Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate

Endpoint summary

Description of key information

non-skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The evaluation of the skin sensitisation potential of the substance was done by considering data on Similar Substance 03 due to the absence of available data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.

The study was performed to determine the sensitizing potential of the topically applied test substance according to the OECD guideline 429 and EPA OPPTS 870.2600 in compliance with GLP. The test substance concentrations used in the main LLNA study were chosen such that the maximum concentration tested was the highest achievable solution of the test substance in the vehicle, while avoiding both overt systemic toxicity and excessive local dermal-irritation. Concentrations of 25, 50 and 100 % (v/v) were chosen. Five animals per group were treated by topical application of the test substance concentrations, vehicle or positive control in the same manner as in the screen. A naive group of five animals was sham-treated. DMF was chosen as the vehicle, based on solubility. 

Topical application of the test substances a 25 and 50 %(v/v) in the DMF vehicle, and at 100 % (v/v), resulted in SI values less than 3 (SI < 3.0) - at 100 % group SI: 0.5, at 50 % SI: 0.4, at 25 % group SI: 0.7. Therefore, the test substance is not a skin sensitizer in the LLNA.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC) No.1272/2008, Annex I: 3.4.2.2.3.2.the following categories for skin sensitisation classification apply:

Category 1

Substances shall be classified as skin sensitizers in category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test.

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria:

Local lymph node assay-EC3 value ≤ 2 %

Guinea pig maximisation test-≥ 30 % responding at ≤ 0.1 % intradermal induction dose or ≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose

Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0.2 % to ≤ 20 % topical induction dose

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Local lymph node assay - EC3 value > 2 %

Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.

Buehler assay - ≥ 15 % to < 60 % responding at > 0.2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.

The topical application of the test substances at 25 and 50 %(v/v) and at 100 % (v/v), resulted in SI values less than 3 (SI < 3.0); no EC3 was therefore determined. Based on the afore-mentioned criteria, the substance is not classified for skin sensitisation.