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EC number: 205-472-3 | CAS number: 141-24-2
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Mar -19 Apr 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA guideline study was not validated at the time the guinea pig maximisation test was performed (1999).
Test material
- Reference substance name:
- Methyl ricinoleate
- EC Number:
- 205-472-3
- EC Name:
- Methyl ricinoleate
- Cas Number:
- 141-24-2
- Molecular formula:
- C19H36O3
- IUPAC Name:
- methyl ricinoleate
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France- Females nulliparous and non-pregnant: yes- Age at study initiation: approximately 3 months - Weight at study initiation: 382 ± 14 g (males); 357 ± 10 g (females)- Housing: The animals were housed individually in polycarbonate cages (48 cm x 27 cm x 20 cm) equipped with a polypropylene bottle. Dust-free sawdust was provided as litter (SICSA, 92142 Alfortville, France).- Diet: 106 pelleted diet (UAR, 91360 Villemoisson sur-Orge, France), ad libitum- Water: filtered drinking water (FG Millipore membrane (0.22 micron)), ad libitum- Acclimation period: at Ieast 5 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 21 ± 2- Humidity (%): 30 - 70- Air changes (per hr): approximately 12 - Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- 24 h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 5 males and 5 females (controls), 10 males and 10 females (treated)
- Details on study design:
- MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 2 (intradermal and epicutaneous, respectively) - Exposure period: single injection (intradermal) and 48 h (epicutaneous) - Test groups: On day 1, intradermal injections of Freund's complete adjuvant mixed with the test substance at a concentration of 10% (w/w) in corn oil (treated group) or the vehicle (control group) were performed in the interscapular region.On day 7, the same region received a topical application of sodium lauryl sulfate in vaseline (10%, w/w) in order to induce local irritation.On day 8, the undiluted test substance (treated group) or the vehicle (control group) was applied to the same test site which was then covered by an occlusive dressing for 48 hours. B. CHALLENGE EXPOSUREOn day 22, after a rest period of 12 days, all animals of the treated and control groups were challenged by a cutaneous application of the undiluted test substance to the right flank. The left flank served as control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 hours.Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing. At the end of the study, animals were killed without examination of internal organs. No skin samples were taken from the challenge application sites.The sensitivity of the guinea pigs in CIT experimental conditions was checked with a positive sensitizer, 2,4-Dinitro Chlorobenzene (DNCB). During the induction period, the reference substance DNCB was applied at the concentrations of 0.1% (w/w) (day 1) and 1% (w/w) (day 8) in corn oil. For the challenge application, the reference substance DNCB was applied at the concentration of 1% (w/w) in corn oil.
- Challenge controls:
- Challenge (all groups)topical application: RICINOLEATE DE METHYLE undiluted.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitro chlorobenzene (DNCB)
Results and discussion
- Positive control results:
- The species and strain which were used showed a satisfactory sensitization response in 90% animals treated with DNCB.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 25 and 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema observed in 1/10 controls and 5/20 treated animals
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 25 and 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Table 1: Scores of the control group
Animal number | 24 h | 48 h | |||||||
Erythema | Oedema | Erythema | Oedema | ||||||
Left flank | Right Flank | Left flank | Right Flank | Left flank | Right Flank | Left flank | Right Flank | ||
Male | 31 | 0 | 0 | 0 | 0 | 0 / S | 0 / S | 0 | 0 |
32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
33 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
34 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
35 | 0 | 0 | 0 | 0 | 0 / S | 0 / S | 0 | 0 | |
Female | 46 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 |
47 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
49 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
50 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 |
S: Dryness of skin
Table 2: Scores of the treatment group
Animal number | 24 h | 48 h | |||||||
Erythema | Oedema | Erythema | Oedema | ||||||
Left flank | Right Flank | Left flank | Right Flank | Left flank | Right Flank | Left flank | Right Flank | ||
Male | 36 | 0 | 1 | 0 | 0 | 0 | 0 / S | 0 | 0 |
37 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
38 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
39 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
41 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
42 | 0 | 1 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
43 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
44 | 0 | 0 | 0 | 0 | 0 / S | 0 / S | 0 | 0 | |
45 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Female | 51 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 |
52 | 0 | 1 | 0 | 0 | 0 | 0 / S | 0 | 0 | |
53 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
54 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
55 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
56 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
57 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 | 0 | |
58 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
59 | 0 | 1 | 0 | 0 | 0 / S | 0 / S | 0 | 0 | |
60 | 0 | 0 | 0 | 0 | 0 | 0 / S | 0 | 0 |
S: Dryness of skin
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
- Executive summary:
The sensitization potential of the test substance was evaluated in the guinea pig according to the maximization procedure by Magnusson and Kligman. 20 Dunkin-Hartley guinea pigs (10 males and 10 females) were treated in the test group. The test substance was applied by intradermal injection at a concentration of 25% in corn oil, after 7 days, the animals were induced (and irritation by sodium lauryl sulfate in vaseline) epicutanously by the undiluted test item. On day 22, after a period of 12 days, treated animals and controls were challenged by a cutaneous application of the test substance to the right flank. The left flank served as control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 h.
Skin reactions were evaluated approximately 24 and 48 h after removal of the dressing.
No symptoms, mortality or cutaneous reactions due to any sensitization process by treatment with the test substance were observed in guinea pigs.
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