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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited reporting).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
OECD Guidelines recommend using TA 102 or E. coli to detect cross-linking/oxidising agents.
Principles of method if other than guideline:
An in-house protocol similar to OECD No. 471
GLP compliance:
not specified
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): Lorol C8 (tradename)
- Substance type: monoconstituent substance
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Target gene:
Histidine
Species / strain
Species / strain:
other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9
Test concentrations with justification for top dose:
4, 20, 100, 500, and 2500 µg/plate
Controls
Negative controls:
not specified
Solvent controls:
yes
Remarks:
Water/Tween 80
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (5 µg/plate), sodium azide (1 µg/plate), 4-nitro-o-phenylenediamine (40 µg/plate)
Details on test system and conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: Four per dose level.
Evaluation criteria:
No data

Results and discussion

Test results
Species / strain:
other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
other: 2500 µg/plate for all strains, 500 µg/plate for some strains (see text)
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not reported

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- With metabolic activation: Total inhibition of bacterial growth at 2500 ug/plate for all strains tested; also at 500 ug/plate for strains TA1537, TA1538 and TA98.
- Without metabolic activation: Total inhibition of bacterial growth at 2500 ug/plate for all strains tested; also at 500 ug/plate for strains TA1538 and TA98.

Applicant's summary and conclusion

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

In a reliable study, using a method similar to OECD test guideline 471, C8 alcohol Lorol C8 at concentrations up to 2500 µg/plate did not increase the reverse mutation rate in five histidine dependent bacterial strains of Salmonella typhimurium, in the presence or absence of a mammalian liver metabolic activation system (S9). Cytotoxicity was observed at the highest concentration tested.