Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study to then current Guideline and subject to GLP audit.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, maleated

EC Number:

232-480-4

EC Name:

Rosin, maleated

Cas Number:

8050-28-0

Molecular formula:

Not applicable as the substance is a UVCB

IUPAC Name:

Rosin, maleated

Details on test material:

- Name of test material (as cited in study report): rosin maleated
- Substance type: chemically modified UVCB
- Physical state: solid
- Analytical purity:100%
- Purity test date:Certificate of analysis dated 15 April 1991
- Lot/batch No.: 05991041.9
- Stability under test conditions:assumed stable
- Storage condition of test material: room temperature in original container
- Other: Trade name Dynakoll VS 50M; 15.5% maleated

Method

Target gene:

His

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9

Test concentrations with justification for top dose:

50, 158, 500, 1580, 5000 mcg

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:substance soluble in it

Details on test system and experimental conditions:

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

DURATION
- Exposure duration: 2 days

NUMBER OF REPLICATIONS:two independant assays, triplicate plates

Evaluation criteria:

Increase in number of revertants

Statistics:

Mean and standard deviation

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 nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Negative with and without metabolic activation

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Positive controls (sodium azide, 2 -aminoanthracene, 9 -aminoacridine, 2 -nitrofluorene, benzo(a)pyrene

gave the expected response

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Based on an absence of genotoxic/mutagenic effects in a bacterial reverse mutation test with Salmonella typhimurium strains TA 98, TA 100, TA 1535 or TA 1537, with or without metabolic activation, rosin, maleated is not classifiable for Germ Cell Mutagenicity according to Directive 67/548/EEC, the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA1535, TA1537, TA98, and TA100 of S. typhimurium were exposed to rosin, maleated (CAS 8050-20-28) in ethanol at concentrations of 50, 158, 500, 1580, 5000 mcg in the presence and absence of mammalian metabolic activation using the plate-incorporation method.

 

Rosin, maleated was tested up to limit concentrations, and cytotoxicity was not reported. Based on the test conditions used in this study, rosin, maleated was not found to be mutagenic with or without metabolic activation regardless of strain or dose.The positive controls induced the appropriate responses in the corresponding strains.