Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The substance is both irritating to skin and eyes.

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)

Additional information

Respiratory irritation:

No data on respiratory irritation are available for the test material.

Skin Irritation/Corrosion:

This substance was applied to New Zealand White rabbits on two separate sites on each animal under semi-occlusive dressing for four hours. The test sites were washed with either mineral oil or isopropanol. The test sites were evaluated in accordance with Draize which resulted in an average (24, 48, 72 hour) erythema of 2.83 and edema of 2.33 for sites washed with mineral oil and 3 and 3.06 for sites washed with isopropanol. All sites washed with mineral oil returned to normal by Day 14. Necrosis and fissuring was observed in sites wiped with isopropanol and only partial reversibility was observed by Day 14.

Serious eye damage/irritation:

This substance produced a positive eye irritation response in New Zealand White rabbits. The mean (24, 48, 72 hour) cornea opacity, iritis, conjunctivitis and chemosis scores were 1.33, 0.94, 2.89, and 3.56, respectively. None of the effects were fully reversible within 21 days.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin Irritation/Corrosion:

In accordance with Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is required for skin irritation.

Serious eye damage/irritation:

In accordance with Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is required for eye irritation.

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