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EC number: 307-007-0 | CAS number: 97488-70-5
- 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
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Castor oil, ester with sorbitol (CAS No: 97488-70-5). The studies are as mentioned below:
The Schwartz Prophetic Patch was conducted by peer reviewed journal on 50 human subjects to assess the skin sensitization potential of read across chemical under occlusive condition.The material was applied under occlusion for 72 hours. The occlusion was then removed and the skin site evaluated. Seven days later, the material was reapplied under occlusion for 72 hours. The patch was removed, and the site was evaluated.Neither the first nor the second application produced sensitization in the treated subjects hence the chemical was considered as not sensitizing to the human skin.
The above result was further supported by the another patch study conducted by peer reviewed journal for another read across substance on 49 patients suspected of having cosmetic contact dermatitis to assess its potential of causing contact sensitization.Patch tests (Finn chambers) were applied to the back for 48 h, and the test sites were examined at 30 minutes after patch removal, 1 day later, and 4 to 5 days after patch removal. None of the 49 patients patch-tested with test chemical had a positive reaction. Therefore the chemical was considered as not sensitizing to the skin.
Based on the above summarized studies for target chemical Castor oil, ester with sorbitol (CAS No: 97488-70-5) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization study of test chemical was conducted on humans to assess its skin irritating effects. - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 1. Not specified
2.- Age at study initiation: ≈20 to 70 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 72 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- not specified
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- not specified
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1.50 human subjects
2. 49 patients - Details on study design:
- 1.A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 72 hours
- Test groups: 50
- Control group: no data
- Site: no data
- Frequency of applications: no data
- Duration: 72 hours
- Concentrations:100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 day
- Exposure period: 72 hours
- Test groups:50
- Control group: no data
- Site: no data
- Concentrations: 100%
- Evaluation (hr after challenge): after 72 hours
2.Patch tests (Finn chambers) were applied to the back for 48 h, and the test sites were examined at 30 minutes after patch removal, 1 day later, and 4 to 5 days after patch removal. None of the 49 patients patch-tested with castor oil had a positive reaction. - Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Clinical observations:
- Neither the first nor the second application produced irritation or sensitization in the treated subjects.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 120
- Group:
- test chemical
- Dose level:
- Not specified
- No. with + reactions:
- 0
- Total no. in group:
- 49
- Clinical observations:
- None of the 49 patients patch-tested with test chemical had a positive reaction.
- Remarks on result:
- no indication of skin sensitisation
- Cellular proliferation data / Observations:
- 1. Neither the first nor the second application produced irritation or sensitization in the treated subjects.
2.None of the 49 patients patch-tested with test chemical had a positive reaction. - Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical Castor oil, ester with sorbitol (CAS No: 97488 -70 -5) was considered to be not sensitizing to the skin of humans.
- Executive summary:
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Castor oil, ester with sorbitol (CAS No: 97488 -70 -5). The studies are as mentioned below:
The Schwartz Prophetic Patch was conducted by peer reviewed journal on 50 human subjects to assess the skin sensitization potential of read across chemical under occlusive condition.The material was applied under occlusion for 72 hours. The occlusion was then removed and the skin site evaluated. Seven days later, the material was reapplied under occlusion for 72 hours. The patch was removed, and the site was evaluated.Neither the first nor the second application produced sensitization in the treated subjects hence the chemical was considered as not sensitizing to the human skin.
The above result was further supported by the another patch study conducted by peer reviewed journal for another read across substance on 49 patients suspected of having cosmetic contact dermatitis to assess its potential of causing contact sensitization.Patch tests (Finn chambers) were applied to the back for 48 h, and the test sites were examined at 30 minutes after patch removal, 1 day later, and 4 to 5 days after patch removal. None of the 49 patients patch-tested with test chemical had a positive reaction. Therefore the chemical was considered as not sensitizing to the skin.
Based on the above summarized studies for target chemical Castor oil, ester with sorbitol (CAS No: 97488-70-5) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Castor oil, ester with sorbitol (CAS No: 97488-70-5). The studies are as mentioned below:
The Schwartz Prophetic Patch was conducted by peer reviewed journal on 50 human subjects to assess the skin sensitization potential of read across chemical under occlusive condition.The material was applied under occlusion for 72 hours. The occlusion was then removed and the skin site evaluated. Seven days later, the material was reapplied under occlusion for 72 hours. The patch was removed, and the site was evaluated.Neither the first nor the second application produced sensitization in the treated subjects hence the chemical was considered as not sensitizing to the human skin.
The above result was further supported by the another patch study conducted by peer reviewed journal for another read across substance on 49 patients suspected of having cosmetic contact dermatitis to assess its potential of causing contact sensitization.Patch tests (Finn chambers) were applied to the back for 48 h, and the test sites were examined at 30 minutes after patch removal, 1 day later, and 4 to 5 days after patch removal. None of the 49 patients patch-tested with test chemical had a positive reaction. Therefore the chemical was considered as not sensitizing to the skin.
Based on the above summarized studies for target chemical Castor oil, ester with sorbitol (CAS No: 97488-70-5) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance Castor oil, ester with sorbitol (CAS No: 97488-70-5) and its structurally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Castor oil, ester with sorbitol (CAS No: 97488-70-5) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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