Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 205-472-3 | CAS number: 141-24-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 - 31 Mar 1999
- Reliability:
- 1 (reliable without restriction)
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France - Weight at study initiation: 2.3 ± 0.1 kg - Housing: The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle. - Diet: 112 C pelleted diet (UAR, 91360 Villemoisson sur-Orge, France), ad libitum - Water: filtered (FG Millipore membrane (0.22 micron)) drinking water, ad libitum - Acclimation period: at least 5 days before the beginning of the studyENVIRONMENTAL CONDITIONS - Temperature (°C): 18 ± 3 - Humidity (%): 30 to 70 - Air changes (per hr): approximately 12; filtered, non-recycled air - Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL - Amount(s) applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE - Type of wrap if used: The test substance and the dry gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semiocclusive dressing and a restraining bandage. OBSERVATION TIME POINTS1, 24, 48 and 72 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Animal #1 showed an erythema grade of 2 at the 24-h reading time point and an erythema score of 1 at the 48-h reading time point, which persisted up to Day 6. A well-defined edema was observed up to the 72-h reading time point, which was fully reversible on Day 5. Animal #2 showed very slight erythema at the 24-h and 48-h reading time point. Animal #3 showed well-defined erythema from the 24-h reading time point, which persisted up to the 72-h reading time point, and a slight erythema on Day 5, which was fully reversible on Day 6.In animal #2 and #3 no edema were noted at the 24-h, 48-h and 72-h reading time point. Dryness of the skin was recorded in animal # 1 on day 6 and in animal # 3 from Day 4 - 8.Mean scores over 24, 48 and 72 hours for each animal were 1.3, 0.7 and 2.0 for erythema and 2.0, 0.0 and 0.0 for edema.
Any other information on results incl. tables
Table: Results of skin irritation study
| Observation time | Rabbit no. | |||||
| 1 | 2 | 3 | ||||
| Erythema | Edema | Erythema | Edema | Erythema | Edema | |
| 1 h | 2 | 2 | 2 | 2 | 2 | 2 |
| 24 h | 2 | 2 | 1 | 0 | 2 | 0 |
| 48 h | 1 | 2 | 1 | 0 | 2 | 0 |
| 72 h | 1 | 2 | 0 | 0 | 2 | 0 |
| Mean value 24 + 48 + 72 h | 1,33 | 2,00 | 0,67 | 0,00 | 2,00 | 0,00 |
| Day 5 | 1 | 0 | 0 | 0 | 1 | 0 |
| Day 6 | 1 | 0 | 0 | 0 | 0 | 0 |
| Day 7 | 0 | 0 | 0 | 0 | 0 | 0 |
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
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.
