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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
- Study performed according to OECD guideline 471 (Bacterial Reverse Mutation Assay) - Assessment supported with ToxRTool (Schneider K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10;189(2):138-44.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Remarks:
in agreement with OECD GLP principles from 1983
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Alcohols, C6-24, distn. residues
EC Number:
310-080-1
EC Name:
Alcohols, C6-24, distn. residues
Cas Number:
102242-49-9
IUPAC Name:
Alcohols, C6-24, distn. residues
Details on test material:
- Name of test material (as cited in study report): Lorol RG, neutral
- Physical state: beige solid (paste)

Method

Target gene:
uvrB
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 (Arcolor 1254 induced)
Test concentrations with justification for top dose:
8, 40, 200, 1000, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Tween 80/ bidist. water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80/bidist. water
Positive controls:
yes
Remarks:
for TA 1535 and TA 100 without S9
Positive control substance:
sodium azide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80/bidist. water
Positive controls:
yes
Remarks:
for TA 1537 without S9
Positive control substance:
9-aminoacridine
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80/bidist. water
Positive controls:
yes
Remarks:
for TA 1538 and TA 98 without S9
Positive control substance:
other: 4-nitro-o-phenyldiamine
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80/bidist. water
Positive controls:
yes
Remarks:
for all strains with S9
Positive control substance:
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar

Evaluation criteria:
Depending on strain, 2 or 3 fold increased rates of mutation as comaored to respective negative controls
Statistics:
no

Results and discussion

Test resultsopen allclose all
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:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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 (migrated information):
negative

In a study according to OECD test guideline 471, the test substance did not induced increased mutation rates and is therefore not considered to be mutagenic.
Executive summary:
The mutagenic potential of the test substance was investigated in a study according to OECD 471 (Ames) using the five strains TA 1535, 1537, 1538, 98 and 100 with and without metabolic activation. Five test substance concentration from 8 to 5000 µg/plate and adequate positive controls were applied in agar. No enhanced mutation rate in the S9 treated or untreated cells was observed in the Ames test. Therefore, the test substance was considered to be not mutagenic.