Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
embryonic mortality, mutagens
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: unsuitable test system, incomplete and inexact data on study design.

Data source

Reference
Reference Type:
publication
Title:
Effect of Vulcanization accelerators on embryonic mortality in rats
Author:
Aleksandrov, S.E.:
Year:
1982
Bibliographic source:
Bull. Exp. Biol. Med. 93, 87-88

Materials and methods

Principles of method if other than guideline:
Rats were applied Santocure (N-cyclohexylbenzothiazole-2-sulphenamide) before or during pregnancy to determine the primary mechanism of embryonic mortality (mutagenic action on gametes at the beginning of embryogenesis, toxic action of the chemical on the embryo or hormonal disturbances in the mother).
GLP compliance:
no
Type of assay:
other: embryonic mortality

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Santocure CBS

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
Females: twice (1st, 3rd day of oestrus), males (interval of 3 days)
Doses / concentrations
Remarks:
Doses / Concentrations:
2000 mg/kg bw
Basis:

No. of animals per sex per dose:
10 females treatment group, control: 25 females

Results and discussion

Test results
Sex:
male/female

Any other information on results incl. tables

No increased postimplantation embryonic mortality (= "index of mutagenicity").

Applicant's summary and conclusion

Executive summary:

Rats were applied Santocure (N-cyclohexylbenzothiazole-2-sulphenamide) before or during pregnancy to determine the primary mechanism of embryonic mortality (mutagenic action on gametes at the beginning of embryogenesis, toxic action of the chemical on the embryo or hormonal disturbances in the mother). On the basis of these experimental results it was not possible to determine precisely which mechanism caused the rise in embryonic mortality and the decrease in weight of the fetuses.