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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study based on scientific principles, comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Mutagenic activity of 41 compounds in the in vivo micronucleus assay
Author:
Salamone MF, Heddle JA, Katz M
Year:
1981
Bibliographic source:
Evaluation of short-term tests for carcinogens, Progress in Mutation Research, Vol. 1 (de Serres FJ, Ashby J), Elsevier North-Holland, New York, Amsterdam, Oxford (1981)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Anthracene supplied by ICI

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Biobreeders Laboratory Ottawa, Ontario
- Age at study initiation: no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: DMSO
Duration of treatment / exposure:
first test: 48, 72 and 96 h
second test: 30, 48, and 60 h
Frequency of treatment:
first test: 2x, 24 h apart
second test 1x each (2 doses)
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
ca. 350 mg/kg (as 2 applications per animal)
Basis:
other: 80 % of the LD50 (within 7 d)
Remarks:
Doses / Concentrations:
ca. 350 mg/kg (1 applications per animal)
Basis:
other: 80 % of the LD50 (within 7 d)
Remarks:
Doses / Concentrations:
ca. 175 mg/kg (1 applications per animal)
Basis:
other: 40 % of the LD50 (within 7 d)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
various known carcinogens, e.g. 2-acetylaminofluorene; benzo(a)pyrene; cyclophosphamide; urethane

Examinations

Tissues and cell types examined:
red blood cells (PCE)
Evaluation criteria:
A positive result is weighed in relation to an average background rate of 0.642 micronuclei per mouse, with 500 PCE (polychromatic erythrocytes) scored per mouse, accepting arate of false positives of 10 % (see Report, Tab. 1).
Statistics:
see "Evaluation criteria"

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
yes
Remarks:
dose 40 - 80 % of LD50
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative