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Toxicological information

Genetic toxicity: in vivo

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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No information about GLP.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Chemical mutagenesis testing in Drosophila. II. Results of 20 coded compounds tested for the National Toxicology Program
Author:
Zimmering S, Mason JM, Valencia R, Woodruff RC
Year:
1985
Bibliographic source:
Environm. Mutagen. 7, 87-100
Reference Type:
study report
Title:
Unnamed
Year:
1993
Reference Type:
other: OECD SIDS
Title:
1-Chloro-2-nitrobenzene, CAS: 88-73-3
Author:
OECD SIDS
Year:
2001
Bibliographic source:
SIDS Initial Assessment Report for SIAM 13

Materials and methods

Principles of method if other than guideline:
Treated (feeding for 72 hours) males were mated with 3 Basc virgin females for 3 days and were given fresh females at 2-day intervals to produce three matings of 3, 2 and 2 days. F1 heterozyrous females were mated with their siblings and then placed in individual vials. F1 daughters from the same parental male were kept together to identify clusters (a cluster occurs when a number of mutants from a given male result from a single spontaneous premeiotic mutation event, and is identified when the number of mutants from that male exceeds the number predicted by a Poissn distribution). Presumptive lethal mutations were identifed as vials containing fewer than 5% of the expected number of wild-type males after 17 days; these were retested to confirm the response.
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-chloronitrobenzene
- Physical state: pale yellow, flaky solid
- Purity: 99%
- Stability under test conditions: stable for 2 weeks as a bulk chemical when stored under a nitrogen headspace, protected from light, at temperatures up to 60 ºC
- Storage condition of test material: in amber glass containers under a nitrogen headspace at ca. 20 ºC

Test animals

Species:
Drosophila melanogaster
Strain:
other: Canton-S wild type
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 24 hours

Administration / exposure

Route of administration:
oral: feed
Vehicle:
10 % ethanol and 5 % sucrose solution
Details on exposure:
Toxicity tests were performed to set concentrations of 2-chloronitrobenzene at a level that would induce 30% mortality after 72 hours of feeding or 24 hours after injection, while keeping induced sterility at an acceptable level. Oral exposure was achieved by allowing Canton-S males to feed for 72 hours on a solution of 2-chloronitrobenzerle in 5% sucrose.
Duration of treatment / exposure:
72 hours
Frequency of treatment:
once
Doses / concentrations
Remarks:
Doses / Concentrations:
125 ppm
Basis:
nominal in diet
Control animals:
yes, concurrent vehicle

Examinations

Evaluation criteria:
A test result was considered positive if the P-value was less than or equal to 0.01 and ihe mutation frequency in the tested group was greater than 0.10% or if the P-value was less than or equal to 0.05 and the frequency in the treatment group was greater than 0.15%. A test was considered to be inconclusive if the P-value was between 0.05 and 0.01 but the frequency in the treatment group was between 0.10% and 0.15% or if the P-value was between 0.10 and 0.05 but the frequency in the treatment group was greater than 0. 10%. A test was considered negative if the P-value was greater
than or equal to 0.10 or if the frequency in the treatment group was less Ihan 0.10%.
Statistics:
Sex-linked recessive lethal data were analyzed by simultaneous comparison with the concurrent and historical controls using a normal approximation to the binomial test.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not applicable
Positive controls valid:
not specified

Applicant's summary and conclusion