Registration Dossier
Registration Dossier
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EC number: 825-403-6 | CAS number: 2060541-51-5
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- There is no repeat dose dermal study on Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5), but two valid read across studies from two 28 day oral toxicity studies according to OECD 422 are available. Based on the physicochemical properties of the substance, it is considered very unlikely that dermal absorption would exceed oral absorption, so it would be expected that the oral NOAEL would be lower than a corresponding value from a dermal study. Data from the repeat dose oral study can be used in the setting of DNELs in accordance with the REACH guidelines. As appropriate DNEL values can be calculated using the oral dosing study data, it is not justified on animal welfare grounds to perform a repeat dose dermal toxicity study.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- As appropriate DNEL values can be calculated using the oral dosing study data, it is not justified on animal welfare grounds to perform a repeat dose dermal toxicity study.
- Executive summary:
There is no repeat dose dermal study on Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5), but two valid read across studies from two 28 day oral toxicity studies according to OECD 422 are available. Based on the physicochemical properties of the substance, it is considered very unlikely that dermal absorption would exceed oral absorption, so it would be expected that the oral NOAEL would be lower than a corresponding value from a dermal study. Data from the repeat dose oral study can be used in the setting of DNELs in accordance with the REACH guidelines. As appropriate DNEL values can be calculated using the oral dosing study data, it is not justified on animal welfare grounds to perform a repeat dose dermal toxicity study.
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