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Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study was not carried out following a guideline method nor under a quality assurance system. The method description lacks of detailed documentation and the raw data were not presented.

Data source

Reference
Reference Type:
publication
Title:
Genotoxicity of aniline derivatives in various short-term tests
Author:
Kugler-Steigmeier ME, Friederich U, Graf U, Lutz WK, Maier P, Schlatter C
Year:
1989
Bibliographic source:
Mutation Research, 1989, vol. 211, p. 279 - 289

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Somatic mutation and recombination test in Drosophila melanogaster: Larvae (72 h) transheterozygous for the mutations multiple wing hair (mwh, 3-0.0) and flare (flr, 3-38.8) were fed the test substance for 48 h. Spontaneous mutation frequency was determined from solvent controls. Induced spots on the wings were scored and subject to statistical analysis.
GLP compliance:
no
Type of assay:
somatic mutation and recombination test in Drosophila

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4,6-trichloroaniline
EC Number:
211-219-8
EC Name:
2,4,6-trichloroaniline
Cas Number:
634-93-5
Molecular formula:
C6H4Cl3N
IUPAC Name:
2,4,6-trichloroaniline
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 2,4,6-TCA.
- Source: EGA Chemic, Stammheim (F.R.G.).
- Analytical purity: > 99 %, checked by gas chromatography.

Test animals

Species:
Drosophila melanogaster
Strain:
other: trans-heterozygous for the mutations multiple wing hair (mwh, 3-0.0) and flare (flr, 3-38.8)
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 72 h old larvae.
- Diet (e.g. ad libitum): Drosophila Instant Medium (Formula 4- 24, Carolina Biological Supply Company, Burlington, NC, U.S.A.)

Administration / exposure

Route of administration:
oral: feed
Vehicle:
- Vehicle(s)/solvent(s) used: aqueous solution containing 3 % absolute ethanol and 1 % Tween 80.
- Justification for choice of solvent/vehicle: used to prepare Drosophila Instant Medium.
Duration of treatment / exposure:
48 hours.
Doses / concentrations
Remarks:
Doses / Concentrations:
5 mM
Basis:
nominal in diet
spiked drosophila instant medium
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
The larvae were treated, and the wings prepared and scored for induced spots according to Graf et al. (1984).
Statistics:
Statistical analysis of the data was carried out as described by Frei and Würgler (1988).

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
positive
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
The test item tended to induce mainly small spots, which suggests that the somatic mutations were induced late in the development
of the larvae, at a time point where only 1-2 more cell divisions took place. This phenomenon can be explained by the increasing activity of
the metabolizing enzymes in the course of the development of the larvae (Hallstrrm et al., 1983).

Any other information on results incl. tables

Table 1: Results

Number of wings Spots per wing and statistical diagnoses
Small single spot m=2.0 Large single spots m=5.0 Twin spots m=5.0 Total spots m=2.0
80 0.45 + 0.08 - 0.01 i 0.54 +

+ positive, - negative, w weak, i inconclusive. Probabifity levels α = ß = 0.05. One-sided statistical tests. Small single spots 1-2 cells, large single spots > 2 cells, m multiplication factor.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
From the absence of induced twin spots it can be concluded that, under the conditions of the somatic mutation assay in Drosophila the compounds did not exhibit strong recombinogenic activity and the somatic mutations were induced late in the development of the larvae.

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