Registration Dossier
Registration Dossier
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EC number: 907-578-1 | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
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:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.14 (Ames-Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (S9 liver microsomal fraction induced with Phenobarbital and beta-Naphtoflavone)
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 31.6 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 μg/plate - Vehicle / solvent:
- - Solvent used: DMSO (Dimethylsulfoxide)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Additional information on results:
- Observations
No toxic effecrs of the test item were observed in both experiments up to the highest investigated concentration in all strains used.
No substantial increases in the revertant colony numbers of any of the five test strains were detected at any dose level of the test item either with or without metabolic activation in both independently performed experiments.
As positive controls reference mutagens were tested in parallel to the test item. They showed a distinct increase of induced revertant colonies. Therefore, the validity and sensitvity of the test system was given. - Remarks on result:
- other: Test system other: preliminary test
- Conclusions:
- In conclusion, the test item was negative with and without metabolic activation.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.14 (Ames-Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 433-100-1
- EC Name:
- -
- IUPAC Name:
- Reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and lithium hydroxide
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (S9 liver microsomal fraction induced with Phenobarbital and beta-Naphtoflavone)
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 31.6 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 μg/plate - Vehicle / solvent:
- - Solvent used: DMSO (Dimethylsulfoxide)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Additional information on results:
- Observations
No toxic effecrs of the test item were observed in both experiments up to the highest investigated concentration in all strains used.
No substantial increases in the revertant colony numbers of any of the five test strains were detected at any dose level of the test item either with or without metabolic activation in both independently performed experiments.
As positive controls reference mutagens were tested in parallel to the test item. They showed a distinct increase of induced revertant colonies. Therefore, the validity and sensitvity of the test system was given. - Remarks on result:
- other: Test system other: preliminary test
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item was negative with and without metabolic activation.
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