Hydrogenated rosin, zinc salt

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

bis((7-isopropyl-1,4a-dimethyl-1,2,3,4.4a.5.6.7.8.9.10.10a-dodecahydrophenanthrene-1-carbonyl)oxy)zinc

EC Number:

810-810-3

Cas Number:

68425-02-5

Molecular formula:

The substance is a UVCB, of which a major component can be represented by the following: [C20H33O2]2Zn

IUPAC Name:

bis((7-isopropyl-1,4a-dimethyl-1,2,3,4.4a.5.6.7.8.9.10.10a-dodecahydrophenanthrene-1-carbonyl)oxy)zinc

Test material form:

solid

Details on test material:

- Appearance: Brown coloured, brittle solid
- Storage condition of test material: At room temperature
- Chemical name: Zinc modified rosinate, hydrogenated zinc rosinate
- CAS No.: 68425-02-5

Method

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:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9-mix (rat liver S9-mix induced by Aroclor 1254)

Test concentrations with justification for top dose:

In the dose range finding test, the test item was tested up to concentrations of 5000 μg/plate in the
absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test item precipitated on the plates at dose levels of 1600 μg/plate and 5000 μg/plate. The test item precipitated on the plates at the top dose of 800 μg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. Results of this dose range finding test were reported as part of the first mutation assay.

Based on the results of the dose range finding test, the test item was tested in the first mutation assay at a concentration range of 9 to 800 μg/plate in the absence and presence of 5% (v/v) S9-mix in the tester strains TA1535, TA1537 and TA98. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.

In a follow-up experiment of the assay with additional parameters, the test item was tested at a
concentration range of 17 to 1600 μg/plate in the absence and presence of 10% (v/v) S9-mix in the
tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. The test item precipitated on the plates at the top dose of 1600 μg/plate. The bacterial background lawn was not reduced at any of the
concentrations tested and no biologically relevant decrease in the number of revertants was observed.

Vehicle / solvent:

Tetrahydrofuran

Controls

Controls 1

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

sodium azide

methylmethanesulfonate

other:

Controls 2

Positive controls:

yes

Positive control substance:

other:

Remarks:

With metabolic activation:
Strain - Conc./plate - Amount of S9-mix
TA1535 - 2.5 μg - 5 and 10%
TA1537 - 2.5 μg - 5%
TA1537 - 5 μg -10%
TA98 -1 μg - 5 and 10%
TA100 - 1 μg - 5%
TA100 - 2 μg - 10%
WP2uvrA - 15 μg - 5 and 10%

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 2

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 5

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Applicant's summary and conclusion

Conclusions:

Resin acids and Rosin acids, hydrogenated, zinc salts did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment.

The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.

Executive summary:

Based on the results of this study it is concluded that the test item Resin acids and Rosin acids, hydrogenated, zinc salts is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.