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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity of the test item was based on the data on genetic toxicity of tetradecanoic acid, used for the read-across since the test item is a reaction mass of tetradecanoic anhydride and tetradecanoic acid.
For tetradecanoic acid, data on genetic toxicity are published and no genotoxicity is reported, therefore also the test item is considered not genotoxic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1988
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Guideline:
- other: Information not available from the abstract
- GLP compliance:
- not specified
- Remarks:
- Information not available from the abstract
- Type of assay:
- other: Salmonella mutagenicity test
- Species / strain / cell type:
- other: Salmonella typhimurium
- Details on test system and experimental conditions:
- A preincubation protocol was used. All tests were performed in the absence of exogenous metabolic activation, and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters.
- Key result
- Species / strain:
- other: Salmonella typhimurium
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Conclusions:
- Result of Salmonella mutagenicity test on tetradecanoic acid : negative.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1988
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Justification for type of information:
- Since the test item is a reaction mass of tetradecanoic anhydride and tetradecanoic acid, tetradecanoic acid was used for the read-across.
- Reason / purpose for cross-reference:
- read-across source
- Guideline:
- other: Information not available from the abstract
- GLP compliance:
- not specified
- Remarks:
- Information not available from the abstract
- Type of assay:
- other: Salmonella mutagenicity test
- Species / strain / cell type:
- other: Salmonella typhimurium
- Details on test system and experimental conditions:
- A preincubation protocol was used. All tests were performed in the absence of exogenous metabolic activation, and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters.
- Key result
- Species / strain:
- other: Salmonella typhimurium
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Conclusions:
- Result of Salmonella mutagenicity test on tetradecanoic acid : negative.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Guideline:
- other: Information not available from the abstract
- GLP compliance:
- not specified
- Remarks:
- Information not available from the abstract
- Type of assay:
- other: Information not available from the abstract
- Key result
- Species / strain:
- not specified
- Remarks:
- information not available from the abstract
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Additional information on results:
- Myristic acid did not induce a mutagenic response in either bacterial or mammalian systems in vitro
- Conclusions:
- Myristic acid did not induce a mutagenic response in either bacterial or mammalian systems in vitro
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Justification for type of information:
- Since the test item is a reaction mass of tetradecanoic anhydride and tetradecanoic acid, tetradecanoic acid was used for the read-across.
- Reason / purpose for cross-reference:
- read-across source
- Guideline:
- other: Information not available from the abstract
- GLP compliance:
- not specified
- Remarks:
- Information not available from the abstract
- Type of assay:
- other: Information not available from the abstract
- Key result
- Species / strain:
- not specified
- Remarks:
- information not available from the abstract
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Additional information on results:
- Myristic acid did not induce a mutagenic response in either bacterial or mammalian systems in vitro
- Conclusions:
- Myristic acid did not induce a mutagenic response in either bacterial or mammalian systems in vitro
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
