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Toxicological information

Genetic toxicity: in vitro

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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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.