Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 286-061-6 | CAS number: 85186-76-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
Based on the read-across category approach and the available experimental result, the NOAEL value for embryo- and maternotoxicity was defined as 1000 mg/kg bw/day. Hence, the registered substance is not classified for teratogenicity.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: Available study for read across category
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Basedon available study for read across category approach
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- According to the results of the available studies for LCAE Category members, the NOAEL for materno and embryotoxicitywas defined at 1000 mg/kgbw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for teratogenicity.
Reference
Table 1: Results from key studies on source chemicals of the category for teratogenicity tests.
ID# |
CAS |
Toxicity to reproduction – |
Fatty acids, C8-16, 2- |
135800-37-2 |
No data |
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 |
NOAEL 1000 mg/kgbw/day |
2-Ethylhexyl oleate |
26399-02-0 |
No data |
2-Ethylhexyl stearate |
22047-49-0 |
NOAEL: |
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-oxydationpathway 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.
Two studies for the developmental toxicity were available within the LCAE C8 to C18, for the category members 2-ethylhexyl stearate and Fatty acids, C16-18 2-ethylhexyl esters. (OECD 414 method for Teratogenicity test performed in rat). They did not show treatment related effects up to the highest tested dose level. Thus, no hazard for developmental toxicity was identified. The NOAEL forembryotoxicityandmaternotoxicitywas defined at 1000 mg/kgbw/day.
According to the results of the available studies for LCAE Category members, the NOAEL for materno- and embryo- toxicity was defined at 1000 mg/kgbw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for teratogenicity.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Justification and rationale of the category approach for the isostearate ethyl hexyl :
This category group covers 2-ethyl hexyl esters linked with fatty acid chains (C8 to C18) unsatured and satured. This category includes monoconstituent substances and UVCB substances varying fatty acid chain length. This category was made in order to provide sufficient information for physicochemical, ecotoxicological and toxicological caracterisation of the Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters (CAS No 85186-76-1)
The category group includes:
- 2-Ethyl hexyl stearate (CAS No 22047-49-0)
- Fatty acids, C8-16, 2-ethylhexyl esters (CAS No 135800-37-2)
- Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS No 85049-37-2)
- Fatty acids, coco, 2-ethylhexyl esters (CAS No 92044-87-6)
- Fatty acids, C16-18, 2-ethylhexyl esters (CAS No 91031-48-0)
- Fatty acids, C8-16, 2-ethylhexyl esters (CAS No 135800-37-2)
- 2-Ethylhexyl oleate (CAS No 26399-02-0)
Target substance for Category Approach : Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters (CAS No 85186-76-1)
In accordance with article 13 (1) of Regulation (EC) No. 1907.2006, “information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, environmental fate and ecotoxicity, information shall be generated whenever possible by means other than vertebrate animal tests which includes the use of information from structurally related substances (grouping or read across)”. Therefore, the available experimental data were collected and evaluated according to Annex XI requirements.
Summary of the available studies
Fatty acids, C16-18, 2-ethylhexyl esters CAS 91031-48-0
A Prenatal Developmental Toxicity Study was performed with the fatty acids, C16-18, 2-ethylhexyl esters according to OECD Guideline 414 (Pittermann, 1994). Groups of 24 female Sprague-Dawley rats received daily oral gavage doses of the test substance in arachidis oil at concentrations of 0, 100, 300 and 1000 mg/kg bw/d during gestational days 6 to 15. On day 20 of gestation the animals were euthanized and examined for maternal and foetal parameters. Based on the number of implantations, number of total litter losses by resorption, mortality, clinical signs, body weight, gross pathology and organ weights of maternal animals the NOAEL for maternal toxicity was found to be 1000 mg/kg bw/d. Examination of foetus litter size and weights, offspring viability (number alive and number dead), sex ratio, grossly visible abnormalities, external, soft tissue and skeletal abnormalities and head examinations showed no abnormalities and no indication for teratogenic effects. Therefore, the NOAEL for embryo-foetotoxicity and teratogenicity in rats for fatty acids, C16-18, 2-ethylhexyl esters was found to be 1000 mg/kg bw/d.
2 -ethylhexyl stearate CAS 22047-49-0
The developmental toxicity of 2-Ethylhexyl Stearate was investigated according to OECD Guideline 414 and GLP conditions (Aulmann, 2000). Groups of 24 female Sprague-Dawley rats received daily oral gavage doses of the test substance in arachidis oil at dose levels of 0, 100, 300 and 1000 mg/kg bw/d during gestational days 6 to 15. On day 20 of gestation the animals were euthanized and examined for maternal and fetal parameters. Based on the number of implantations, number of total litter losses by resorption, mortality, clinical signs, body weight, gross pathology and organ weights of maternal animals the NOAEL for maternal toxicity was found to be 1000 mg/kg bw/d. Examination of fetus litter size and weights, offspring viability (number alive and number dead), sex ratio, grossly visible abnormalities, external, head, soft tissue and skeletal abnormalities showed no differences to control and no indication for teratogenic effects. Therefore, the NOAEL for embryo-/fetotoxicity and teratogenicity in rats for 2-Ethylhexyl Stearate was found to be 1000 mg/kg bw/day.
According to the results of the available studies for LCAE Category members, the NOAEL for materno and embryotoxicity was defined at 1000 mg/kg bw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for teratogenicity.
Justification for classification or non-classification
Additional information
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.