Registration Dossier

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test guideline (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.34 (One-Generation Reproduction Toxicity Test)
Principles of method if other than guideline:
Study preceding OECD and EU guideline, but experimental design is in accordance with these guidelines.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: gas

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure (if applicable):
whole body
Details on exposure:
6hrs/day 5 d/week
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Mean daily analytical levels (averaged for all exposure days) were within 5% of the target levels(10, 30 and 60 ppm): 10.0, 28.5 and 57.2 ppm
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10.0 ppm
Basis:
analytical conc.
Remarks:
Doses / Concentrations:
28.5 ppm
Basis:
analytical conc.
Remarks:
Doses / Concentrations:
57.2 ppm
Basis:
analytical conc.
No. of animals per sex per dose:
15
Control animals:
yes, concurrent no treatment

Examinations

Parental animals: Observations and examinations:
No male fertility effects were oeserved in any of the exposure level groups. Treated males were comparaele to control group males in effecting pregnancy. Females mated to exposed males were comparable to females mated to control males in numbers or live implants and pre- and post implantation loss. Therefore, this study indicates that acetone cyanohydrin does not produce male fertility effects in rats at inhalation exposure levels at least as high as 60 ppm.

Results and discussion

Results: P0 (first parental animals)

General toxicity (P0)

Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed

Reproductive function / performance (P0)

Reproductive performance:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEC
Effect level:
60 ppm
Sex:
male

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Tested substance does not affect male fertility in rats in doses up to 60 ppm.
Executive summary:

Male Sprague-Dawley rats, in groups of fifteen, were exposed by the inhalation route (6 hrs/day, 5 days/week) to acetone cyanohydrin at target levels of 10, 30 and 60 ppm. Mean daily analytical levels (averaged for all exposure days) were witnin 5% of the target levels: 10.0, 28.5 and 57.2 ppm. Males were exposed for 48 exposure days (69 days on study) and mated to untreated females. Exposure of the males was continued through the day after the last mating opportunity (58 exposure days). No toxic effects were observed in males of any of the exposure groups. Mean body weights of treated male groups were not significantly different from control group body weights and no treatment-related clinical signs of toxicity were observed before, during or after exposure. There were no remarkable lesions detected in any of the exposed males at necropsy. No male fertility effects were observed in any of the exposure level groups. Treated males were comparable to control group males in effecting pregnancy. Females mated to exposed males were comparable to females mated to control males in numbers of live implants and pre- and post implantation loss. Therefore, this study indicates that acetone cyanohydrin does not produce male fertility effects in rats at inhalation exposure levels at least as high as 60 ppm.