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 delayed contact hypersensitivity potential of e-caprolactone was investigated in CBA/Ca mice, in a GLP study according to OECD method 429 (Robertson, 2010). Following a preliminary study, three groups of 5 female mice were treated with concentrations prepared at 25%, 50% and 100% for 3 consecutive days. Three days after the final application each animal received an intravenous injection of [methyl-³H] thymidine into the lateral tail vein, and 5 h later the draining lymph nodes were collected. There were no signs of systemic toxicity noted and body weight changes were considered to be normal. The stimulation index (SI) values for the mice treated with e-caprolactone at concentrations of 25%, 50% or 100% when compared with the control group, were 1.1, 1.2 and 0.9, respectively. Under the conditions of the study, since treatment with e-caprolactone at concentrations of up to 100% did not achieve a stimulation index of ≥3, it was considered that the test item does not have the potential to cause skin sensitisation.


Migrated from Short description of key information:
No evidence of skin sensitisation potential was seen in a modern LLNA. There are no case reports of skin or respiratory sensitisation.

Respiratory sensitisation

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

There is no evidence that the substance has the potential to cause respiratory sensitisation.


Migrated from Short description of key information:
No experimental data are available; there is currently no validated test mehtod for the assessment of respiratory sensitisation potential. There are no reports from exposed workers that the substance has the ability to cause occupational asthma.

Justification for classification or non-classification

No evidence of skin sensitisation potential was seen in a modern LLNA; no further data are available. There is no indication from exposed workers of a potential to cause occupational asthma. The available data do not indicate that e-caprolactone requires classification as a skin or respiratory sensitiser according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (the CLP Regulation).