Registration Dossier
Registration Dossier
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EC number: 269-923-6 | CAS number: 68391-04-8 This substance is identified by SDA Substance Name: C12-C18 alkyl dimethyl amine and SDA Reporting Number: 16-040-00.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Reliable data from several guideline studies on in-vitro gene-mutation in bacterial cells are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18 DMA and C18-DMA. Four reliable in-vitro cytogenetic studies in mammalian cells are available for C10-DMA, C16-DMA, C12-18 DMA and for C18-DMA. In addition, six in-vitro gene mutation studies in mammalian cells are available for the substances C10-DMA, C12-14-DMA, C16-DMA, C12-18 DMA and C18-DMA (all studies are reliable). Further one reliable in vivo cytogenetic study according to OECD TG 474 is available for C12-14-DMA. All studies demonstrate a lack of genotoxic activity of DMAs. Therefore, no classification according to Regulation (EC) No. 1272/2008 is warranted.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.
- Type of assay:
- bacterial reverse mutation assay
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- at 0.0005 up to 0.05 µL/mL. Based on initial cytotoxicity test 0.05 µL/plate selected as highest test concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- at 0.0005 up to 0.05 µL/mL. Based on initial cytotoxicity test 0.05 µL/plate selected as highest test concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- at 0.0005 up to 0.05 µL/mL. Based on initial cytotoxicity test 0.05 µL/plate selected as highest test concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- at 0.0005 up to 0.05 µL/mL. Based on initial cytotoxicity test 0.05 µL/plate selected as highest test concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 0.05 µL/plate to 5 µL/plate +/- S9 mix. Based on initial cytotoxicity test 0.05 µL/plate selected as highest test concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Results presented above were obtained with the source substance C18-DMA.
- Executive summary:
The study used as source investigated the in vitro gene mutation potential of C18-DMA in bacteria. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.
- Type of assay:
- micronucleus assay
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- in the highest dose group: motor activity decreased, diarrhea, palpebral fissure narrow, movements uncoordinated, stupor, tonic convulsion, and prone position
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Executive summary:
The study used as source investigated in vivo cytogenicity of C12-14 DMA. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.
Reference
Results presented above were obtained with the source substance C12-14 DMA.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Eleven reliable in-vitro gene-mutation studies (reliability 1 or 2) in bacteria are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18 DMA and C18-DMA. All studies were performed according to the OECD TG 471. The results of these studies are comparable, demonstrating no mutagenic potential of DMAs.
Four in-vitro cytogenetic studies in mammalian cells are available for C10-DMA, C16-DMA, C12-18 DMA and for C18 -DMA. In addition, six in-vitro gene mutation studies in mammalian cells are available for the substances C10-DMA, C12-14-DMA, C16-DMA, C12-18 DMA and C18-DMA. All of these studies were performed according to OECD Guideline 473 or 476 respectively and merit Klimisch rating of 1. No mutagenic/no clastogenic potential was found. Based on the results obtained is not expected that the chain length variation influences the genotoxicity of DMAs.
Further one reliable (reliability 1) in vivo cytogenetic study according to OECD TG 474 is available for C12-14-DMA, demonstrating lack of genotoxic activity of DMAs in vivo as well.
All in all, data on genotoxicity are consistent. In vitro as well as in vivo data showed no genotoxic potential for the members of this category.
No classification according to Regulation (EC) No. 1272/2008 is warranted to members of DMAs and no further testing is needed.
Justification for classification or non-classification
In a reliable set of bacterial mutation assays, gene mutation studies in mammalian cells, and in vitro cytogenicity tests and one in vivo mutagenicity test, the DMAs of this category did not exert mutagenic or clastogenic activity.
Based on the available data no classification for mutagenicity according to Regulation (EC) No. 1272/2008 is necessary.
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