Registration Dossier
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EC number: 212-344-0 | CAS number: 793-24-8
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:
- 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:
- 1 999
- 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:
- 1 999
- 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
- 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:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- 6PPD, 99 % purity
Constituent 1
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
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