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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Falling short of highest standards concerning aspects of protocol or reporting. Acceptable literature publication. Useful: supporting data.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Untersuchungen zur Stabilitat aromatischer Diisocyanat in Dimethylsulphoxid |(DMSO): Toluylendiisocyanat (TDI) und Diphenylmethandiisocyanat (MDI) im Ames-Test
Author:
Gahlmann R, Herbold B, Ruckes A & Seel K
Year:
1993
Bibliographic source:
Zbl.Arbeitsmed. 43: 34-38
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
Pre-dates, but is similar to, those of 84/449/EEC, B12, and OECD Test Guideline 474.
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
4,4'-diphenylmethane diisocyanate in dimethyl sulphoxide,
suspended in corn oil before use.

Test animals

Species:
mouse
Strain:
ICR
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
24 hour
Doses / concentrations
Remarks:
Doses / Concentrations:
0-200 mg MDI/kg
Basis:

Results and discussion

Test results
Sex:
not specified
Additional information on results:
An acute toxicity test gave a 7 day LD50 of about 100 mg/kg.
There were no deaths within 24 hr.
It was concluded that the test substance did not cause micronuclei, and therefore did not induce in vivo chromosomal aberration.
The number of erythrocytes with micronuclei differed little between treated groups and the solvent control.
The only statistically significant decrease in polychromatic erythrocytes occurred when the test substance was used at 200 mg/kg. This was taken to suggest inhibited myelopoietic function of the bone marrow.
When compared with distilled water, dimethyl sulphoxide in corn oil gave a statistically insignificant reduction in polychromatic erythrocytes, and increase in erythrocytes with micronuclei.

Applicant's summary and conclusion