Rosin, fumarated, reaction products with glycerol and pentaerythritol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study to standard protocol and subject to GLP audit

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Also included a test using one strain of E coli.

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, fumarated, reaction products with glycerol and pentaerythritol

EC Number:

296-047-1

EC Name:

Rosin, fumarated, reaction products with glycerol and pentaerythritol

Cas Number:

92202-14-7

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Ester of fumarated rosin with glycerol and pentaerythritol, consisting of mainly tri-esters, tetra-esters mixed glycerol- and pentaerythritol- esters and polyesters, as the reactor is charged with a 4:1 stoichiometric ratio of reactants (rosin/fumarated rosin with a glycerol pentaerythritol mixture), and reacted until a low ‘acid value’ is achieved, indicating that most of the –COOH groups of the parent rosin/fumarated rosin have been esterified.

Details on test material:

- Name of test material (as cited in study report): rosin, fumarated, reaction products with glycerol and pentaerythritol, CAS 92202-14-7
- Substance type: Chemically modified UVCB
- Physical state: solid
- Analytical purity: assumed 100%
- Lot/batch No.: AN-0400-60
- Expiration date of the lot/batch: March 2001
- Stability under test conditions: assumed stable
- Storage condition of test material: ambient, protected from light
- Other: Supplier - Arizona Chemical

Method

Target gene:

His D3052
His G46
Trp
His C3076

Species / strain

Species / strain 1

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Species / strain 2

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S-9 from Aroclor induced rats

Test concentrations with justification for top dose:

60, 190, 560, 1670, 5000 mcg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO;
- Justification for choice of solvent/vehicle: solubility

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

2-nitrofluorene, sodium azide, mitomycin, 2-aminoanthracene and 9-aminoacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION: Direct plate method

Bacterial suspension, test substance and PBS (or metabolic system) (triplicates) mixed with top agar and poured onto minimal agar medium plate. After solidification, the plate was incubated at 37 deg C .

Pre-incubation:

Bacterial suspension, test substance and PBS (or metabolic system) were mixed and incubarted for 20 min at 37 deg C. The mixture was then plated out and incubated as described for the plate incorporation assay.

NUMBER OF REPLICATIONS: 3 for each strain and dose level in both the presence and absence of S-9

NUMBER OF CELLS EVALUATED:

Cells counted in a colony counter

Evaluation criteria:

Sterility, cytotoxicity, positive controls to show valid increases (>2.5 fold) over background, positive and negative controls within the range expected from historical data, test item to have increased > 2 or 3 fold in revertants over control, dose response expected.

Results and discussion

Test results

Test results 1

Key result

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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:
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, or in E. coli strain WP2, with or without metabolic activation, rosin, fumarated, reaction products with glycerol and pentaerythritol 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 bacterial reverse mutation assay with Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 99, TA 100 and Escerichia coli WP2 uvrA conducted in accordance with Guideline protocols, rosin, fumarated, reaction products with glycerol and pentaerythritol CAS 92202 -14 -7 was negative when tested up to 5000 mcg/plate with and without metabolic activation. Concurrent positive controls gave the expected results.