Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating (OECD 404, GLP, K, Rel.2)

Eye irritation: not irritating (OECD 405, GLP, K, Rel.2)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A key study was identified (TNO, 1981). In this skin irritation study performed similarly to the OECD Guideline No. 404. A single 4-Hour, semi-occluded application of the test item to the intact skin of six rabbits and to the abraded skin of six other rabbits produced slight to moderate skin irritation. Its dermal effects generally consisted of very slight or well-defined erythema, very slight edema and slight scaliness. There was no significant differences between skin reactions of the intact skin and those of the abraded skin. The individual scores for each intact skin's animal within 2 scoring times (24 and 72 h) were 2.0/1.5/0.5/1.5/1.5/2 for erythema and 0.5/0.5/0.0/0.5/0.5/1.0 for oedema.

The test substance is considered to be non-irritant for the skin.

Eye irritation:

A key study was identified (TNO, 1981). In this eye irritation study performed similarly to the OECD guideline 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into one eye of 6 New Zealand White rabbits. The eyes were not rinsed after the instillation of the test substance. Animals were observed at 24 and 72 h after treatment and graded according to the Draize method.

The calculated mean scores for each animals within 2 scoring times (24 and 72 h) were 0.0 for all animals for the corneal opacity and iridial inflammation and 0.5/0.0/0.0/0.0/0.0/0.0 for conjunctival redness and chemosis.

The substance is therefore not classified for eye irritation.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Based on the available data:

- no additional self-classification is proposed regarding skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP)

- test substance is classified as Cat.3 (mild skin irritation) according to the GHS.

- no additional self-classification is proposed regarding eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.

No data was available regarding respiratory irritation. However, the substance not being skin or eye irritant, no classification is expected for respiratory irritation .