Substance Data


Safety information on chemicals is from the results of the existing chemicals survey program conducted by the Japanese Government (Ministry of Health, Labour and Welfare, 
Ministry of Economy, Trade and Industry, and Ministry of the Environment).

User should check the details with the original report(in Jpanenese) for confirmation. 

Data may not be evaluated or assessed by expert and confirmation of test results is needed if these data are used for assessment.

Some of Year in DATA SOURCE means tested year (financial year).



Endpoints

#70: Genetic toxicity in vitro


Administrative data
         Purpose flag :
         Data waiving :
         Justification for data waiving :
         Study result type :experimental result
         Study period :
         Reliability :1 (reliable without restriction)
         Rationale for reliability incl. deficiencies :
DATA SOURCE
       Reference
         Reference type:other:
         Reference type:Data sheet (published in 2004), prepared by Hazard-Data Assessment Committee of National Institute of Technology and Evaluation (NITE) based on the GLP study report obtained by NITE
         Owner company:National Institute of Technology and Evaluation
MATERIALS AND METHODS
         Type of genotoxicity:gene mutation
         Type of study:bacterial reverse mutation assay (e.g. Ames test)
       Test guideline
         Qualifier:according to
         Guideline:OECD Guideline 471 (Bacterial Reverse Mutation Assay)
         GLP compliance:yes (incl. certificate)
   Test materials
       Test material identity
         Identifier:CAS RN
         Identity:4435-53-4
         Identifier:common name
         Identity:3-Methoxybutyl acetate
         Details on test material:- Molecular weight: 146.19 / - Molecular formula: C7H14O3 / - Purity: 99.8 %
   Method
       Species/strain
         Species/strain:S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
         Metabolic activation:with and without
         Metabolic activation system:S9mix(+)
         Species/strain:E. coli WP2 uvr A
         Metabolic activation:with and without
         Metabolic activation system:S9mix(+)
         Test concentrations:S9mix(-), (+): TA98, TA100, TA1535, TA1537, WP2uvrA; 0, 156, 313, 625, 1250, 2500, 5000 microg/plate
         Vehicle:Water
       Controls
         Positive controls:yes
         Positive controls:S9mix(-); ENNG (TA100, TA1535, WP2uvrA), 2-NF (TA98), 9-AA (TA1537) / S9mix(+); 2-AA (TA98, TA100, TA1535, TA1537, WP2uvrA)
         Remarks:ENNG: N-Ethyl-N'-nitro-N-nitrosoguanidine / 2-NF: 2-Nitrofluorene / 9-AA: 9-Aminoacridine / 2-AA: 2-Aminoanthracene
         Details on test system and conditions:- Procedure: Preincubation method / - Number of plates: 3 plates per test / - Number of replications: 2
RESULTS AND DISCUSSION
       Test results
         Species/strain:S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
         Metabolic activation:with and without
         Genotoxicity:negative
         Species/strain:E. coli WP2 uvr A
         Metabolic activation:with and without
         Genotoxicity:negative
         Any other information on results incl. tables:

Test results: Negative

OVERALL REMARKS, ATTACHMENTS
       Attached background material
       Attached full study report
APPLICANT'S SUMMARY AND CONCLUSION
       Interpretation of results

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