Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The skin irritation study was performed 1974, following the DOT (Transport Classification) Guidelines, before GLP- and OECD-testing guidelines wereavailable and in force and amended in year 1991 (Addendum to Lonza Report No. 0012). A couple of substances were tested in one study. 
The intact and abraded skin of 6 albino rabbits was employed for this study.
The experimental procedure in the eye irritation key study complied with EEC Methods for determination of toxicity Directive 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B5 Acute toxicity (eye irritation).
Three New Zealand White strain albino rabbits were chosen as it has been shown to be a suitable model for eye irritation studies and is the animal
recommended in the test protocol.

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)

Additional information

In the skin irritation study a series of 6 rabbits were used for testing. The patches were secured to the area by thin bands of adhesive tape (occlusive application). The material to be tested (0.5 g) was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

No erythema and no oedema were observed during the test period.

Therefore, Acetoacet-o-toluidide is not irritating to rabbit skin.

In the eye irritation study the test substance was administered as supplied by the Sponsor. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.

No corneal damage or iridial inflammation was seen throughout the observation period. Mild conjunctival inflammation was evident in all three animals. All reactions had resolved by the following day.

In conclusion, the test item is not irritating to the rabbit eye.

Justification for classification or non-classification

Acetoacet-o-toluidide is not irritating to rabbit skin and therefore will not be classified according to GHS.

All reactions in the eye irritation study had resolved by the following day.

In conclusion, the test item is not irritating to the rabbit eye and therefore has not been classified according to GHS.

Categories Display