Registration Dossier
Registration Dossier
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EC number: 286-061-6 | CAS number: 85186-76-1
Genetic toxicity: in vivo
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across category
Data source
Materials and methods
Test material
- Test material form:
- liquid
Constituent 1
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results from key studies on source chemicals of the category for in vivo mutagenicity tests.
ID# |
CAS |
In vivo mutagenicity test |
Fatty acids, C8-16, 2- |
135800-37-2 |
Experimental |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
No data |
2-Ethylhexyl palmitate |
29806-73-3 |
No data |
Fatty acids, C16-18 and C18-unsatd., 2- |
85049-37-2 |
No data |
Fatty acids, C16-18, 2-ethylhexyl esters |
91031-48-0 |
No data |
2-Ethylhexyl oleate |
26399-02-0 |
No data |
2-Ethyl hexyl stearate |
22047-49-0 |
No data |
Similar toxicokinetic behavior and toxicity profile
All category members are subject to enzymatic hydrolysis by pancreatic lipases resulting in free acids and alcohol. Based on current literature, when absorbed from intestines and carried through blood stream, fatty acids are oxidized by beta-oxydation pathway in order to provide energy for cell and stored as glycerides esters in fat deposit. The alcohols are primarily metabolized in the liver.
Hence, it can be stated that the members of the category have the same toxicity due to the same metabolic pathways when absorbed in the organisms.
Based on the available data for in vivo micronucleus test, no genotoxicity was observed on the tested source substance including in the category. Hence, according to the physico-chemical similarities between the substances of the category, the registered substance 2-ethylhexyl isostearate could be considered as not genotoxic in in vivo micronucleus test.
Applicant's summary and conclusion
- Conclusions:
- Based on the available data for in vivo micronucleus test, no genotoxicity was observed. Hence, the registered substance 2-ethylhexyl isostearate could be considered as not genotoxic in in vivo micronucleus test
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