Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
SCREENING OF TOBACCO SMOKE CONSTITUENTS FOR MUTAGENICITY USING THE AMES' TEST
Author:
Florin, I., Rutberg, L., Curvall, M. and Enzell, C.R.
Year:
1980
Bibliographic source:
Toxicology, 18 (1980) 219-232

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Target gene:
TA98, TA100, TA1537, TA98 and TA100
Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
other: histadine requiring
Metabolic activation:
with and without
Test concentrations with justification for top dose:
3 µmol/plate
Vehicle:
Spectroscopic grade ethanol
Controls
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-aminoanthracene
Details on test system and conditions:
The S-9 mix contained per ml: 100 µmol sodium phosphate buffer (pH 7.4), 8 µmol MgC12, 33 µmol KC1, 5 µmol glucose 6-phosphate, 4 µmol NADP, and 0.03-0.1 ml S-9.
Statistics:
Not specified.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: All strains (TA 1535, TA 1537, TA 98 and TA 100) tested

Applicant's summary and conclusion

Conclusions:
2-phenylethanol is not mutagenic.
Executive summary:

The mutagenic activity of 239 individual components of tobacco smoke (including 2-phenylethanol) was assessed using the Ames test. The bacterial strains TA 1535, TA 98 and TA100 of S. typhimurium were used with and without metabolic activation using liver fraction S-9. 2 -phenylethanol was shown to be not mutagenic.