Registration Dossier
Registration Dossier
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EC number: 242-149-6 | CAS number: 18268-70-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There is no genetic toxicity information available for the test substance. An Ames mutagenicity study with the structurally similar ethane-1,2-diylbis(oxyethane-2,1-diyl) bisheptanoate (CAS 7434 -40 -4) was negative when tested in Salmonella strains TA98, TA100, TA1535, TA1537 and TA1538 up to a maximum plate incorporation level of 5000 uL/plate, either with or without metabolic activation.
The structurally similar material, heptanoic acid, oxybis(2,1-ethanediyloxy-2,1-ethanediyl) ester (CAS 70729 -40 -9), was negative in a CHO HGPRT mammalian cell mutagenicity study either with or without metabolic activation.
The structurally similar material, heptanoic acid, ester with 2,2,4-trimethyl-1,3-propanediol (CAS 71839 -38 -8), was negative in a mammalian cell chromosomal aberration test with human lymphocytes at test concentrations up to 5000 ug/mL, either with or without metabolic activation.
Link to relevant study records
- Endpoint:
- genetic toxicity in vitro, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- The subject material is a member of a US HPV Glycol Esters category.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- other: the subject material is of low concern for in vitro genotoxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance is a member of a category of aliphatic esters submitted by The American Chemistry Council's (ACC) Aliphatic Esters Panel (Panel) under the High Production Volume (HPV) Chemical Challenge Program (ACC, 2003). Information from a Screening Information Data Set (SIDS) developed in that program serves as supplementary or weight-of-evidence in the current dossier. Category ester compounds with similar structures and functionalities were of low potential for mutagenicity. Ames mutagenicity tests are available for the structurally similar substances, heptanoic acid, oxybis(2,1-ethanediyloxy-2,1-ethanediyl) ester (CAS 70729 -40 -9), and heptanoic acid, ester with 2,2,4-trimethyl-1,3-propanediol (CAS 71839 -38 -8). The test substance CAS 70729 -40 -9 was negative in Salmonella strains TA 1535, TA 1537, TA 98 and TA 100, either with or without metabolic activation. The test substance CAS 71839 -38 -8 was also negative in Salmonella strains TA 1535, TA 1537, TA 98 and TA 100, either with or without metabolic activation.
Justification for classification or non-classification
Based on the results of in vitro genetic toxicity testing of structurally similar substances, the test substance would not be classified for mutagenicity according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.
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.
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