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EC number: 701-252-0 | CAS number: -
LLNA (OECD429, GLP): sensitising
Tables and figures have been included in the attached document "LLNA tables and figures".
Preliminary irritation study:
The results of the epidermal exposures for the selection of highest test substance concentration to be tested in the main study are described in the table. Based on these results, the highest test substance concentration selected for the main study was a 100% concentration. See also Table 1 in the attached document LLNA tables and figures
The slight irritation of the ears as shown by all animals treated at 50 and 100% was considered not to have a toxicologically significant effect on the activity of the nodes. No oedema was observed in any of the animals examined.
All auricular lymph nodes of the animals of the control groups and animals at 25% were
considered normal in size. A few auricular lymph nodes at 50% and the majority of nodes at 100% were enlarged in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
The results of Standolized Linseed Oil (SLO) can be read across to Standolized Soybean Oil (SSO) as SLO and SSO share similar structures and reactivity, based on the fatty acids composition of the raw material oils. Due to higher level of polyunsaturated fatty acid chains, SLO presents the worst case scenario in terms of toxicology. (see read across document for further details)
A Local Lymph Node Assay was performed with Standolized Linseed Oil in accordance with OECD 429 and under GLP-conditions. The results indicate that the test substance 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 29.2% was calculated.
After receiving the result of the LLNA study, the manufacturers of the substance contacted their company physician and asked their employees about any case of a skin reaction to the substance. Some company physicians even issued detailed questionnaires based on the LLNA result. The conclusion of these investigations is that during decades of manufacturing this substance, 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.
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, the substance is 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 this substance. All the company physicians of the manufacturers confirm this assumption. Therefore, the outcome of the LLNA study 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)).
No study is available to address the possible respiratory sensitisation of Standolized Soybean Oil. Based on the very low vapour pressure of the substance, no respiratory sensitisation is expected.
Based on the available information Standolized Soybean Oil does not need to be classified for skin or respiratory sensitisation in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2002/EC.
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