1-chloro-2-nitrobenzene

Genetic toxicity: in vivo

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

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1985

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1993

Reference 3

Reference Type:

other: OECD SIDS

Title:

Unnamed

Year:

2001

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 or test system 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 validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not specified