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:

There is no data available on the skin sensitisation potential of docosanamide (CAS 3061-75-4). In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

A reliable study on skin sensitisation is available for the structurally related substance (Z)-Docos-13-enamide (CAS 112-84-5), which is used for read-across based on the analogue approach.

The skin sensitisation potential of (Z)-Docos-13-enamide (CAS 112-84-5) was investigated in a GLP-conform Local Lymph Node Assay (LLNA) according to OECD 429 (Vogel, 2010). In this study, the ears of 5 mice per group were topically treated with concentrations of 5, 10 and 25% (v/v) of the test substance in tetrahydrofuran or the vehicle alone for 3 consecutive days. Five days after the first topical treatment, the animals were sacrificed after they received an intravenous injection of ³H-methyl thymidine. The cell proliferation of pooled lymph nodes from individual animals was measured by incorporation of ³H-methyl thymidine and expressed as the amount of radioactive disintegrations per minute (DPM). The mean DPM/lymph node for each test group were 456.8, 474.5 and 396.5 at concentrations of 5, 10 and 25% (v/v) of the test substance, respectively, thus indicating no difference in DPM/lymph node compared to control (control DPM/node = 566.9). Stimulation Indices were calculated as ratio of respective DPM of the individual animals from the treated groups versus the mean DPM of the control group. Subsequently, group mean Stimulation Indices of 0.81, 0.84 and 0.70 were determined for the 5%, 10% and 25% group, respectively. Based on this data, no EC3 values of the test groups could be calculated, since none of the tested concentrations induced a stimulation index greater than 3. The historical positive control substance (hexyl cinnamic aldehyde in acetone:olive oil (4+1)) confirmed the sensitivity and reliability of the experimental technique. Under the above mentioned conditions, the test substance was not found to be a sensitiser in the LLNA.

Based on the results of the available study on the skin sensitisation potential of the structural analogue (Z)-Docos-13-enamide (CAS 112-84-5), it may be concluded that docosanamide (CAS 3061-75-4) is not skin sensitising.

Migrated from Short description of key information:
RA-S CAS 112-84-5, Skin sensitisation in vivo (OECD 429): not sensitising

Justification for selection of skin sensitisation endpoint:
There is only one study for skin sensitisation of a structurally closely related substance available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on the skin sensitisation potential of (Z)-Docos-13-enamide (CAS 112-84-5), which is structurally very closely related to docosanamide (CAS 3061-75-4) according to the criteria of Regulation (EC) No 1907/2006, Annex XI, 1.5, do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC; therefore, docosanamide (CAS 3061-75-4) is not expected to exert a skin sensitisation potential, either, and the data are conclusive but not sufficient for classification.