Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
other:
Justification for type of information:
There is no repeat dose dermal study on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1), but a 28 day oral toxicity study according to OECD 422 is 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 oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1), but a 28 day oral toxicity study according to OECD 422 is 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.