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EC number: 293-054-1 | CAS number: 91051-05-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- May 05th, 1992 - July 24th, 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). In accordance 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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Methyl linoleate
- EC Number:
- 203-993-0
- EC Name:
- Methyl linoleate
- Cas Number:
- 112-63-0
- IUPAC Name:
- methyl octadeca-9,12-dienoate
- Details on test material:
- - Name of test material (as cited in study report): Linolsäure-Methylester
- Chemical denomination: octadecadienoic acid methyl ester
- Batch No. 89F0928
- Physical state: colourless liquid
- Content of active substance. 99 %
- Purity: 100 %
- Stability: stable for at least one year, unstable in atmospheric oxygen, light and heat
- Stability after taking a sample: one hour
- Storage: cool and dark
- Expiration date: April 1993
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany.
- Age at study initiation: approx 6 weeks
- Weight at study initiation: approx. 340 g
- Housing: 2-3 animals in Makrolon Type IV cages with standard softwood bedding
- Diet (ad libitum): Altromin Maintenance Diet 3022, Lage, Germany.
- Water (ad libitum): community tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Remarks:
- DAB 9, batch 2933
- Concentration / amount:
- Induction: 40%
Challenge: 20 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Remarks:
- DAB 9, batch 2933
- Concentration / amount:
- Induction: 40%
Challenge: 20 %
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
In preliminary studies with 3 guinea pigs 40% dilution of the test substance was found to be the minimally irritating concentration and 20 % dilution was found to be the maximally non-irritating concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h under occlusive conditions using a patch test chamber (van der Bend, INTERDERM bv)
- Test groups: 10 animals were treated with 0.08 mL TS per chamber
- Control group: 20 animals, vehicle only
- Site: left cranial sheared flank
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 40 %
The results of the 3rd induction was evaluated 1 and 24 hours after the end of exposure.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction
- Exposure period: 6 h under occlusive conditions
- Test groups: 10 animals, TS
- Control group: 10 animals, TS; additionally, a second control group of 10 animals was treated with olive oil alone in the first and second week after the challenge of the other groups in order to estimate the influence of the vehicle.
- Site: bilaterally to sheared caudal flanks
- Concentrations: 20 %
- Evaluation (hr after challenge): 24 and 48 h
Results and discussion
- Positive control results:
- A reliability check had been performed in May 1990 (TBD 900384)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st reading from the right flank
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 1st reading from the right flank. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 1st reading from the left caudal flank
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 1st reading from the left caudal flank. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 1st reading from the right flank
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 1st reading from the right flank. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 1st reading from the left caudal flank
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 1st reading from the left caudal flank. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 2nd reading from the right flank
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 2nd reading from the right flank. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 2nd reading from the left caudal flank
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 2nd reading from the left caudal flank. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 2nd reading from the right flank
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 2nd reading from the right flank. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: 2nd reading from the left caudal flank
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: 2nd reading from the left caudal flank. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: reading from the left caudal flank
- Hours after challenge:
- 168
- Group:
- other: vehicle control group
- Dose level:
- 0 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: reading from the left caudal flank. . Hours after challenge: 168.0. Group: other: vehicle control group. Dose level: 0 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
- Reading:
- other: reading from the right flank
- Hours after challenge:
- 168
- Group:
- other: vehicle control group
- Dose level:
- 0 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: other: reading from the right flank. . Hours after challenge: 168.0. Group: other: vehicle control group. Dose level: 0 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Any other information on results incl. tables
All test animals and negative control animals were without any distinct dermal effects after challenge.
No deaths occurred and no significant differences in the gain of the body weight occurred.
All tested animals, negative control animals and additional animals receiving only treatment with olive oil (vehicle control group) showed weak to moderate dermal reactions. Thus, the test substance itself was proven to be a non-sensitizer on the skin of guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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