Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising potential of 2-(1-methylethoxy)ethyl acetate (CAS 19234-20-9) was investigated in a Local Lymph Node Assay (LLNA) in mice according to OECD guideline 429 and in compliance with GLP (Pooles, 2012).

In the study, 4 female CBA/Ca mice per test group were treated with test substance at concentrations of 25, 50 and 100% in acetone/olive oil (4:1 v/v). The test substance formulations were applied epicutaneously onto the dorsal part of each ear (25 µL/ear) for three consecutive days. On Day 6, animals were sacrificed and weight of the lymph nodes was determined. The cell proliferation of pooled lymph nodes from each experimental group was measured by counting the number of radioactive disintegrations per minute per lymph node and as the ration of ³HTdR incorporation into lymph node cells of test nodes relative to controls (Stimulation Index; SI). The historical positive control alpha hexyl cinnamic aldehyde at concentrations of 25% confirmed the sensitivity and reliability of the test system.

Disintegrations per minute per pooled lymph nodes for each test group were 2629.82, 2212.86 and 1940.34 at concentrations of 25, 50 and 100% of the test substance, respectively. Treatment with the test substance did not result in a significant increase of disintegrations per minute when compared to control (1762.69). Based on these results, stimulation indices of 1.49, 1.26 and 1.10 were calculated for test substance concentrations of 25, 50 and 100%, respectively. The test item will be regarded as a sensitiser if at least one concentration of the test item results in a threefold or greater increase in ³HTdR incorporation compared to control value. No systemic toxicity and no effects on body weights were observed.

Under the above mentioned conditions, the test substance was not found to be a sensitiser in the LLNA.

 

Conclusion for skin sensitisation

In conclusion, no evidence of skin sensitising properties were seen after treatment with 2-(1-methylethoxy)ethyl acetate (CAS 19234-20-9).


Migrated from Short description of key information:
Skin sensitisation: not sensitising

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data on skin sensitisation properties, 2-(1-methylethoxy)ethyl acetate (CAS 19234-20-9) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC and the data are therefore conclusive but not sufficient for classification. Data on respiratory sensitisation are not available.