Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Influence of 1,4-dichlorobutene on the generative function of experimental animals
Author:
Bal'yan VV, Petrosyan FR, Gizhlaryan MS (1983)
Year:
1983
Bibliographic source:
Biol. Zh. Arm. 36, 663-667.
Reference Type:
secondary source
Title:
1,4-Dichlorobut-2-ene- CAS No: 764-41-0
Author:
OECD SIDS
Bibliographic source:
SIDS Initial Assessment Report for 22th SIAM, UNEP Publications

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: no data
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,4-dichlorobut-2-ene
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
inhalation
Duration of treatment / exposure:
2.5 months
Doses / concentrations
Remarks:
Doses / Concentrations:
0.0018-0.0083 mg/L
Basis:

No. of animals per sex per dose:
No data
Control animals:
yes

Results and discussion

Test results
Sex:
male
Genotoxicity:
positive
Toxicity:
yes
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Inhalation of 0.0018-0.0083 mg/L 1,4-dichlorobut-2-ene for 2.5 months decreased DNA and RNA in rat spermatogenesis; 1st and 2nd order spermatocytes, spermatids, and spermatozoids. The test substance caused severe dystrophy, necrobiosis, and necrosis in the cells of spermatogenic epithelium. Endothelium of the associated blood vessels proliferated and the walls were swollen. Increased preimplantation mortality of embryos sired by the treated males with untreated females.

Applicant's summary and conclusion