Alcohols, C6-24 and C6-24-unsatd., distn. residues

Genetic toxicity: in vitro

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

Test material information

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 / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

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

Controls

Controls 1

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

Controls 2

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

Controls 3

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

Controls 4

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 results

Test results 1

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

Test results 2

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.