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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: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Principles of method if other than guideline:
Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals; Guideline
no. 471: "Genetic Toxicology: Bacterial Reverse Mutation
Test". (adopted July 21, 1997).


European Economic Community (EEC). Directive 2000/32/EC,
Part B: Methods for the Determination of Toxicity; B.13/14:
"Mutagenicity: (Reverse Mutation Test using bacteria". EEC
Publication Commission Directive (Published June 8, 2000).


Guideline stipulated by the Japanese Ministry of Health,
Labour and Welfare, Ministry of Economy, Trade and Industry
and Ministry of the Environment (revised April 30, 2004).
GLP compliance:
yes (incl. certificate)
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): TC4ASO2
- Substance type: multi-constituent
- Physical state: white powder
- Analytical purity: 97.8%
- Composition of test material, percentage of components: 92.9% 4-tert-Butylsulfonylcalix(4)arene (CAS 204190-49-8)
4.9% 4-tert-Butylsulfonylcalix(8)arene
- Lot/batch No.: AYUI-1Y
- Expiration date of the lot/batch: 07 October 2007
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium (TA1535, TA1537, TA98 and TA100). Escherichia coli (WP2uvrA).
Metabolic activation system:
Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 10 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Dimethyl sulfoxide
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
dimethyl sulfoxide
Positive controls:
yes
Remarks:
see below
Positive control substance:
other: see below
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 1000 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Observations:
All bacterial strains showed negative responses over the
entire dose range, i.e. no significant dose-related increase
in the number of revertants in two independently repeated
experiments.
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Comments:
At concentrations <= 10 mg/ml the test substance was
dissolved in the vehicle. At concentrations >= 33 mg/ml the
test substance was suspended in the vehicle.


In the first and second experiment 5% (v/v) and 10% (v/v) of
S9-mix was used, respectively.

Applicant's summary and conclusion

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