Registration Dossier

Administrative data

Description of key information

Skin Irritation/Corrosion
The following two studies were submitted to fulfil the data requirement under skin irritation and corrosion.
Warren, N (2010) IN VITRO SKIN CORROSION IN THE EPISKIN(TM) RECONSTITUTED HUMAN EPIDERMIS MODEL. Testing Laboratory: Harlan Laboratories Ltd., Shardlow Business Park, London Road, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM. Report No.: 3109/0003. Report date: 2010-08-09.
Warren N (2010) DETERMINATION OF SKIN IRRITATION POTENTIAL USING THE EPISKIN(TM) RECONSTITUTED HUMAN EPIDERMIS MODEL. Testing laboratory: Harlan Laboratories Ltd., Shardlow Business Park, London Road, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM. Report No.: 3109/0004. Report date: 2010-07-19.
As both studies were conducted in compliance with GLP and to validated in vitro methods, the studies were considered adequate and reliable for assessment and both were assigned reliability scores of 1. Both studies produced negative results.
Eye Irritation
The key study submitted to address the data requirement eye irritation was as follows:
Kobel W (1981) Report on Eye Irritation in the Rabbit After Single Application of TK 11'638. Testing laboratory: CIBA-GEIGY Limited, Basle, Switzerland. Owner company: CIBA-GEIGY Limited, Basle, Switzerland. Report No.: 811186. Report date: 1981-12-28.
The study was performed to methods equivalent to OECD 405 and EU Method B.5. The study was assigned a reliability score of 2. The test material was found to induce eye irritation in the White New Zealand Rabbit.

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

Skin irritation:

In the two in vitro studies evaluating the skin irritation and skin corrosion potential (both Warren, 2010) both using the EpiskinTM reconstituted human epidermis model, the substance was considered to not be corrosive or irritating to the skin. However, these results are not consistent either with findings in an acute dermal toxicity study in which animals treated with the undiluted substance at 2000 mg/kg were terminated on humane grounds on day 8 because they were suffering severe irritation or with the proposed classification with R38 under 67/548/EEC. On this basis the substance is considered to be irritating to skin and requires labelling with R38.

Eye irritation:

In Kobel, 1981, the primary eye irritation of TK 11638 (a similar substance to the registered substance) on New Zealand White rabbits was examined in a method similar to OECD 405 and EU method B.5. The study was assigned a reliability score of 2 in line with the criteria set out in Klimisch (1997). The test material was found to be irritating to the eyes. Rinsing the eyes following instillation was of practically no effect. The test material was classified according to 67/548/EEC as R36 - Irritating to the eyes, based upon the test results.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Proposed classification according to 67/548/EEC was as Xi; R36/R38 Irritant; Irritating to eyes and skin. Although an in vitro study for dermal irritation potential gave opposite results (i.e. not-irritating), effects observed in an acute dermal study support the proposed classification. Classification for eye irritation is based upon the mean scores for oedema of the conjunctivae (chemosis) which persisted for the duration of the test (7 days). Under regulation (EC) No 1272/2008, the following classification is proposed. Skin irritation Category 2, (H315) and Irritating to eyes Category 2 (H319), and the signal word "Warning".