Castor oil, oxidized

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

LLNA studies

For both read across substance Blown linseed oil and Blown rapeseed oil LLNA studies are available.

In the study with Blown linseed oil, SI values calculated for this substancewere 3.7, 8.2 and 19.6 for concentrations of 25, 50, and 100%, respectively. These results indicate that Blown linseed oil could elicit an SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 18.5% was calculated.

In the study with Blown rapeseed oil, there was no indication that the substance elicit an SI ≥ 3 when tested up to 100%. The median SI values calculated for the substance concentrations 25, 50 and 100% were 1.7, 2.8 and 2.8 respectively.

Human data

After receiving the result of the LLNA study with Blown linseed oil, the manufacturers of the blown oils, including Blown castor oil, contacted their company physician and asked their employees about any case of a skin reaction to the substances. Some company physicians even issued detailed questionnaires based on the LLNA result. The conclusion of these investigations is that during decades of manufacturing these substances, at different locations in the EU, not a single case of a skin reaction has been reported, as confirmed in writing by the company physicians.

 

Conclusion

It is evident that a careful and scientific consideration of the weight of all the evidence needs to be taken into account. Since the beginning of the 20thcentury, blown oils are present in applications with a high potential for frequent skin exposure, like varnishes, coatings, paints and lacquers. Any indication of a skin sensitizing potential should have been noted for these substances. All the company physicians of the manufacturers confirm this assumption. Therefore, the outcome of the LLNA study with Blown linseed oil is regarded as a false-positive result, supported by investigations reported in the literature, that unsaturated fatty acid functions present in the substance, give a false-positive result in the LLNA study (Kreiling et al (2008); Basketter et al (2009)).

It is concluded that BLO and BRO are considered to be not skin sensitising. The result of are read across to BCO. This is considered justified because 1) of the reasons mentioned above (Human toxicity) and because 2) two oils in this are considered to be not skin sensitising.

Migrated from Short description of key information:
Skin sensitisation (LLNA, OECD 429): sensitising with RA substance Blown linseed oil
Skin sensitisation (LLNA, OECD 429): not sensitising with RA substance Blown rapeseed oil
Skin sensitisation (human health surveillance data): not sensitising

Justification for selection of skin sensitisation endpoint:
No specific study selected as a Weight of Evidence Approach was applied.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No study is available for respiratory sensitisation. However, no respiratory sensitisation is expected based on the absence of skin sensitising properties and the low vapour pressure of the substance.

Justification for classification or non-classification

Based on the available information, Blown castor oil does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex VI of 67/548/EC and Annex I of 1272/2008.