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EC number: 941-981-3 | CAS number: -
- 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
Skin irritation: Based on read-across from a structural analogue, Fatty acids, C18 unsaturated, ethyl & methyl esters has no skin irritating potential.
Eye irritation: No eye irritating potential.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 07 Apr - 29 Apr 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study, tested with the source substance Methyl linoleate (CAS No. 112-63-0). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen, CHbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 15 months
- Weight at study initiation: approx. 2600 g
- Housing: individual accommodation
- Diet (e.g. ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, Soest/D, Batch: 770392/02, 550492/O9) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h; the observation period lasted 22 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal shaved skin, 6cm²
- Type of wrap if used: adhesive air- and vapour permeable gauze-patch which was fixed by a hypoallergenic adhesive gauze-bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the relevant skin was cleaned from the residual test substance
- Time after start of exposure: 4h
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The irritation effects of one experimental animal reversed within 7 days. The skin of this rabbit showed eschar. The observed effects of the other two experimental animals reversed completely within 22 days.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
(DSD: Xi, R38: Irritating to skin)
Reference
Table 1: Individual irritation scores
Skin effect |
Erythema |
Edema |
||||||||
Scoring |
Scores at |
Mean |
Scores at |
Mean |
||||||
Animal No. |
1h |
24h |
48h |
72h |
24-72h |
1h |
24h |
48h |
72h |
|
1266/1 |
1 |
2 |
2 |
2 |
2.00 |
0 |
2 |
1 |
1 |
1.33 |
1297/1 |
1 |
2 |
3 |
3 |
2.67 |
0 |
1 |
2 |
3 |
2.00 |
1300/1 |
1 |
1 |
1 |
1 |
1.00 |
1 |
1 |
2 |
1 |
1.33 |
Linolsäure Methylester has not to be classified according to CLP. According to DSD it has to be classified as:
Xi, R38: Irritating to skin
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (purity: 80%)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Sevices (no further details)
- Age at study initiation: 11 weeks
- Weight at study initiation: 1956 - 2168 g
- Housing: individually housed in suspended stainless steel caging
- Diet: Harlan Teklad Global High Fiber Rabbit Diet #2031, a designated amount of the diet (approximately 150 g/day) and a Premium Timothy Cube (Ontario Dehy Inc.) were available to each rabbit
- Water: filtered tap water, ad lbitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 53 - 56
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Prior to instillation, 1 - 2 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%) were placed into both the treated and control eye of each animal. - Duration of treatment / exposure:
- single instillation (no washing)
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: wight light source, fluorescein dye evaluation in the treated eye 24 h after administration - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritant / corrosive response data:
- No local, occular effects indicative for eye irritation have been observed in any test animal at any reading time point.
- Other effects:
- All animals appeared active and healthy and gained body weight during the study. There was no ocular irritation or other signs of gross toxicity, adverse clinical effects, or abnormal behavior.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Irritation
Justification for read-across
No data on skin irritation are available for Fatty acids, C18 unsaturated, ethyl & methyl esters whereas data regarding eye irritation are available for Fatty acids, C18 unsaturated, ethyl & methyl esters. In order to fulfil the standard data requirements regarding skin irritation defined in Regulation (EC) No 1907/2006, Annex VIII, 8.1, read-across to a structural analogue substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
According to 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) “to avoid the need to test every substance for every endpoint”.
Fatty acids, C18 unsaturated, ethyl & methyl esters is a multi-constituent substance specified by esters of ethanol and methanol with fatty acids C18 unsaturated (source canola oil) resulting in monoesters which meets the definition of an UVCB substance. Thus, the test substance represents fatty acid esters which undergo to a high extent hydrolysis by ubiquitous expressed gastrointestinal enzymes into the free fatty acid components and the respective alcohol moieties (Lehninger, 1970; Mattson and Volpenhein, 1972). Considering the common metabolism, the read-across approach is based on the presence of a common functional group, common precursors and the likelihood of common breakdown products via biological processes, which result in structurally similar chemicals with similar physico-chemical, toxicological and toxicokinetic behaviour. For further details on the read-across approach, please refer to the analogue justification in section 13 of the technical dossier.
As no data on skin irritation are available for Fatty acids, C18 unsaturated, ethyl & methyl esters, read-across to reliable data on the analogue substance Methyl linoleate (CAS 112-63-0) was conducted. Methyl linoleate (CAS 112-63-0) is a component of Fatty acids, C18 unsaturated, ethyl & methyl esters and is therefore regarded as a suitable analogue substance.
Skin Irritation
CAS 112-63-0
A primary dermal irritation study was performed with methyl linoleate (CAS 112-63-0) according to OECD Guideline 404 (Pittermann, 1992). The shaved dorsal skin of three Kleinrussen rabbits was exposed to 0.5 mL unchanged test material for 4 hours under semi-occlusive conditions. The rabbits were observed for 22 days. Skin reactions were assessed using the Draize scheme 1, 24, 48, 72 hours after removal of the test substance. After an exposure period of 4 hours slight to moderate erythema and edema were observed in all three animals. All irritation effects were fully reversible within 7 - 22 days following patch removal.
Eye irritation
An acute eye irritation study with EC 941-981-3 (purity: 80%) was performed according to OECD Guideline 405 with 3 female New Zealand albino rabbits (Slonina, 2015). One eye of the rabbits was exposed to 0.1 mL of the undiluted test substance and scored for eye reactions. The animals were observed for 72 h and scoring was performed 1, 24, 48 and 72 h after application. There was no conjunctival redness and no effects on conjunctival swelling, iris, or cornea observed at any reading time point.
Conclusion on skin and eye irritation properties
Skin and eye irritation properties have been investigated in vivo indicating no irritating properties of neither the target nor the analogue substance towards the skin or eyes. Therefore, based on these data, Fatty acids, C18 unsaturated, ethyl & methyl esters is not considered as skin or eye irritant.
A detailed reference list can be found in the CSR and in section 13 of the dossier.
Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from a
structural analogue. The selected study is adequate and reliable based
on the identified similarities in structure and intrinsic properties
between source and target substance and overall quality assessment
(refer to the endpoint discussion for further details).
Justification for selection of eye irritation endpoint:
The reliable GLP compliant OECD Guideline study was taken.
Justification for classification or non-classification
Based on available substance and analogue read-across data, the available data on skin and eye irritation 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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