Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Only TA97,TA98,TA100 and TA102 tested during the study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Version:1998
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc
- Test material form:
- liquid - solid: mixture of
- Remarks:
- water and Reaction products of 2-hydroxybenzoic acid and styrene and zinc oxide
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared according to the method of Ams in department of genetic toxicology of IOM,CAMP and stored at -80℃ for use.
- Test concentrations with justification for top dose:
- According to results of inhibition test on bacteria TA 100, the dosages of test substance were 1000 μg/plate,500 μg/plate,250 μg/plate,125 μg/plate and 62.5 μg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile deionized water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- methylmethanesulfonate
- other: 2,4,7-trinitro-9-flourenone and 2-hydroxy anthraquinone
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration:triplicate
- Number of independent experiments:1
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 10*8
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable:16 hours
- Exposure duration/duration of treatment:48 hours
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- other: not available as the study was conducted according to old version of Test Guideline
- Remarks:
- not available
- Cytotoxicity / choice of top concentrations:
- other: not available as the study was conducted according to old version of Test Guideline
- Vehicle controls validity:
- other: not available as the study was conducted according to old version of Test Guideline
- Untreated negative controls validity:
- other: not available as the study was conducted according to old version of Test Guideline
- True negative controls validity:
- other: not available as the study was conducted according to old version of Test Guideline
- Positive controls validity:
- other: not available as the study was conducted according to old version of Test Guideline
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No clear signs of cytotoxicity and precipitation were observed.Compared with the historical data, the numbers of reverent colonies per plate of blank and positive control for the 4 bacterial strains were all in the acceptable ranges.Neither a concentration-related increase over the range tested and a reproducible increase at one or more concentrations in the number of reverent colonies per plate in at least on strain with and withour metabolic activation system were found.
Applicant's summary and conclusion
- Conclusions:
- The substanse is not mutagenic in the Salmonella Typhimurium.
- Executive summary:
In a Bacterial Reverse Mutation Test according to OECD TG 471(version:1998), TA 97, TA98 TA100 and TA 102 were utilized to detect the gene mutation potential of the test item in the absence and presence of S9 activation system.No clear signs of cytotoxicity and precipitation were observed.Compared with the historical data, the numbers of reverent colonies per plate of blank and positive control for the 4 bacterial strains were all in the acceptable ranges.Neither a concentration-related increase over the range tested and a reproducible increase at one or more concentrations in the number of reverent colonies per plate in at least on strain with and withour metabolic activation system were found. The substanse is considered as not mutagenic in the Salmonella Typhimurium.
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