Registration Dossier
Registration Dossier
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EC number: 233-221-8 | CAS number: 10094-34-5
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- α,α-dimethylphenethyl acetate
- EC Number:
- 205-781-3
- EC Name:
- α,α-dimethylphenethyl acetate
- Cas Number:
- 151-05-3
- Molecular formula:
- C12H16O2
- IUPAC Name:
- 1,1-dimethyl-2-phenylethyl acetate
- Test material form:
- solid
Constituent 1
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean body weight of rats from high dose group (1000 mg/kg) was slightly lower than that of from vehicle control group throughout the premating period (for both males and females) and mating period (for males).
The values of mean body weights and mean body weight gain for rats treated with test item at and up to 1000 mg/kg did not differ significantly (p>0.05) from those of the concurrent control group rats during the gestation period and the post-natal lactation period. - Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- There was no treatment related adverse effect on pregnancy rate, gestational length, live births and implantations.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- The incidence of litters with still-born pups, pups found dead in cage or cannibalised pups were very small and / or comparable across the treated and the control groups.
- Body weight and weight changes:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Sex:
- not specified
- Basis for effect level:
- clinical signs
- mortality
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- no
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
