Registration Dossier
Registration Dossier
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EC number: 413-390-6 | CAS number: 149144-85-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 170 mg/kg bw/day
Additional information
For the reproductive toxicity of bis(C12 -C13)alkyl-2 -hydroxybutandioate, no study could be located. Information on reproductive toxicity, available for di-2-ethylhexyl adipate as supporting substance, is use for read across.
Reproductive toxicity of di-2-ethylhexyl adipate was investigated in a One-generation reproduction toxicity study according to OECD TG 415 (Cefic, 1989). In a 28 day repeated dose toxicity study (OECD TG 407), reproductive organs of male and female animals were examined by necropsy and histopathology. In addition spermatogenesis and oestrous cycling was inspected (Miyata, 2006).
In the One-generation study, a reproductive NOAEL of 170 mg/kg bw/day was determined.
Di-2-ethyhexyl adipate is a saturated branched chain aliphatic adipate diester and structurally related to
bis(C12 -C13)alkyl-2 -hydroxybutandioate.
It is used as supporting substances for read across as justified in more detail in the endpoint summary of Section 7.1.1 - Basic toxicokinetics.The metabolite Malic acid did not cause reproductive toxicity in mice, rats or rabbits (International Journal of Toxciology, 2001).
Short description of key information:
Studies on fertility using bis(C12-C13)alkyl-2-hydroxybutandioate could not be located. Di-2-ethylhexyl adipate is used as supporting substance for read across.
In a One-generation reproduction toxicity study with di-2-ethylhexal adipate as test substance, a reproduction NOAEL of 170 mg/kg bw/day was determined for the P generation.
Justification for classification or non-classification
Additional information
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