2,4-dichloroaniline

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:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with restrictions

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity tests: V. Results from the testing of 311 chemicals

Author:

Zeiger E, Anderson B, Haworth S, Lawlor T, and Mortemals K

Year:

1992

Bibliographic source:

Environmental and Molecular Mutagenesis. Volume 19, Supplement 21:2-141

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No GLP study. No E.coli strain tested. Only 4 strains tested

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dichloroaniline

EC Number:

209-057-8

EC Name:

2,4-dichloroaniline

Cas Number:

554-00-7

Molecular formula:

C6H5Cl2N

IUPAC Name:

2,4-dichloroaniline

Test material form:

not specified

Details on test material:

- Name of test material (as cited in publication): 2,4-dichloroaniline
- Analytical purity: >99%

Method

Target gene:

his

Species / strain

Species / strain / cell type:

other: S.thyphimurium TA100, TA1535, TA1537, TA97, TA98

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

microsomal enzyme reaction mix (S9-mix) from hamster and rat liver induced with Aroclor 1254. RLI (Aroclor 1254-induced rat liver S-9); HLI (Aroclor 1254-induced hamster liver S9)

Test concentrations with justification for top dose:

0, 3.3, 10.0, 33.0, 100.0, 200.0, 333.0, 500.0, 666.0 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

mitomycin C

other: 4-nitro-o-phenylene diamine, methylmethane sulphonate, 2-aminoanthracene

Details on test system and experimental conditions:

pre-incubation protocoll: at least 5 concentrations of each chemical were tested in triplicate

Evaluation criteria:

Individual trials were judged

Results and discussion

Test results

Test results 1

Species / strain:

other: S.thyphimurium TA1535, TA1537, TA97, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at doses higher then 333.0

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

negative

Remarks:

with S9 (5% HLI; 10% HLI, first and second trial)

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

positive

Remarks:

with S9 (30% HLI first and fourth trial)

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

from 666 µg/PLATE

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

ambiguous

Remarks:

with S9 (30% HLI second and third trial)

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

from 333 µg/PLATE for the second trial

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 6

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

negative

Remarks:

with S9 (10% RLI and 30% RLI second trial )

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

from 333 µg/PLATE

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 7

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

ambiguous

Remarks:

with S9 (30% RLI first trial )

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

from 333 µg/PLATE

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

2,4 -Dichloroaniline was tested for induction of point mutations in bacteria up to 666 µg/plate using the Ames test and Salmonella typhimurium strains TA97, TA98, TA100, TA1535, TA1537 in the absence and in the presence of metabolic activation systems derived from rat and hamster livers.

2,4 -Dichloroaniline did not induce increased numbers of revertants in Salmonella typhimurium TA 1537, TA 1535, TA97 and TA 98 neither in the presence nor in the absence of a metabolic activation system. In Samonella typhimurium TA100 in the presence of 30% hamster liver S9 -mix or 30 % rat liver S9 -mix questionable or weak positive results were obtained but not in the presence of 10 % hamster liver or 10 % rat liver S9 -mix and in absence of metabolic activation systems.

Thus, based on the results obtained, 2,4 -dichloroaniline is evaluated as weak mutagen in the Ames test under the applied conditions .