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REACH

Phenol, styrenated, epoxidized

EC number: 935-721-8 | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Phenol styrenated epoxidised [EC No. 935-721-8] is mutagenic in the bacterial gene mutation assay (Ames, OECD 471). No mutagenic activity was found in the corresponding gene mutation assay in mammalian cell culture (HPRT, OECD 473).

Link to relevant study records

Reference

Endpoint:: in vitro gene mutation study in bacteria
Remarks:: Type of genotoxicity: gene mutation
Type of information:: experimental study
Adequacy of study:: key study
Study period:: 2012, July 17 - 2012, Sep 19
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: other: GLP study according to guidelines
Qualifier:: according to guideline
Guideline:: OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:: according to guideline
Guideline:: EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:: yes (incl. QA statement)
Type of assay:: bacterial reverse mutation assay
Species / strain / cell type:: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:: not applicable
Species / strain / cell type:: E. coli WP2 uvr A
Additional strain / cell type characteristics:: not applicable
Metabolic activation:: with and without
Metabolic activation system:: Rat liver homogenate metabolising system (10 % liver S9 in standard co-factors
Test concentrations with justification for top dose:: Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/plate
Mutation Test (Experiment 1): 5, 15, 50, 150, 500, 1500, 5000 µg/plate in triplicate
Vehicle / solvent:: - Vehicle(s)/solvent(s) used: Dimethyl sulphoxide
- Justification for choice of solvent/vehicle: The test item was immiscible in sterile distilled water at 50 mg/ml but was fully miscible in
dimethyl sulphoxide at the same concentration in solubility checks performed in-house.
Untreated negative controls:: yes
Negative solvent / vehicle controls:: yes
True negative controls:: no
Positive controls:: yes
Positive control substance:: 4-nitroquinoline-N-oxide; 9-aminoacridine; N-ethyl-N-nitro-N-nitrosoguanidine; benzo(a)pyrene; other: 2-Aminoanthracene
Remarks:: see details below
Details on test system and experimental conditions:: METHOD OF APPLICATION: in agar (plate incorporation)
- Preliminary toxicity test: The test was performed by mixing 0.1 ml of bacterial culture (TA100 or WP2uvrA), 2 ml of molten, trace histidine or
tryptophan supplemented, top agar, 0.1 ml of test item formulation and 0.5 ml of S9-mix or phosphate buffer and overlaying onto sterile plates of Vogel-Bonner Minimal agar (30 ml/plate).
Ten concentrations of the test item formulation and a vehicle control (dimethyl sulphoxide) were tested.
After approximately 48 hrs incubation at 37°C the plates were assessed for numbers of revertant colonies using a colony counter and examined
for effects on the growth of the bacterial background lawn.

- Mutation Test (Experiment 1): Aliquots (0.1 ml) of one of the bacterial cultures were dispensed into sets of test tubes followed by 2 ml of molten,
trace histidine or tryptophan supplemented, top agar, 0.1 ml of the vehicle, test item formulation or positive control and either 0.5 ml of S9-mix or phosphate buffer.
The contents of each test tube were mixed and equally distributed onto the surface of Vogel-Bonner Minimal agar plates (one tube per plate).
This procedure was repeated, in triplicate, for each bacterial strain and for each concentration of test item both with and without S9-mix.
All of the plates were incubated at 37°C for approximately 48 hours and the frequency of revertant colonies assessed using a colony counter.

NUMBER OF REPLICATIONS: 3 per dose level, with and without metabolic activation (+S9 and -S9)

DETERMINATION OF CYTOTOXICITY
- Method: colony growth (background lawn)
Evaluation criteria:: Criteria for determining a positive result: Any, one, or all of the criteria can be used to determine the overall result of the study:
- A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
- A reproducible increase at one or more concentrations.
- Biological relevance against in-house historical control ranges.
- Statistical analysis of data as determined by UKEMS [Mahon et al (1989)].
- Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
- A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.

The reverse mutation assay may be considered valid if the following criteria are met:
- All bacterial strains must have demonstrated the required characteristics as determined by their respective strain checks according to Ames et al (1975),
Maron and Ames (1983) and Mortelmans and Zeiger (2000).
- All tester strain cultures should exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
(Acceptable ranges are presented in the report in the General Study Plan, Section 4 (negative controls)).
- All tester strain cultures should be in the range of 0.9 to 9 x 109 bacteria per ml.
- Diagnostic mutagens (positive control chemicals) must be included to demonstrate both the intrinsic sensitivity of the tester strains to mutagen exposure
and the integrity of the S9-mix. All of the positive control chemicals used in the study should induce marked increases in the frequency of revertant
colonies, both with or without metabolic activation.
- There should be a minimum of four non-toxic test item dose levels.
- There should be no evidence of excessive contamination.
Species / strain:: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:: with and without
Genotoxicity:: positive
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:: TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A test item precipitate (oily in appearance) was noted at 5000 µg/plate. Also a creamy film was observed at and above 1500 µg/plate.
Neither of these observations prevented the scoring of revertant colonies.

COMPARISON WITH HISTORICAL CONTROL DATA: Historical laboratory control data from 2010 and 2011 are documented in appendix 2 of the report
(History Profile of Vehicle and Positive Control Values)

ADDITIONAL INFORMATION ON CYTOTOXICITY: The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level.
Remarks on result:: other: all strains/cell types tested
Remarks:: Migrated from field 'Test system'.
Conclusions:: Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation

The test item, Novares LR 600, was considered to be mutagenic under the conditions of this test.

Endpoint conclusion

Endpoint conclusion:: adverse effect observed (positive)

Additional information

Justification for classification or non-classification

Based on current findings, no classification for mutagenic potential is required.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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S9-mix	Strain	Dose (µg/plate)
S9-mix	Strain	0	0.15	0.5	1.5	5	15	50	150	500	1500	5000
-	TA100	99	90	90	70	96	144	240	434	548	632F	804FP
+	TA100	91	76	86	90	88	122	155	229	323	644F	695FP
-	WP2uvrA	38	27	33	37	30	37	47	62	93	95F	124FP
+	WP2uvrA	34	45	34	37	45	34	60	36	45	56F	75FP