2'-chloroacetoacetanilide

Endpoint summary

Description of key information

The skin irritation key 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. 0096). A couple of substances were tested in one study. 
The intact and abraded skin of 138 albino rabbits was employed for this study.
The second skin irritation supporting study was performed 1965, before GLP- and OECD-testing guidelines were available and in force and amended 
in year 1989 according to Guideline 83/467/EWG.  The test item was administered intracutaneously to shaved rabbits according to Barail-Test 
Method. 
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 key 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.

Only very slight erythema (score 1 respectively 2) was noted in all 6 animals 4h hours after removal of the patch. After 24 hours, score 1 was still noted in two animals after removal of the patch. These findings were completely reversible within 48 hours. No oedema were observe during the test period.

Therefore, Acetoacet-o-chloranilide is not irritating to rabbit skin

In the intradermal test in rabbits the Barail-Test Method model is for assessing dermal tolerance to chemical substances. The test material was administered intracutaneously to shaved rabbits through a fine syringe, the animals were killed after 24 hours and the treated skin was removed, dried and assessed for reaction area, erythema and oedema.

Due to the test results, Acetoacet-o-chloranilide is not irritating to the rabbit skin.

In a further test, 5 times in 5 days a 10% and 1% solution was applied to the intact and shaved rabbit skin (occlusive) in a volume of 0,5 ml.

In the third test, the mucosa irritation was determined using 0,1 ml of the 10% and 1% solution in single application to the conjunctiva of the rabbit eye.

In the eye irritation key 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 two or three days after instillation.

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

Justification for classification or non-classification

All findings in all three studies were completely reversible within 48 hours.

Therefore, Acetoacet-o-chloranilide is not irritating to rabbit skin (irritation index 0.2) and therefore will not be classified according to GHS.

All reactions in the eye irritation study had resolved two or three days after instillation.

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