4-methyl-salicylamide

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across from structurally similar compound. More information on read-across can be found in endpoint summary 7.6.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of analgesics, their derivatives, and anti-inflammatory drugs with S-9 mix of several animal species

Author:

Kuboyama N & Fujii A

Year:

1992

Bibliographic source:

J. Nihon Univ. Sch. Dent., 1992, 34, 183-195

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Only strains TA98 and TA100; maximum dose 100 microgram/plate

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Substance type: pure active substance
- Physical state: solid
- Supplier: Wako Pure Chemical Industries
- Analytical purity: no data

Method

Target gene:

his D3052, G46

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 liver mix from male rats (SD strain), male mice (ddy strain), male guinea pigs (Hartley strain) and male golden hamsters; all induced with 500 mg/kg polychlorobiphenyl i.p.

Test concentrations with justification for top dose:

0.1 mg / plate

Vehicle / solvent:

DMSO 0.1 ml / plate

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

Migrated to IUCLID6: AF-2 (furyl furamide, 2-(furan-2-yl)-3-(5-nitrofuran-2-yl)prop-2-enamide), benzopyrene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 30 min at 37°
- Exposure duration: 48 h at 37°
NUMBER OF REPLICATIONS: 5
NUMBER OF CELLS EVALUATED: no data

Evaluation criteria:

number of his+ revertants more than twice the number of spontaneous revertants considered to be mutagenic

Statistics:

mean and standard deviation for 5 plates

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

Most revertant numbers below those of DMSO control

Cytotoxicity / choice of top concentrations:

not specified

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:

with and without

Genotoxicity:

negative

Remarks:

Maximum ratio of revertant numbers (treated / DMSO control) = 1.27

Cytotoxicity / choice of top concentrations:

not specified

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

Conclusions:

Interpretation of results (migrated information):
negative

The test substance is considered not mutagenic in vitro. The study is considered to be reliable with some restrictions and suitable for use as part of the read-across assessment.