Saponification and oxidation product of carnauba wax with acidic sodium dichromate solution esterified with 1-methyl-1,3-propanediol and subsequent saponification with calcium dihydroxide

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 based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 25 MAR 1986 to 9 MAY 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 471). For justification of read-across within the category please see chapter 1 of the Chemical Safety Report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

in addition to the proposed strains, TA1538 was tested

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Montan waxes, Type E

IUPAC Name:

Montan waxes, Type E

Constituent 2

Reference substance name:

Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Montan wax

EC Number:

914-475-5

IUPAC Name:

Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Montan wax

Details on test material:

- Name of test material (as cited in study report): Hoechst Wachs E

Method

Target gene:

histidine revertants (Salmonella), tryptophan-dependent revertants (E. coli)

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 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S-9 fraction of Aroclor 1254-induced Sprague-Dawley rats

Test concentrations with justification for top dose:

first experiment: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
second experiment: 0, 4, 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

for TA 100 and TA 1535 without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

for TA 1537 without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

for TA 98 and TA 1538 without metabolic activation

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

for WP2 uvrA without metabolic activation

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

all strains with metabolic activation

Controls 6

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

all strains with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation)

DURATION
- Exposure duration: 48-72 h
- Expression time (cells in growth medium): 48-72 h

SELECTION AGENT (mutation assays): histidine for Salmonella strains, tryptophan for E. coli


DETERMINATION OF CYTOTOXICITY
- Method: determination of spontaneously occuring colonies, thinning of bacterial lawn

Evaluation criteria:

not stated

Statistics:

Results were analysed statistically, but the method was not stated

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:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

visible precipitation at 2500 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

visible precipitation at 2500 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

visible precipitation at 2500 µg/plate and above

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 without metabolic activation
negative with metabolic activation

The test substance was not mutagenic in these bacterial tests, both with and without metabolic activation.

Executive summary:

A bacterial mutagenicity test (according to guideline OECD 471) in Salmonella typhimurium strains TA100, TA 1535, TA 1537, TA 1538 and TA 98 as well as Ecscherichia coli strain WP2 uvrA was performed with Hoechst Wachs E in concentrations up to 10000 µg/plate in the first experiment and 5000 µg/plate in the second experiment with and without metabolic activation. The test substance was not mutagenic under these conditions. Appropriate positive controls showed a mutagenic response, thus confirming the validity of this study.