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EC number: 270-616-4 | CAS number: 68459-67-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- no information on test substance purity
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test was performed as laid down in the F.D.A. Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p. 47.
- Principle of test: A 0.5 mL sample of the test material was applied to clipped areas of both intact and abraded skin of four New Zealand White rabbits under occlusive conditions for 24 h.
- Parameters analysed / observed: Skin reaction according to Draize scale was measured immediately and 48 h after patch removal. - GLP compliance:
- no
Test material
- Reference substance name:
- Castor oil, ester with glycerol
- EC Number:
- 270-616-4
- EC Name:
- Castor oil, ester with glycerol
- Cas Number:
- 68459-67-6
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Castor oil, ester with glycerol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- One side of each back was additionally abraded with a suitable abrading tool, the other back side was left intact.
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after patch removal
Reading time points: 0 and 48 h after patch removal - Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: animals back
- Type of wrap if used: One inch gauze pads were secured with adhesive tape and further occluded with a stockinette sleeve covering the entire trunk of the animal.
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #3
- Remarks:
- intact skin side
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- intact skin side
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- intact skin side
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 4 animals; intact skin sides
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 4 animals; intact skin sides
- Time point:
- other: 0 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- On intact skin, slight to well defined erythema (grade 1-2) was apparent in three rabbits immediately after patch removal. This irritation was reversible within 48 h after patch removal. No edema was observed in any animal at any reading time point.
Any other information on results incl. tables
Table 1. Results of skin irritation test on intact and abraided skin.
Observation time |
Intact skin |
|||||||
Rabbit no. |
||||||||
1 |
2 |
3 |
4 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
0 h |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abraded skin |
|||||||
0 h |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
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:
- Under the conditions of this skin irritation study in rabbits the undiluted test substance was not irritating to the skin.
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