Sorbitan monostearate, ethoxylated

Endpoint summary

Description of key information

The skin sensitization potential of target chemical was assessedin various experimental studies which were conducted on guinea pigs and humans.The predicted data usingDanish QSAR databasehas also been compared with the experimental data.Based on the available key data and supporting studies,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. 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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studieshas been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemicaland its structurally similar read across substance.The predicted data usingDanish QSAR databasethe has also been compared with the experimental data and summarized as below;

 

The Schwartz prophetic patch test was conducted on human subjects to determine the skin sensitization potential of test chemical.The undiluted (100%) test chemical was applied onto the skin of 50 subjects and observed for skin reaction for 72 hours.None of the treated subjects showedany signs ofskin sensitizing effects.Hence the test material was considered as not sensitizing to the skin of human.

 

Another Schwartz prophetic patch test was conducted on 10 human subjects to assess the contact sensitization potential of test chemical.When the chemical was applied at a dose of 30% in water for 48 hours, no evidence of contact sensitization was observed in treated subjects. Hencetest chemical showed no sensitization potential when tested in a Schwartz prophetic patch test.

 

In next skin sensitization study conducted in 107,no known evidence of contact sensitization was observed when a cream containing the test chemical was applied at a dose of 6%. Therefore the test chemical was considered as not irritating to the skin of treated subjects.

 

Further, a baby lotion containing the test chemical was tested to evaluate its skin sensitizing efficiency.The chemical was applied at concentration of 1 % on 200 subjects. The test chemical causedminimal irritation and skin fatigue in 5 out of 200 subjects. Since no skin sensitization effects were observed, the test chemical was considered to be not sensitizing to the skin.

 

According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.

 

The overall results were supported by the Human maximization study conducted in 200 subjects. In induction, 5 successive patches were applied on to the skin of each subject at concentration of 6% for 48 hours exposure period. After a rest period of 10 days, the subjects were challenged at same concentration. TheSLS (sodium lauryl sulfate) treatment was performed before induction and challenge. None of the treated subjects had developed known signs of skin sensitization. Thus the test chemical wasas not sensitizing to the skin of treated subjects.

 

Based on the available data for the target chemical, supporting studies and read across substance,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. 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 and its structurally similar read across substance were observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.