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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
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
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

Constituent 1
Chemical structure
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.