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Toxicological information

Toxicity to reproduction: other studies

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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:
1981
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

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:
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

Rats:
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