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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study; original reference in Japanese, compilation of data from English summary and tables

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1999
Reference Type:
publication
Title:
Reverse mutation test of N-(1,3- dimethylbutyl)-N'-phenyl-p-phenylenediamine on bacteria.
Author:
Shibuya T, Hara T, Kawakami K
Year:
1999
Bibliographic source:
Tox Testing Rep Environ Chemicals 7: 530-536

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
EC Number:
212-344-0
EC Name:
N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
Cas Number:
793-24-8
Molecular formula:
C18H24N2
IUPAC Name:
N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine
Details on test material:
6PPD, 99 % purity

Method

Target gene:
ames assay
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
µg/plate: TA1535, TA1537/-S9mix: up to 19.5; TA98, 100/-S9mix: up to 78.1; TA100, TA1535, TA1537/+S9mix: up to 156; TA98/+S9mix: up to 625 (details see TC)
E. coli: 313, 625, 1250, 2500, 5000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9: AF2, sodium azide, 9-aminoacridine, +S9:2-aminoanthracene
Details on test system and experimental conditions:
IUCLID4 Type: Ames test

Results and discussion

Test resultsopen allclose all
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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: > 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Toxicity: µg/plate: TA1535, TA1537/-S9mix: 9.77-19.5; TA98, 100/-S9mix: 39.1; TA100, TA1535/+S9mix: 156; TA1537/+S9mix: 78.1; TA98/+S9mix: 625

The test substance did not induce gene mutation in S. typhimurium tester strains with and without metabolic activation.

The positive control chemicals (sodium azide, 2-aminoanthracene,  9-aminoacridine, 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide) 

led to the expected increase in revertants.

Toxicity was not observed in E. coli WP2 uvrA with or without metabolic activation. This chemical did not indice gene mutations in E. coli strain WP2 uvrA.

Precipitate was observed on the surface of agar plates over the whole tested concentration range in the absence of S9 mix only.

The positive control chemicals (2-aminoanthracene and   2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide) led to the expected 

increase  in revertants.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative