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.

Arcelin. G (2001) Mark 17M: Acute Dermal Toxicity Study in Rats. Testing Laboratory: RCC Ltd, Toxicology Division, Wölferstrasse 4, CH-4414, Füllinsdorf Switzerland Owner company: Crompton Vinyl Additives GmbH, Chemiestrasse 22, D-68623 Lampertheim, Germany Report No.: 785687 Report date: 2001-06-21
Sarasin G. 1981 Acute Dermal LD50 in the Rat of TK 10'701 Testing Laboratory: CIBA-GEIGY Limited, Basle, Switzerland. Owner company: Plastics and Additives Division, CIBA-GEIGY MARIENBERG GMBH, 6140 Marienberg Post Bensheim Report No.: 810905 Report date: 1981-09-17
Both studies were Acute dermal toxicity studies which included local reaction observations during the course of the study.
Two in vitro studies were provided as supporting information.
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

Read across from DBT-2EHMA (CAS: 10584-98-2) has been used for these endpoints as this is considered the most structurally similar organotin substance with regards to diisotridecyl 3,3'-[(dibutylstannylene)bis(thio)]dipropionate.

Skin irritation:

The two acute dermal studies available for assessment were provided as a weight of evidence to fulfil the data requirement. Both studies were performed on the read across substance DBT-2EHMA. Arcelin 2001 was performed to GLP and in compliance with the appropriate guideline for assessing the acute dermal toxicity of the substance. Sarasin (1981) was performed to a method comparable to the appropriate guideline for assessing acute dermal toxicity. As such the observations of irritation and corrosion were considered to have been performed to a good scientific standard and as such the studies were both assigned reliability scores of 2 and considered adequate for assessment. Both studies reported necrosis, in Sarasin (1981), these effects were noted in doses as low as 250 mg/kg bw.

In the two in vitro studies, provided as supporting information, 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. 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".