cas_number":"79-07-2","citation":"Ref.: AR 73 Comment The study was available as translation from a Japanese original version","dose":"Repeated administration of 24 mg/kg bw/d from GD 14 to PND 2 did not adversely affect the reproductive tissues of the offspring.","duration":"","effect":"___________________ 26 number of ossified forelimb phalanges). Repeated administration of 24 mg/kg bw/d from GD 14 to PND 2 did not adversely affect the reproductive tissues of the offspring. Ref.: AR 73 Comment The study was available as translation from a Japanese original version. The quality of the translation could not be shown, however, some issues in the translated version raise some doubts on the study and/or translation (e.g. preputial separation is mentioned in the context of female animals). Thus, the NOAEL derived from this study is not taken into account for MOS calculation.","endpoint":"reproductive toxicity","ingredient":". The Committee agrees with provisional acceptance if","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"24","page":26,"route":"","species":"","study_id":"sccs_o_053_noael_014"} |