reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

Endpoint summary

Description of key information

3-{[3-(acryloyloxy)-2.2-dimethylpropanoyl]oxy}-2.2-dimethylpropyl acrylate was shown to have sensitisation potential (sensitizer) in the Local Lymph Node Assay. The calculated EC3 value was 1.4 %(w/v).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitisation study in mice (Kanizsai 2017):

The aim of the study was to determine the skin sensitisation potential of 3-{[3-(acryloyloxy)-2.2-dimethylpropanoyl]oxy}-2.2-dimethylpropyl acrylate following dermal exposure. The study was performed with vertebrate animals as no full regulatory in vitro alternative is available. The minimum number of animals was used, corresponding to the regulatory guidelines being followed. 

The Preliminary Irritation/Toxicity Tests was performed in CBA/CaOlaHsd mice using five doses (2 animals/dose): 100 % (undiluted), 50%, 25%, 10 % and 5% (w/v) in AOO. Based on the observations recorded in the preliminary test, the 5 % (w/v) was selected as top dose for the main test.

In the main assay, twenty-four female CBA/CaOlaHsd mice were allocated to six groups of four animals each: - four groups received 3-{[3-(acryloyloxy)-2.2-dimethylpropanoyl]oxy}-2.2-dimethylpropyl acrylate (formulated in AOO) at 5% (w/v) , 2.5% (w/v), 1% (w/v) and 0.5% (w/v) concentrations, the negative control group received the vehicle (AOO) and the positive control group received 25 % (w/v) HCA (dissolved in AOO).

The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).

No mortality or signs of systemic toxicity were observed during the main study. No test item precipitate was observed. Slightly rigid ear was observed for three animals of the 5% (w/v) dose group on Day 3. No treatment related marked body weight loss (=5%) was observed on the mean body weight changes of the groups. Marked body weight loss (=5%) was observed for two animals of the 5% (w/v) dose group and the positive control group and for one animal of the 2.5% (w/v) and 1% (w/v) dose groups. There were no indications of any irritancy at the site of application.

The stimulation index values were 12.0, 6.2, 1.8 and 1.1 at concentrations of 5%, 2.5%, 1% and 0.5 % (w/v), respectively.

In conclusion, under the conditions of the present assay, 3-{[3-(acryloyloxy)-2.2-dimethylpropanoyl]oxy}-2.2-dimethylpropyl acrylate, tested in a suitable vehicle, was shown to have sensitisation potential (sensitizer) in the Local Lymph Node Assay. The calculated EC3 value was 1.4 %(w/v).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the experimental results, 3-{[3-(acryloyloxy)-2.2-dimethylpropanoyl]oxy}-2.2-dimethylpropyl acrylate should be classified as skin sensitisazing, category 1, subcategory 1A according to the Regulation EC N°1272/2008.

Justification : in the Local Lymph Node Assay, the EC3 value was 1.4 %.