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Diss Factsheets
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EC number: 948-027-5 | CAS number: -
- 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
- Remarks:
- skin irritation/corrosion in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 December 1999-4 January 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Likely performed under GLP but not sufficiently documented
- Justification for type of information:
- Guideline method conducted in a reliable laboratory but without sufficient GLP documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Dept. of Transporation (DOT) 49 CFR 173.136-7, 1994
- Principles of method if other than guideline:
- Occlusive exposure of rabbits to test material for 3 m, 60 m or 4 h.
- GLP compliance:
- yes
- Remarks:
- signature of QA officer but no statement available.
Test material
- Reference substance name:
- 3-hydroxy-2,2-bis(hydroxymethyl)propyl (R)-12-hydroxyoleate
- EC Number:
- 201-095-3
- EC Name:
- 3-hydroxy-2,2-bis(hydroxymethyl)propyl (R)-12-hydroxyoleate
- Cas Number:
- 78-22-8
- Molecular formula:
- C23H44O6
- IUPAC Name:
- 3-hydroxy-2,2-bis(hydroxymethyl)propyl 12-hydroxyoctadec-9-enoate
- Reference substance name:
- Castor oil
- EC Number:
- 232-293-8
- EC Name:
- Castor oil
- Cas Number:
- 8001-79-4
- Test material form:
- liquid
- Details on test material:
- Contains an additive (identifier redacted, CBI) having the following characteristics: Skin Corr Category 1C, Eye Damage Category 1
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm
- Age at study initiation:
- Weight at study initiation:
- Housing:singly in suspended stainless steel cages with mesh floors.
- Diet (e.g. ad libitum): ad libitum, Purina Rabbit Chow 5326
- Water (e.g. ad libitum): ad libitum, municiple tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: December 1999 To: January 21, 2000
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- Oster A5-small
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 0-3 minutes, from 3 - 60 minutes, from 60 minutes to 4 hours.
- Observation period:
- 1 h after patch removal. For the 4 hour time point, subsequent evaluations were performed approximately 24, 48 and 72 h after removal of the 4 h patch.
- Number of animals:
- 3 per time point
- Details on study design:
- The dorsal area of each rabbit's trunk was clipped free of fur; each was examined for evidence of pre-test skin irritation. Three test sites, each approximately 6 cm2, were delineated on each rabbit. Five-tenths of a ml of the test stubstance was applied to each of the sites on each animal and covered with a 1 in x 1 in 4-ply gauze pad. The torso of each was wrapped with 3-in Micropore tape and Elizabethan collars were placed on each rabbit and they were returned to their cages. The collars were removed after 4 h.
The patches were removed at the appropriate intervals (3 minutes, 1 hour and 4 hours). The sites were gently wiped with water and a clean towel to remove any residual test substance. All sites were evaluated for corrosion 1 h after patch removal. Subsequent evaluations were performed approximately 24, 48 and 72 h after removal of the 4 h patch.
Corrosion was considered to have resulted if the test substance caused full-thickness necrosis (or ulceration) at the test site in at least 1 animal. Full-thickness necrosis is defined as moderate to severe tissue destruction with well-defined dark brown or black discoloration and/or stiffened texture, covering a substantial area. Epidermal sloughing, erythema edema or fissuring were not considered tissue destruction. The test sites were also evaluated for skin irritation according to the Draize score system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: corrosion
- Basis:
- mean
- Time point:
- other: 3 minutes, 60 minutes, 4 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: not corrosive
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 10 d
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 10 d
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No sign of dermal corrosion was noted at any of the treated sites. The test substance is considered non-corrosive as applied.
Some irritation was noted in all animals, persisting through day 10. By day 14, the irritation was reversed. The conclusion is moderate irritation. - Other effects:
- 3-minute exposure: One hour after patch removal, very slight edema and/or erythema were observed in 2 of 3 animals. By the 24-h evaluation mark, very slight and/or very slight to well-defined erythema were noted at all 3 sites. The incidence and severity decreased with time and cleared by day 7. Desquamation was evident in one animal between days 7-10, when the site cleared.
1-hour exposure: One hour after patch removal, very slight edema and/or erythema were observed in all 3 animals. By the 24-h evaluation mark, very slight to well-defined edema and erythema were noted at all 3 sites. The incidence and severity decreased with time and cleared by day 7. Desquamation was evident in one animal between days 7-10, when the site cleared.
4-hour exposure: One hour after patch removal, very slight edema and/or erythema were observed in all 3 animals. By the 24-h evaluation mark, very slight to well-defined edema and well-defined erythema were noted at all 3 sites. The incidence and severity decreased with time and desquamation was evident in one animal between days 7-14, when the site cleared.
The highest value for erythema and edema were observed in the group having the 4 hour exposure, where the PDII was 3.7 of 8, considered by the study directors to be moderately irritating.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The skin corrosion and irritation potential of the test substance was examined in rabbits in a guideline skin corrosion study in rabbits. The neat substance is not corrosive to the skin at exposure times up to 4 hours. A 4-hour exposure was found to be moderately irritating to the skin, likely due to the contribution of an additive known to cause skin corrosion (Category 1C) and severe eye damage (Category 1) These effects resolved within 10-14 days after exposure.
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