Registration Dossier

Administrative data

Description of key information

A reliable study on skin irritation/skin corrosion is available.

A reliable study on eye irritation/corrosion is available.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritancy potential of VC was tested in New Zealand White rabbit according to OECD 404. The test material produced a primary irritation index of 4.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material produced positive criteria in 3/3 rabbits and was classified as irritant for skin according to GHS and Regulation (EC) No 1272/2008.

The irritancy potential of VC to the eye of the New Zealand White rabbit was tested according to OECD 405. The test material produced a maximum total score of 65 and was considered to be at least a severe irritant (class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only). The test material was also considered to be irritant according to EU labelling regulations Commission Directive 93/21/EEC. It is reasonable to assume that the symbol Xi, the indication of danger Irritant and the highest risk phrase R41 (Risk of serious damage to eyes) are therefore required.

Justification for selection of skin irritation / corrosion endpoint:

reliable study on skin irritation

Justification for selection of eye irritation endpoint:

reliable study on eye irritation

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the data available, VC needs to be classified for skin irritation (cat 2, H315) and for serious eye damage (cat 1, H318) according to the:

-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),

-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures