Registration Dossier
Registration Dossier
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EC number: 918-984-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral route (OECD 422), groups of 10 rats were exposed daily to 100, 300, 1000 mg/kg bw per day for 2 weeks before mating, during mating, gestation and until up to day 5 p.p. The NOAEL for the systemic toxicity was 1000 mg/kg bw per day in this study.
This study was performed with the registered substance diluted at 25%.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimich 1: the study was conducted according to OECD guideline 422, GLP study
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The inhalation route is not the most relevant one and a repeated dose toxicity study by oral route is available with no adverse effect observed
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Based on the available data sodium cocoyl apple amino acids will probably be absorbed to a low extent via the skin and via inhalation and to a significant extent via the gastro-intestinal-tract. Actually, classical surfactants are reported to reversibly damage and alter the physiological nature of the stratum corneum reducing then its diffusional resistance. Thus, in a weight of evidence dermal absorption rate of Sodium cocoyl apple amino acids is assumed to be to be low considering the adverse effect noted in skin irritation test. Furthermore, a repeated dose toxicity study by oral route is available
Justification for classification or non-classification
No evidence of chronic toxicity was observed. No classification required
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