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Toxicological information

Developmental toxicity / teratogenicity

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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:
1971
Bibliographic source:
Senen IjoCongenital anomalies 11, 51-57
Reference Type:
review article or handbook
Title:
No 283. Cyclohexylamine in
Author:
Shepard ThH
Year:
1986
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

Constituent 1
Chemical structure
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

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