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EC number: 211-016-4 | CAS number: 627-89-4
- 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
Description of key information
Repeated dose toxicity, oral (OECD 407), rat: NOAEL =1000 mg/kg bw/day (RA CAS 110-27-0)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in the toxicological profile. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are only limited data available on repeated dose toxicity of isopentyl oleate (CAS 627-89-4). In order to fulfil the standard information requirements set out in Annex VIII, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. 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, 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). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of repeated dose toxicity
CAS |
Chemical name |
Molecular weight [g/mol] |
Repeated dose toxicity Oral |
627-89-4 (a) |
Isopentyl oleate |
326.56 - 354.61 |
RA: CAS 110-27-0 RA: CAS 91031-48-0 |
110-27-0 (b) |
Isopropyl myristate |
270.46 |
Experimental result: NOAEL =1000 mg/kg bw/day (rat) |
91031-48-0 (b) |
Fatty acids, C16-18, 2-ethylhexyl esters |
368.65 – 396.7 |
Experimental result: NOEL =1000 mg/kg bw/day (rat) |
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
The above mentioned substance is considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for isopentyl oleate (CAS 627-89-4). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
No data on repeated dose toxicity is available with isopentyl oleate (CAS 627-89-4). Therefore, read across from the structurally analogue substances isopropyl myristate (CAS 110-27-0) and fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) was applied.
Repeated dose toxicity (oral)
CAS 110-27-0
A reliable key repeated dose toxicity study (28-day) with isopropyl myristate (CAS 110-27-0) is available and was performed equivalent or similar to OECD TG 407 (Gloxhuber, 1983). Only limited details on test substance purity are available. Groups of 10 Wistar rats of each sex were administered the test material at doses of 100, 500 and 1000 mg/kg bw/day or vehicle alone (olive oil) via oral gavage for 28 days on 5 consecutive days per week. Five additional animals per sex per dose were included as recovery group for analysis of possible post-exposure reversibility of intoxication symptoms. Urinalysis, neurobehavioural examinations and ophthalmoscopy were not performed.
Clinical observations, body weight changes, haematology, clinical chemistry, organ weight measurements as well as gross and histopathological examinations revealed no treatment-related abnormalities or adverse effects. Histopathology revealed hyperplastic changes in the non-glandular stomach of treated and control animals. Manifest mucosal hyperplasia was found in animals of the highest dose group. In few cases the mucosal hyperplasia was found combined with a submucosal inflammatory edema. In the recovery group these findings were not present in the non-glandular stomach, indicating the reversibility of the changes. The changes were judged to be induced by the olive oil used as vehicle and not by the test substance itself. Therefore, no treatment-related changes were observed. Based on the results of the study and due to the absence of any toxicological relevant adverse effect a subacute NOAEL of 1000 mg/kg bw/day was derived for isopropyl myristate.
CAS 91031-48-0
Another repeated dose toxicity study (28-day) with fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) is available and was performed equivalent or similar to OECD TG 407 (Pittermann, 1992). Only limited information on test substance purity is available. Urinalysis and neurobehavioural examination were not performed. Groups of 10 Sprague-Dawley rats of each sex were administered the test material at doses of 100, 500 and 1000 mg/kg bw/day or vehicle alone (peanut oil) via oral gavage for 28 days on 5 consecutive days per week. Five additional animals per sex were included in the control and highest dose group as recovery group for analysis of possible post-exposure reversibility of intoxication symptoms. In addition, 5 male and 5 female animals were used to determine the reversibility of possible compound-related findings (recovery group). All doses applied were tolerated without lethality. No compound-related effects were observed based on clinical signs, food consumption, water intake, body weight gain, haematological and clinical chemistry examinations, ophthalmoscopic examination, absolute and relative organ weights as well as macroscopical and histological examinations. Based on the results of the study and due to the absence of any toxicological relevant effect a subacute NOEL of 1000 mg/kg bw/day was derived for fatty acids, C16-18, 2-ethylhexyl esters.
Taken together, the available data on repeated dose toxicity from structural analogue substances do not indicate any adverse effects. Therefore, according to EU classification criteria, the target substance isopentyl oleate (CAS 627-89-4) is not to be classified.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to isopentyl oleate (CAS 627-89-4), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the analogue read-across approach, the available data on repeated dose toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for 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.
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