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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
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion (no guideline followed): not irritating
Eye irritation (OECD 405): 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:
- 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
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- 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 - 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.
- 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.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 02 - 05 Dec 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The basic method followed that described in the Federal Register 1973, Volume 38, No. 187, 1500. 41, with minor modifications.
- Principle of test: The undiluted test substance was applied on abraded and intact clipped skin sides of 6 rabbits for 24 h under occlusive conditions. Erythema and edema was scored according to Draize scoring system immediately and 48 h after patch removal. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Nr. Loughborough, Leicestershire, England
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet (John Waring (Feeds) limited, Shardlow, Derbyshire, England), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Air changes (per hr): at least 20
- Photoperiod (hrs dark / hrs light): 10/14
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- The right side of each rabbit was abraded using an abrading tool and the left side was left intact.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h
Reading time points: 0 and 48 h after patch removal - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 30 mm circle on the dorsal/flank area: right side: clipped and abraded; left side: clipped and intact
- Type of wrap if used: composite patch consisted of a 30 mm circle of absorbent lint S.P.C. backed by a 50 mm circle of polythene with a final backing of a 50 mm diameter of lint. The patch was held securely over the test sites by two lengths of sleek adhesive strapping in the form of a cross. A "rabbit corset" and "toby collar" were then applied to prevent the animals from interferrinq with the dressings.
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 6 animals (intact skin side)
- Time point:
- other: 0/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 6 animals (intact skin side)
- Time point:
- other: 0/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test substance produced no evidence of erythema or edema in any of the test animals.
- 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 the Primary Skin Irritation Test in rabbits the test substance does not possess any skin irritating potential.
Referenceopen allclose all
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 |
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no information on purity of test substance given; limited documentation; scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- yes
- Remarks:
- limited documentation; scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Qualifier:
- according to guideline
- Guideline:
- other: F.D.A. Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p. 47.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing, 2 and 4 sec
- Observation period (in vivo):
- 7 days
Reading time points: 1, 2, 3, 4 and 7 days - Number of animals or in vitro replicates:
- 3 per group (no washing, 2 and 4 sec exposure)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes where washed with 20 mL lukewarm water.
- Time after start of exposure: 2 or 4 sec
SCORING SYSTEM: Draize scoring system; scoring of conjunctivae as redness, chemosis and discharge was given in combined score only (Scores of Redness + Chemosis + Discharge) x 2 = 20 (Maximum score)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- chemosis score
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The test substance produced mild conjunctival irritation (total conjunctivae score 4 and 6) 24 h after instillation without washing in all 3 rabbits. This conjunctival irritation was reversible within 48 h.
In rabbits in which the treated eyes were washed after 2 or 4 sec no irritation was observed at any observation time point. - 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 eye irritation study in rabbits the test substance was not irritating to the eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 01 - 04 Dec 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no information on purity of test substance given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- yes
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics., England
- Weight at study initiation: approx. 2.5 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet, J. Waring (Feeds) Limited, Shardlow, Derbyshire, England; ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Air changes (per hr):at least 20
- Photoperiod (hrs dark / hrs light): 10/14 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- No evidence of ocular irritation was seen in any of the test animals throughout the observation period.
- 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 eye irritation study in rabbits the test substance was not irritating to the eye.
Referenceopen allclose all
Table 1: Results of Draize test in unwashed eye
Alteration |
Animal No. |
Time (h) |
||||
24 |
48 |
72 |
mean 24/48/72 h |
reversible within |
||
Cornea |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae Redness + Chemosis + Discharge * |
1 |
4 |
0 |
0 |
0 |
0 |
2 |
4 |
0 |
0 |
0 |
0 |
|
3 |
6 |
0 |
0 |
0 |
0 |
* Combined scores only; (Scores of redness + chemosis + discharge) x 2 = 20 (maximum score)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential of the test substance was determined by an in vivo skin irritation test (WoE, 1972) in albino rabbits. 0.5 mL of the test substance was applied to the clipped skin (abraded and non-abraded skin sites) of four rabbits under occlusive conditions for 24 hours. After the exposure period the patch was removed and scores were taken immediately and 48 hours after patch removal using the Draize scoring system. On intact skin, slight to well defined erythema (grade 1-2) was apparent in three rabbits directly after patch removal, and they were reversible within 48 h. No edema was observed in any animal at any reading time point. Based on the results, the undiluted test substance was not irritating to the skin under the conditions of the test.
The skin irritation potential of the test substance was determined by an in vivo skin irritation test (WoE, 1980) in albino rabbits. 0.5 mL of the test substance was applied to the clipped skin (abraded and non-abraded skin sites) of four rabbits under occlusive conditions for 24 hours. After the exposure period the patch was removed and scores were taken immediately and 48 hours after patch removal using the Draize scoring system. All skin areas, treated with the undiluted or with one of the three solutions of the test substances, did not show any alterations at any observation time point. Based on the results, the undiluted test substance was not irritating to the skin under the conditions of the test.
Conclusion:
Based on all available information on skin irritation toxicity from a weight-of-evidence approach, the target substance Castor oil, ester with glycerol (CAS 68459-67-6) was not irritating to the skin.
Eye irritation
The eye irritation potential of the test substance was investigated in six albino rabbits according to a protocol similar to OECD Guideline 405 (WoE, 1980). 0.1 mL of the test material was placed in the right eye of each animal. The left eye remained untreated and served as control. The eyes were examined and scored according to Draize 24, 48 and 72 hours after application. Cornea, conjunctivae and iris were not affected by the test substance. The overall mean scores after 24, 48 and 72 hours out of six rabbits were all 0.0 for cornea opacity, iris, conjunctivae and chemosis score, respectively. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.
A second insufficiently documented eye irritation study was performed in 9 albino rabbits according to a protocol similar to OECD 405 (WoE, 1972). 0.1 mL of the undiluted substance was applied to one eye of each rabbit. The contralateral eye was left untreated and served as control. The test substance was washed with lukewarm water in 3 rabbits 2 seconds and in other three rabbits 4 seconds after instillation. The eyes of three rabbits remained unwashed. The test substance produced mild conjunctival irritation 24 h after instillation without washing, reversible within 48 h. No changes on iris and cornea were observed. In rabbits in which the treated eyes were washed after 2 or 4 seconds no irritation was observed at any observation time point. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.
Conclusion:
Based on all available information on eye irritation toxicity from a weight-of-evidence approach, the target substance Castor oil, ester with glycerol (CAS 68459-67-6) was not irritating to the eyes.
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) No 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.