3-amino-4-chlorobenzoic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read across substance, limited data on test material

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

maximum concentration 10.000 microgramm/plate

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

para-aminobenzoic acid

IUPAC Name:

para-aminobenzoic acid

Constituent 2

Reference substance name:

4-aminobenzoic acid

EC Number:

205-753-0

EC Name:

4-aminobenzoic acid

Cas Number:

150-13-0

IUPAC Name:

4-aminobenzoic acid

Method

Target gene:

his

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 97

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9-mix, non-induced hamster S9-mix

Test concentrations with justification for top dose:

0 (control), 100, 333, 1000, 3333, 10000 μg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

potassium chloride

Positive controls:

yes

Positive control substance:

other: sodium azide for TA1535 and TA 100, 4-nitro-o-phenylenediamine for TA98, and 9-aminoacridine for TA97 and TA1537

Remarks:

without metabolic activation

Controls 2

Positive control substance:

other: 2-aminoanthracene was used with all strains

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20min

Evaluation criteria:

1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold ; 2) nonmutagenic response: when no increase in the number of revertants was elicited by the chemical ; 3) questionable response : when there was an absence of a clear-cut dose-related increase in revertants ; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity .

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
All chemicals were initially tested with strain TA100 in the presence and the absence of the metabolic activation systems, over a wide dose range with an upper limit of 10 mg/plate or less when solubility problems were encountered . Toxicity was evidenced by one or more of the following phenomena: appearance of his- pinpoint colonies, reduced numbers of revertant colonies per plate, or thinning orabsence of the bacterial lawn

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative