mixture of two components: 1. N-(1,3- dimethylbutyl)-N´- phenyl-p-phenylenediamine 2. N1-(1,3-dimethylbutyl)- N4-(4-(1-methyl-1- phenylethyl)phenyl)ben zene-1,4-diamine

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

Study period:

7.2. 2000 - 30.3.2000

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: B.14 Mutagenicity, test of reversal mutagenicity, Salmonella typhimurium OECD NO. 471

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Test batch: No.. 7/99

Method

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium : (TA1537, TA98, TA100 , TA1535)

Metabolic activation:

with and without

Metabolic activation system:

The simulation of the absorption metabolism was carried out by S9 fraction of the liver homogenate and the co-factors mixture.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): .01 ... .5 µg/plate
Concentration range in the main test (without metabolic activation): .01 ... .5 µg/plate

Vehicle / solvent:

Solvent: dimethylsulphoxid

Results and discussion

Test results

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:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
According to the mentioned results Dusantox L is not

mutagenic, by test with metabolic as without metabolic
activation.

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 with metabolic activation
negative without metabolic activation

The test results : whithout the bacterial backround changes - all concentration are not toxic.