Registration Dossier
Registration Dossier
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EC number: 203-629-0 | CAS number: 108-91-8
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: tables and abstract only
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Cyclohexylamine, a chomosome aberration inducing substance: no teratogenicity in mice
- Author:
- Takano K, Suzuki M
- Year:
- 1 971
- Bibliographic source:
- Senen IjoCongenital anomalies 11, 51-57
- Reference Type:
- review article or handbook
- Title:
- No 283. Cyclohexylamine in
- Author:
- Shepard ThH
- Year:
- 1 986
- Bibliographic source:
- Catalog of teratogenic agents, The John Hopkins University Press, Baltimore and London, pp88-89
Materials and methods
- Principles of method if other than guideline:
- Application of different doses to pregnant female mice from day 6 to day 11 of gestation; day 18: removal of fetuses
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohexylamine
- EC Number:
- 203-629-0
- EC Name:
- Cyclohexylamine
- Cas Number:
- 108-91-8
- Molecular formula:
- C6H13N
- IUPAC Name:
- cyclohexanamine
- Details on test material:
- no further data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Details on test animals or test system and environmental conditions:
- Room temperature: 21-24 °C
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Application of different doses to pregnant female mice by gavage from day 6 to day 11 of gestation; day 18: removal of fetuses
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- no data: pregnant mice were used
- Duration of treatment / exposure:
- day 6 to day 11 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- until day 18 of gestation
- No. of animals per sex per dose:
- i00 mg/kg bw: 17 mothers
50 mg(kg bw: 10 mothers
20 mg7kg bw11 mothers
control: 7 mothers - Control animals:
- yes
- Details on study design:
- Application of different doses to pregnant female mice from day 6 to day 11 of gestation; day 18: removal of fetuses
Examinations
- Maternal examinations:
- mortality
- Ovaries and uterine content:
- all implantation sites
- Fetal examinations:
- body weights external malformations and skeletal abnormalities
- Statistics:
- yes, but method not given
- Indices:
- no
- Historical control data:
- no
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
at 100 mg/kg bw/day mild lethality (no further data)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day
- Based on:
- not specified
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- dose level:
- Effect level:
- >= 20 - <= 100 mg/kg bw/day
- Based on:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: no other teratogenic effects than observed in controls were reported
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
at body weight of living fetuses was significantly decreased, but no tetatogenic effects were reported
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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.
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