Castor oil, ester with sorbitol

Endpoint summary

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

Reference

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”.

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.