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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
08.07.1987-09.11.1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance tetramethylthiuram disulfide (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance. (For detailed information on the justification of read-across, please refer to the analogue justification document attached in IUCLID section 13).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 84-2
Deviations:
no
GLP compliance:
yes
Remarks:
no attest of competent authority
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Thiram
- Analytical purity: 99.8 %
- Lot/batch No.: 921001
- Expiration date of the lot/batch: not provided
- Storage condition of test material: room temperature, protected from light

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
single dose
Frequency of treatment:
single dose
Post exposure period:
24, 48 and 72 h
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 38, 189 and 377 mg/kg body weight
Basis:
other: actually administered
No. of animals per sex per dose:
5
Control animals:
yes

Examinations

Tissues and cell types examined:
Bone marrow from femur was prepared.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The compound was tested up to a toxic dose level: 377 mg/kg bw was considered as the highest acceptable dose level. At this dose, mortality (15/38 animals), clinical signs and bone marrow toxicity (reduced ratio PCE/Total E) were observed. These effects were also apparent in some animals in the mid-dose group. No increase in the number of micronucleated polychromatic erythrocytes was detected at any of the sampling times. Experimental conditions as well as the criteria for the determination of test responses are well defined and appropriate. Positive controls gave the expected response.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative