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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Skin irritation / corrosion
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl linoleate
- EC Number:
- 203-993-0
- EC Name:
- Methyl linoleate
- Cas Number:
- 112-63-0
- Molecular formula:
- C19H34O2
- IUPAC Name:
- methyl octadeca-9,12-dienoate
Constituent 1
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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)
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.