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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 MARCH-31 MARCH 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)
- GLP compliance:
- yes (incl. QA statement)
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:
- Animals
Sex, species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study. Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animais: three animais were used, as recommended by the international guidelines. Identification: the animais were identified individually with a metal ear tag.
Weight: on the day of treatment, the animais had a mean body weight ± standard deviation of 2.3 ± 0.1 kg.
Acclimatization: at least 5 days before the beginning of the study.
Environmental conditions
The conditions in the animal room were set as follows:
.temperature: 18 ± 3°C
.relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
.ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animais 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.
Food and water
During the study, the animais had free access to 112 C pelleted diet (UAR, 91360 Villemoisson sur-Orge, France).
Each batch of food was analysed by the supplier for composition and contaminant levels. The diet formula is presented in appendix 2.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by extemal laboratories.
The results of these analyses are archived at CIT.
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- The test substance was used undiluted.
A single dose of 0.5 ml of the test substance was placed on a dry gauze pad, which was then applied to the right flank of the animals for 4 hours. - Duration of treatment / exposure:
- 4 HOURS
- Observation period:
- The skin was examined approximately l hour, 24, 48 and 72 hours after removal of the dressing.
- Number of animals:
- 3
- Details on study design:
- The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
The untreated skin served as control.
The skin was examined approximately l hour, 24, 48 and 72 hours after removal of the dressing. FollowingtheOECDandECguidelines:
Following the OECD and EC guidelines:
. when there was no evidence of dermal irritation after 72 hours, the study was ended.
. when there was persistent cutaneous irritation after 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversi bili ty.
. when severe irritant effects were observed, the animais were killed on humane grounds. Any change in the animais' behaviou r was noted
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Table1:Individualcutaneousexaminationsandmeanvaluesofthescoresrecordedateachreading(24,48and72hours)foreachanimal
Rabbitnumber |
DermalIrritation |
|
|
Scores |
|
Mean irritation |
Interpretation (+) |
|
|
lhDl |
24h 02 |
48h 03 |
72h 04 |
score(1) |
(-) |
716 |
Erythema |
2 |
2 |
|
|
1.3 |
(-) |
|
Oedema |
2 |
2 |
2 |
2 |
2.0 |
(+) |
Other |
* |
* |
* |
* |
|
||
717 |
Erythema |
2 |
|
|
0 |
0.7 |
(-) |
|
Oedema |
2 |
0 |
0 |
0 |
0.0 |
(-) |
Other |
* |
* |
* |
* |
|
||
718 |
Erythema |
2 |
2 |
2 |
2 |
2.0 |
(+) |
|
Oedema |
2 |
0 |
0 |
0 |
0.0 |
(-) |
Other * * * s
(l)meanofscoresondays2,3and4h -hour
D -day
(+)-irritantaccordingtoE.E.C.criteria
(-)-non-irritantaccordingtoE.E.C.criteria
* -None
S-Drynessoftheskin
Table1(continued)
Rabbit
Dermal
Scores
number
Irritation
|
D5 |
06 |
D7 |
D8 |
D9 |
|
716 |
Erythema |
|
|
0 |
|
|
|
OedemaOther |
0 • |
0
s |
0 • |
|
|
717 |
Erythema |
|
|
|
|
|
|
Oedema |
|
|
|
|
|
|
Other |
|
|
|
|
|
718 |
Erythema |
|
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
|
Other |
s |
s |
s |
s |
• |
D -day
• -None
s-Drynessoftheskin
-Cutaneousexaminationnot performed
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Executive summary:
The studydesign was established accordingto available information on the test substance and the above OCDE 404 guideline.
The test substance was applied for 4hours to three male New Zealand White rabbits.
A single dose of 0.5 ml of the undiluted testsubstance was applied to the closely-clippeds kin of one flank.
The test substance was held in contact with the skin by means of as emi-occlusive dressing. Cutaneous reactions were observed approximately1hour,24,48 and72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions.
The mean values of the scores for erythema and oedema were calculated for each animal.
Results
A very slight or well-defined erythema was noted in all animals from day1 up to day3 ,5 or 6 . A slight oedema was observed in all animals on day 2, it persisted up to day 4 in one of them.
Dryness of the skin was recorded in one animal on day 6and in another one between days 4 and 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 oedema.
Conclusion
Under our experimental conditions, the test substance RICINOLEATE DEMETHYLE (batchNo.9802001) is irritant when applied topically to rabbits.
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