Registration Dossier
Registration Dossier
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EC number: 203-629-0 | CAS number: 108-91-8
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only one dose used
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Testicular respnses of rats and dogs to cyclohexylamine overdosage
- Author:
- James RW, Heywood R, Crook D
- Year:
- 1 981
- Bibliographic source:
- Food Cosmet. Toxicol. 19, 291-296
Materials and methods
- Principles of method if other than guideline:
- Application of
200 mg/kg bw/day to 15 male rats by gavage for 9 weeks (15 served as controls)
250 mg/kg bw/day to 4 male dogs by gavage
to examine the effects of massive doses on pituitary-testicular hormones, semen characteristics and quantitiave assessment of spermatogenesis. Subsequently some of these animals were maintained undosed for 13 weeks to assess recovery - GLP compliance:
- not specified
- Type of method:
- in vivo
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:
- other: rat, dog
- Strain:
- other: CD rat, Beagle dog
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 9 weeks
- Frequency of treatment:
- daily
- Duration of test:
- 9 weeks and 13 weeks recovery
Doses / concentrations
- Remarks:
- Doses / Concentrations:
rat: 200 mg/kg bw/day; dog: 250 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 15 treated rats (5 rats for recovery) and 15 controls
4 dogs and 2 of them for recovery - Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- other: rat dose level
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Sex:
- male
- Dose descriptor:
- other: dog dose level
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Sex:
- male
Observed effects
decreased body weight gain and food intake;
motor activity decreased
testicular and seminal vesicles weights were lowered
increased FSH and decreased testosterone concentrations in sera;
decreased spermatogenesis (pachytene spermatocytes, early and late spermatids);
1/15 rats showed bilateral testicular atrophy
dogs:
vomiting, loose feces, motor activity decreased,
the loss of body weight during treatment was completely reversed during the recovery period;
food intake decreased
pachytene spermatocyes , early and late spermatids decreased
the effects on sperm morphology and the reduction of spermatogenesis were also reversible
Applicant's summary and conclusion
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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.
