Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Very limited results were provided only for positive chemicals. Intent of study was to predict carcinogenicity/mutagenicity.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980

Materials and methods

Principles of method if other than guideline:
Male mice were dosed for five days. Five weeks later, the animals were sacrificed and sperm from the cauda epididymis were smeared onto slides. Slides were coded and sperm-head morphology was evaluated.
GLP compliance:
not specified
Type of method:
in vivo

Test material

Constituent 1
Details on test material:
- Purity: Not reported

Test animals

Species:
mouse
Strain:
other: (CBAxBALB/c)F1
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
5, 10, 20, 50, 100 mg/kg/day
Basis:

No. of animals per sex per dose:
5 males per dose
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOEL
Remarks:
sperm head morphology
Effect level:
100 mg/kg bw/day
Sex:
male
Basis for effect level:
other: The test substance did not induce changes in spermhead morphology.

Applicant's summary and conclusion

Conclusions:
The test substance did not induce changes in spermhead morphology.
Executive summary:

Groups of 5 male mice were dosed with the test substance or the negative or positive control substance for five days. Five weeks later, the animals were sacrificed and sperm from the cauda epididymis were smeared onto slides. Slides were coded and sperm-head morphology was evaluated. The test substance did not induce changes in spermhead morphology.

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