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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the potential effects of ingredients added to cigarettes. Part 3: In vitro genotoxicity and cytotoxicity*
Author:
E. Roemera, F.J. Tewesa, T.J. Meisgena, D.J. Veltela, E.L. Carminesb
Year:
2002
Bibliographic source:
Food and Chemical Toxicology 40 (2002) 105–111

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
In vitro genotoxicity study of cigarette smoke (Anisyl Formate) by using Salmonella plate incorporation (Ames) assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Anisyl formate
EC Number:
204-582-9
EC Name:
Anisyl formate
Cas Number:
122-91-8
Molecular formula:
C9H10O3
IUPAC Name:
(4-methoxyphenyl)methyl formate
Test material form:
liquid
Details on test material:
Details on test material
- Name of test material (as cited in study report): Anisyl Formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mole
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
Details on test material
- Name of test material (as cited in study report): Anisyl Formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mole
- Substance type: Organic
- Physical state: Liquid

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA102, TA1535 and TA1537.
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
Not applicable.
Metabolic activation:
with and without
Metabolic activation system:
Metabolic activation system consisting of the postmitochondrial fraction of the livers from rats treated with Aroclor 1254
Test concentrations with justification for top dose:
0, 1, 2, 3, 4, 5 and 5 mg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: In agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: 44–48 h.
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): Mouse embryo BALB/c 3T3 cells

NUMBER OF REPLICATIONS: 3

NUMBER OF CELLS EVALUATED: 5

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Neutral red uptake assay

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Rationale for test conditions:
Not specified
Evaluation criteria:
Number of His+ revertant colonies was determined
Statistics:
Arithmetic means and measures of variance were calculated as descriptive statistics. The one-way analysis of variance was used to compare the results obtained for the control cigarette and those obtained for the test cigarettes containing the same group of ingredients. In those cases where this overall comparison showed a significant difference between the cigarettes, the Duncan test (Duncan, 1955) for pairwise comparison was applied. Results were considered to be statistically significant at P40.05 without adjustment for multiple testing.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA98, TA100, TA102, TA1535 and TA1537.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA: Yes

Applicant's summary and conclusion

Conclusions:
Anisyl Formate did not induce mutagenicity in an Ames assay conducted on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains with and without rat liver S9 activation.
Executive summary:

Genetic toxicity in vitro study was assessed forAnisyl Formate(122-91-8) to evaluate its possible mutagenic potential .For this purpose AMES assay was performed according to guideline OECD 471.Anisyl Formate was exposed toS. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains with and without rat liver S9 activation byplate incorporation assay at the concentration of0, 1, 2, 3, 4, 5 and 5 mg/plate. DMSO was used as solvent. Negative and positive control were used .Anisyl Formatedid not induce mutagenicity in an Ames assay conducted on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains with and without rat liver S9 activation byplate incorporation assay .Although positive response is observed in some strains, there were also no apparent trends discernible that would suggest a change in mutagenic activity caused by the addition of the ingredient chemicals. ThereforeAnisyl Formate(122-91-8) was not likely to classify as gene mutant in vitro.