Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In a Local Lymph Node Assay, comparable to OECD 429, 6 female CBA mice per dose were treated with 0, 1, 3 and 10 % of the test material under standard conditions (Project No. 45H0114/042015, BASF AG 2004). In the first step, concentrations of 1, 3 and 10% of the test substance in acetone were used. As lymph node reactions and increases in ear weight were produced by all concentrations, in the second step concentrations of 0.1, 0.3 and 1 % were examined in order to determine a concentration not inducing lymph node reactions. Each test animal was applied with 25 µL per ear of the respective test substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 µL per ear of the vehicle alone. Three days after the last application the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the cellular content (indicator of cell proliferation) and weight of each animal's pooled lymph nodes. Moreover, a defined area with a diameter of 0.8 cm 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. The test substance induced a statistically significant and biologically relevant proliferation of the auricular lymph nodes and cell counts when applied as 1, 3 and 10% test substance preparation in acetone to the ear of the mice. A statistically significant increase in lymph node weights but not in lymph node cellularity was observed at the test substance concentration of 0.3%. The increased ear weights (6 to 38% in the treatments 1 to 10%) and clinical signs of skin irritation (incrustation in 5 animals, scaling in 1 animal applied with the 10% test substance preparation and incrustation in 1 animal applied with the 3% test substance preparation) indicated a significant irritant property of the test substance at concentrations of 1%, 3% and 10%.

 

Based on the available data, no EC3 or EC1.5 value could be determined. The threshold concentration for sensitization induction based on cell count lay between 0.3% and 1% indicative of a sensitizer of strong potency according to the criteria described in the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, December 2010). Accordingly, classification and labeling of the substance according to the criteria of Regulation (EC) No. 1272/2008 (CLP) as amended for the 2nd time in Commission Regulation (EU) No. 286/2011 as a skin sensitizer subcategory 1A is warranted.

 

 

Sensitizing properties of the test material was also shown in a second LLNA, comparable to OECD 429 (Project No. 56H0114/042018, BASF AG 2004). Groups of 6 CBA male mice were used for this study. Twenty-five µL of a 3% preparation of Glycerin3EOTA in acetone (challenge phase group) or the vehicle (induction phase and control group) were applied to the left and right flank of 6 mice per group for three consecutive days. Fourteen days after the first application 25 µL of a 1% TS preparation in acetone (induction and challenge phase group) or the vehicle (control group) were applied to the backs of both ears for 3 consecutive days. Three days after the last application, the animals were sacrificed and the auricular lymph nodes of both sides, as well as a defined area of both ears were sampled. The weight and the cellular count of pooled lymph nodes per animal were determined. In addition, the weight of the ear tissue and the body weight change over the study period were determined. No signs of systemic toxicity were noticed. When compared with the control group, the test substance induced a statistically significant increase of lymph node cellularity and lymph node weights in both the induction phase and challenge phase group when applied as a 1% test substance in acetone to the ear of the mice. This result confirmed the results of the previous LLNA (Project No. 45H0114/042015). In addition, ear weights were statistically elevated in the induction phase and challenge group, which also had been the case in the previous regular LLNA. When comparing the result of the challenge phase group (test group 3) with those of the induction phase group (test group 2), a statistical significance was seen in the lymph node weights, but not in lymph node cell count and ear weights. The statistically significant increase of lymph node weights in the challenge phase group when compared with the induction phase group, together with some increase in cell counts in the challenge phase group, is considered to represent an indication of sensitizing effect of the substance.


Migrated from Short description of key information:
Mouse, LLNA: sensitizing (comp. OECD 429, BASF AG 2004)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No information is available.


Migrated from Short description of key information:
No information is available

Justification for classification or non-classification

Glycerol, ethoxylated, esters with acrylic acid was demonstrated to be a skin sensitizer.

The substance will therefore be classified as sensitizing according to EU (R43) and GHS (category 1A) criteria.

 

There are no data available to classify Glycerol, ethoxylated, esters with acrylic acid as a sensitizer of the respiratory tract.

Thus, based on the available data, classification of the substance concerning skin sensitization is warranted:

  • EU classification according to Annex VI of Directive 67/548/EEC: Xi, R43
  • GHS classification (REGULATION (EC) No 1272/2008 (CLP)) as amended for the 2nd time in Commission Regulation (EU) No. 286/2011: Skin sensitization subcategory 1A