2-chloroaniline

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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: Comparable to guideline study with acceptable restrictions; 5th test strain missing

Data source

Reference

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: III. Results from the testings of 255 chemicals

Author:

Zeiger, E et al.

Year:

1987

Bibliographic source:

Environmental Mutagenesis 9 (suppl.9): 1-110

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

; no strain with AT base pair as primary mutation site tested

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

; no strain with AT base pair as primary mutation site tested

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroaniline

EC Number:

202-426-4

EC Name:

2-chloroaniline

Cas Number:

95-51-2

Molecular formula:

C6H6ClN

IUPAC Name:

2-chloroaniline

Details on test material:

- Name of test material (as cited in study report): o-chloroaniline

- Analytical purity: >98 %

- Other: purchased from Aldrich

Method

Target gene:

histidine operon

Species / strain

Species / strain / cell type:

other: S. typhimurium TA100, TA1535, TA97 and TA98

Metabolic activation:

with and without

Metabolic activation system:

10 or 30 % of male Syrian hamster or male Sprague Dawley rat liver S9-mix

Test concentrations with justification for top dose:

3.3, 10, 33, 100, 333, 1000 and 3333 µg/plate, tested in triplicates

Vehicle / solvent:

- Vehicle/solvent used: DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other:

Remarks:

sodium azide ( TA1535, TA100), 9-aminoacridine (TA97), 4-nitro-o-phenylenediamine (TA98), 2-aminoanthracene (control for metabolic activation in all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation


DURATION
- Preincubation period: 20 min 37 °C
- Exposure duration: 48 h, 37 °C



NUMBER OF REPLICATIONS: triplicates

his+ revertants counted


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

data were evaluated as described by Haworth et al. (1983).
A positive response in the S. typhimurium assay is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. an equivocal response is defined as an increase in revertants that was not dose related, not reproducible, or not of sufficient magnitude to support a determination of mutagenicity. A negative response was obtained when no increase in revertant colonies was observed following chemical treatment. There was no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA100, TA1535, TA97 and TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

3333 µg/plate with metabolic activation in all strains

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: other: S. typhimurium TA100, TA1535, TA97 and TA98

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Zeiger, E et al. (1987)

O-chloroaniline ( 3.3, 10, 33, 100, 333, 1000 and 3333 µg/plate) was tested for genotoxicity in a bacterial reverse mutation assay with Salmonella typhimurium TA97, TA98, TA100 and TA 1535 with and without metabolic activation with either aroclor 1254 induced male Syrian hamster liver S9-mix or male Sprague Dawley rat liver S9-mix (10 and 30 %). The obtained results were negative in all strains tested, whereas the positive and negative controls acted as expected and were therefore valid.