Registration Dossier

Administrative data

Description of key information

The following studies were submitted to fulfil the skin irritation/corrosion and the eye irritation endpoints :
Skin irritation/corrosion:
Kobel, W (1981) SKIN IRRITATION IN THE RABBIT AFTER SINGLE APPLICATION OF TK 11637 Testing laboratory: Ciba Geigy Ltd, Basle, Switzerland 81 0817. Owner company: Plastics and Additives Division Report date: 1981-09-29
Sarasin, G (1981) Acute Dermal LD50 in the rat of TK 11.637 Testing laboratory: Ciba Geigy Ltd, Basle, Switzerland Owner company: Plastics and Additives Division. Report no.: 81 0907. Report date: 1981-10-15
Eye irritation:
Kobel, W (1981) EYE IRRITATION IN THE RABBIT AFTER SINGLE APPLICATION OF TK 11.637 Testing laboratory: Ciba Geigy Ltd, Basle, Switzerland. Owner company: Plastics and Additives Division. Report no.: 81 0816 Report date: 1982-07-30

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin: A weight of evidence approach was taken to fulfil the data requirement for skin irritation

The Kobel, (1981) study was considered to be comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion). A reliability rating of 2 was assigned according to the criteria of Klimisch, 1997, as it is comparable to guideline study with acceptable restrictions, however there was no data on purity or GLP. New Zealand White rabbits were exposed to the test material for 24 hours using an occlusive wrap. Under the conditions of the study the test material was found to cause an extreme irritation when applied to intact and abraded rabbit skin. The test was ended after the second reading for humane reasons.

Sarisan G (1981), an acute dermal toxicity study was provided as part of a weight of evidence to assess the skin irritation/corrosion of the substance. The study was performed to a good scientific standard. 5 rats per sex per dose were exposed to the test material for 24 hours, the test material was then washed off and observations were performed for 14 days. The whole treated area of the skin became necrotic and started to slough off seven days after the application of the test material. To avoid unnecessary suffering the experiment was therefore terminated after one instead of two weeks. Although the exposure of the test material to the skin was extended in comparison to standard irritation test methods, the severity of the effects described were indicative of dermal corrosion.

 

Eye:

The Kobel, 1981 study was chosen as the key study for eye irritation as it was considered to be comparable to the OECD Guideline 405 (Acute Eye Irritation / Corrosion). A reliability rating of 2 was assigned according to the criteria of Klimisch, 1997, as it is comparable to guideline study with acceptable restrictions, however there was no data on purity or GLP. This was considered to be the most reliable study. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently, closed for a few seconds. At the end of exposure three of the animals’ eyes were rinsed, the remaining three were unrinsed. The right eye was not treated and served as an untreated control. The test material was found to cause an extreme irritation when applied to the rabbit eye mucosa. The conjunctival damage was maximum in all animals at both readings. Corneal and iris damage could be estimated only in less than half of the eyes due to the extreme chemosis. The test was ended after 48 hours for humane reasons.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin:

Due to the nature and severity of effects noted in the presented studies, the substance should be classified under Directive 67/548/EEC and Regulation (EC) No 1272/2008, the substance is classified as corrosive to the skin and should be labelled with C (Corrosive) R34 (Causes burns), and H314 (Causes severe burns and eye damage) with the signal word "danger" respectively.

Eye:

Due to the nature and severity of the effects seen in the available in vivo study, the substance under Directive 67/548/EEC requires the following classification, R41, Risk of serious damage to the eyes. In accordance with Regulation (EC) No 1272/2008, the test substance is classified as a Category 1 irritant and thus should be labelled with hazard statement H318: causes serious eye damage and the "danger" symbol.

However, according to Section 3.2.6.2 of Directive 67/548/EEC when a substance is classified as R34, the risk of severe damage to eyes is considered implicit and R41 is not included in the label. Likewise under the Regulation (EC) No 1272/2008, Section 3.3.2.3 skin corrosive substances shall be considered as leading to serious damage to the eyes as well (Category 1) and hence H318 is not included in the label.