Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

After short term skin exposure no adverse effects were recorded.

Exposure of eyes resulted in severe irritation in some cases with permanent effects.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: all available studies indicate no potential of the test material for skin irritation

Eye irritation: several old studies with limited documentation are available that indicate no eye irritation potential of the test material. However, in one old and one recent study moderate to severe effects were documented. The older study was disregarded because the report gave no information on the purity of the tested sample and the effects reported were not supported by other studies.

The most recent study was selected as key study and indicates a moderate irritation hazard.

Justification for classification or non-classification

Based on criteria in the CLP Regulation (EC 1272/2008), a susbtance is classified as:

irritating to skin (category 2), if, when applied on skin of an animal, a substance produces:

- mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

irritating to eyes (category 2) if, when applied to the eye of an animal, a substance produces:

— at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

the substance is not classified as skin irritant.

Based on effects reported in the key studies, the substance is not classified for skin irritation while it is classified as eye irritant, category 2 (H319).