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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
OECD 404, GLP: not irritating
Eye Irritation:
OECD 405, GLP: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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
- 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
- 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.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
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 |
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
- Study period:
- 30 Mar - 04 Apr 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France- Weight at study initiation: 2.5 ± 0.2 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 drinking water (FG Millipore membrane (0.22 micron)), ad libitum- Acclimation period: at least 5 days ENVIRONMENTAL 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL - Amount(s) applied: 0.1 mL
- Observation period (in vivo):
- Reading time points: 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE - Washing: The eyes were not rinsed after administration of the test substance.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight conjunctivae redness and chemosis (score 1) were observed in 1/3 animals at the 1-h reading time point, which cleared within 24 h. Moderate conjunctivae and chemosis (score 2) were observed in 1/3 animals at the 1-h reading time point, which disappeared within 24 h. No effects on the iris and cornea were noted in any rabbit at any time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Table 1: Individual scores
Rabbit # | Time [h] | conjunctivae | iris | cornea | |
redness | swelling | ||||
1 | 1 | 0 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0,0 | 0,0 | 0,0 | 0,0 | |
2 | 1 | 2 | 2 | 0 | 0 |
24 | 0 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0,0 | 0,0 | 0,0 | 0,0 | |
3 | 1 | 1 | 1 | 0 | 0 |
24 | 0 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0,0 | 0,0 | 0,0 | 0,0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are data available regarding irritation/corrosion for methyl ricinoleate (CAS 141-24-2). In addition, read-across data from the appropriate substances methyl palmitate (CAS 112-39-0), fatty acids, rape-oil, me esters (CAS 85586-25-0), ethyl ricinoleate (CAS 55066-53-0), castor oil (CAS 8001-79-4) and fatty acids, C14-18 and C16-18-unsatd., me esters (CAS 67762-26-9) are taking into account as supporting information. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin Irritation
CAS 141-24-2
The skin irritation potential of the test substance was determined by an in vivo skin irritation test in rabbits performed according to OECD guideline 404 and in compliance with GLP (Arkema, 1999). A dose of 0.5 mL of the undiluted test substance was applied to the clipped skin of 3 male rabbits for 4 h, using a semiocclusive dressing. Skin reactions were assessed 1, 24, 48 and 72 h after exposure. Up to moderate erythema and edema were observed during the first 72 hours after exposure. The erythema scores (mean 24/48/72 h) were 1.33, 0.67 and 2.00 for each rabbit, respectively, and the erythema effects were reversible on Day 7, Day 4 and Day 6, respectively. The mean edema score (24/48/72 h) was 2.00 for one rabbit which was fully reversible on Day 6. For the other two rabbits no edema were observed. All edema were fully reversible within 21 days. The test substance methyl ricinoleate was considered not to be a skin irritant based on the results and under the conditions of this study.
Read across (CAS 85586-25-0)
The substance fatty acids, rape-oil, Me esters (CAS 85586-25-0) was tested for skin irritation potential on the shaved back skin of three rabbits (Kleinrussen, Chbb:HM) similar to OECD guideline 404 and according to GLP (Cognis, 1990). The contact time under semiocclusive conditions amounts to 4 h. The erythema score was 0 for animal 1. Erythema occurred with a score of 0.33 in animal 2 and with a score of 0.66 in animal 3. The reactions disappeared within 48 hours. The edema score was 0 for all animals. The source substance fatty acids, rape-oil, Me esters has proved to be not irritating on the skin.
Read across (CAS 112-39-0)
The undiluted read across substance Methyl Palmitate (CAS 112-39-0) was tested for skin irritation potential on the dorsal shaved skin of three rabbits (Kleinrussen, Chbb:HM) in a dose of 0.5 g according to OECD guideline 404 and GLP (BASF, 1992). The contact time under semiocclusive conditions lasted four hours. Up to moderate erythema and edema were observed during the first 72 hours after exposure. The erythema score (mean 24/48/72 h) was 1.67 for animal one and 3 for animal two and three. Erythema effects were reversible within 21 days for animal one and three and not reversible for animal 2. The mean edema score was 1 for animal 1, 2.67 for animal 2 and 2.33 for animal 3. All edema effects were fully reversible within 21 days. The source substance Methyl Palmitate proved to be irritating to skin according to the conditions applied.
Human data
Read across (CAS 55066-53-0)
The skin irritation potential of 20% ethyl ricinoleate in petrolatum was evaluated using 32 healthy male volunteers (ages not stated) in a 48-h closed patch test. Skin irritation was not observed (RIFM 2000).
Read across (CAS 112-39-0)
A 24 h Patch Test was performed with methyl palmitate (CAS 112-39-0) and was conducted according to COLIPA standard, which is in accordance with generally accepted scientific standards. Slight erythema was seen in 4/20 volunteers, 5 of them showed slight desquamation (mean score for erythema: 0.21; mean score for erythema, edema, desquamation and fissure: 0.47). The slight reactions occurring under 24 h occlusive test conditions indicate that the undiluted test substance methyl palmitate is not irritating to human skin (BASF, 1998).
Conclusion
Based on the available data with the target substance methyl ricinoleate (CAS 141-24-4) and in consideration of the available supporting data with the source substances, methyl ricinoleate (CAS 141-24-4) revealed no skin irritation potential.
Eye Irritation
CAS 141-24-2
The eye irritation potential of the test substance was determined by an in vivo eye irritation test in rabbits according to OECD guideline 405 and GLP (Arkema, 1999). A dose of 0.1 mL of the undiluted test substance methyl ricinoleate (CAS 141-24-2) was instilled into one eye of each of three male rabbits (Kleinrussen, Chbb:HM). Observations were made at 1, 24, 48 and 72 h after instillation. Slight conjunctivae and chemosis (score 1) were observed in 1/3 animals at the 1-h reading time point, which cleared within 24 h. Moderate conjunctivae and chemosis (score 2) were observed in 1/3 animals at the 1-h reading time point; which disappeared within 24 h. No effects on the iris and cornea were noted in any rabbit at any time point.
Read across (CAS 112-39-0)
In vivo
The undiluted test substance methyl palmitate (CAS 112-39-0) was tested for eye irritation (24 h contact) in rabbits (Kleinrussen, Chbb:HM) according to OECD TG 405 and GLP (BASF, 1992, in vivo). The single instillation dose amounted to 0.1 mL per conjunctival sac. The conjunctivae score (24/48/72h) was determined to be 0.33 for animal one and three. The effect was fully reversible within 48 h. The conjunctivae score for animal 2 was 0.66 and was reversible within 72 h. Cornea and iris effects were not observed.
In vitro
The intention of the HETCAM assay is to assess the acute irritation potential of a test substance to mucous membranes in analogy to the Draize Eye Irritation Test. For this purpose, a definitive dose of the test substance is applied to the corioallantoix membrane (CAM) of three fertilized and incubated hen´s eggs (BASF, 1992, in vitro). Undiluted methyl palmitate (CAS 112-39-0) was not irritating under the conditions of this study. According to this result the substance is considered as not eye irritating.
Read across (CAS 67762-26-9)
The substance fatty acids, C14-18 and C16-18-unsatd., Me esters (CAS 67762-26-9) was tested for primary eye irritation on rabbits by a single application of 0.1 mL of the undiluted test substance according to OECD TG 405 and GLP (BASF, 1988). The cornea, iris conjunctival scores were 0 for all animals, thus the test substance does not show eye irritant properties.
Human data
Read across (CAS 8001-79-4)
In a study by Secchi et al. (1990), a double-masked clinical trial was performed using a group of nine patients (ages not stated) with vernal keratoconjunctivitis. One eye was treated with 2% cyclosporine in castor oil four times daily for 15 days. The other eye was treated with castor oil solution only according to the same procedure. Mild and transient discomfort and minor epithelial changes were observed in both eyes.
Conclusion
Based on the available data with the target substance methyl ricinoleate (CAS 141-24-4) and in consideration of the available supporting data with the source substances, methyl ricinoleate (CAS 141-24-4) revealed no eye irritation potential.
Justification for classification or non-classification
The available target and source substance data on skin irritation and eye irritation/corrsoion 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.
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.