Registration Dossier
Registration Dossier
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EC number: 400-410-3 | CAS number: 25485-88-5
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 400-410-3
- EC Name:
- -
- Cas Number:
- 25485-88-5
- Molecular formula:
- C13H16O3
- IUPAC Name:
- cyclohexyl 2-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- Females mated at the supplier with an accurate day of mating.
- Duration of treatment / exposure:
- Orally by gavage once daily from day 6 to day 15 post coitum.
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 120 and 360 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Groups 1, 2 and 3 - 23 pregant rats. Group 4 - 22 preganant rats.
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 360 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No symptoms of toxicity nor embryotoxic or teratogenic potential up to a dose level of 360 mg/kg bw/day.
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.
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