1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Additional information:

The skin sensitizing potential of the test substance was assessed using the radioactive Murine Local Lymph Node Assay (OECD TG 429; Val 1). Groups of 5 female CBA mice each were treated with 50% w/w preparations of the test substance in methyl ethyl ketone (MEK) or with the vehicle alone (BASF SE, 2011). The 50% preparation was the maximum technically applicable concentration shown in a pre-test to induce no signs of local irritation or systemic toxicity.

Each test animal was treated with 25 μL per ear of the appropriate test-substance preparation, applied to the dorsal surfaces of both ears for three consecutive days, while the control group was treated with 25 μL per ear of the vehicle alone. 3 days after the last application the mice were injected into the tail vein with 20 μCi of [3H]-thymidine in 250 μL of sterile saline, and about 5 hours thereafter, the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring [3H]-thymidine incorporation (indicator of cell proliferation). Cell counts and weights of each animal’s pooled lymph nodes were also determined. In addition, a 0.8 cm diameter sample was punched out of the apical part of each ear and for each animal the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.

No signs of systemic toxicity were noticed in all animals during the observation period. The test substance also did not induce a biologically relevant (no increase above the cut off Stimulation Index of 3) or statistically significant increase of [3H]-thymidine incorporation into the cells from the auricular lymph nodes. There were no statistically significant or biologically relevant increases in lymph node cell counts (no increase to 1.5 fold or above of control value = stimulation index ≥1.5) and lymph node weights as well. The 50% test-substance solution caused some statistically significant increase in ear weights, but only in the presence of test substance residues noticeable on the ear skin of the mice on study day 2, only.

It is therefore concluded that the test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen. The study was conducted according to the OECD test guideline 429 (GLP, Val 1), without any deviations, and is therefore considered sufficient for assessment and classification.

Migrated from Short description of key information:
- Skin sensitisation: not sensitising (LLNA; OECD TG 429, mouse; BASF SE 2011).

Respiratory sensitisation

Endpoint conclusion

Additional information:

Migrated from Short description of key information:
- Respiratory sensitisation: No data available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification (skin sensitisation). Based on the criteria for classification of Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, no classification is warranted.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are considered reliable and suitable for the purpose of classification (skin sensitisation). Based on the criteria laid down in Regulation (EC) No.1272/2008, as amended for the second time in Directive EC 286/2011, no classification is warranted.