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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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for grouping of substances and read-across
There are only limited data available on skin sensitisation of isopentyl oleate (CAS 627-89-4). In order to fulfil the standard information requirements set out in Annex VII, 8.3., 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 skin sensitisation
CAS
Chemical name
Molecular weight [g/mol]
Skin sensitisation
627-89-4 (a)
Isopentyl oleate
326.56 - 354.61
WoE:
RA: CAS 163961-32-8
RA: CAS 91031-48-0
163961-32-8 (b)
Fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters
312.53-340.58
Experimental result:
not sensitising
91031-48-0 (b)
Fatty acids, C16-18, 2-ethylhexyl esters
368.65 - 396.7
Experimental result:
not sensitising
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font.
The above mentioned substances are 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 skin sensitisation is available with isopentyl oleate (CAS 627-89-4). Therefore, read across from the structurally analogue substances fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters (CAS 163961-32-8) and fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) was applied.
Skin sensitisation
CAS 163961-32-8
The skin sensitising properties of fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters (CAS 163961-32-8) were tested in a study according to OECD TG 406 under GLP conditions using the Guinea pig maximization test (GPMT, Sanders, 2002c). The GPMT test was performed on 10 male Dunkin-Hartley guinea pigs. For the intradermal and epicutaneous inductions the initial test item concentration was 1% (v/v in arachis oil) and 100%, respectively, whereas a 50% and 75 % (v/v in arachis oil) formulation of the test item was selected for the challenge exposure. At the beginning of the induction exposure 10 test animals and 5 control animals were either intradermally treated with 1% of the test substance or vehicle (Day 0), followed by a topical induction (100% or vehicle) under occlusive conditions one week later. On Day 22 all animals were challenged with the test substance at a concentration of 50% and 75%. Skin reactions of all animals were evaluated 24 and 48 hours after challenge exposure (after removal of the patch). A transient challenge reaction (slight erythema, grade 1) was observed in 1/10 animals of the test group at the 24 h reading time point (75% test substance), only, with desquamation evident at the 48 h reading time point. Furthermore no skin reactions were observed in the negative controls (5 animals). Periodic reliability checks had been performed 2 times a year with 10 test and 5 control animals using alpha-hexylcinnamaldehyde and 2-mercaptobenzothiazole as positive control substances confirming the sensititvity of the used animal strain. Thus, under the conditions of the test, the test substance revealed no skin sensitising properties.
CAS 91031-48-0
The skin sensitising properties of fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) were tested in a study according to OECD TG 406 under GLP conditions using the Guinea pig maximization test (GPMT, Clouzeau, 1991). The GPMT test was performed on 20 Dunkin-Hartley guinea pigs (10 males and 10 females). For the intradermal and epicutaneous inductions the initial test item concentration was 25% (v/v paraffin oil) and 100%, respectively whereas a 50% (v/v in paraffin oil) formulation of the test item was selected for the challenge exposure. At the beginning of the induction exposure 20 test animals and 10 control animals (5 males and 5 females) were either intradermally treated with 25% of the test substance or vehicle (Day 0), followed by a topical induction (100% or vehicle) under occlusive conditions one week later. On Day 20 all animals were challenged with the test substance at a concentration of 50%. Skin reactions of all animals were evaluated 24 and 48 hours after challenge administration and did not reveal any indication for a skin sensitising potential of the test material. Furthermore no skin reactions were observed in the negative controls. No information on periodic reliability checks with positive control substances is available. In conclusion, under the conditions of the test, the test substance revealed no skin sensitising properties.
Taken together, the available data on skin sensitisation from structural analogue substances do not indicate any sensitising potential. Therefore, according to EU classification criteria, the target substance isopentyl oleate (CAS 627-89-4) is not to be classified.
Migrated from Short description of key information:
Skin sensitisation (WoE, OECD 406), guinea pig: not sensitising (RA CAS 163961-32-8 and RA CAS 91031-48-0)
Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 skin sensitisation 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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