Registration Dossier

Administrative data

Description of key information

SKIN
Key Study: Rush (1993): Corrosive to the skin of rabbits.
EYE
The available data demonstrate that the substance is severely irritating/corrosive to the rabbit eye; Bukva (1971), Drake (1973), Sachsse (1973)

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin was chosen on the basis that it was conducted in accordance with the OECD 404 guideline and to the GLP standard. Many of the supporting studies were performed in a similar manner to OECD 404 and stated that the material was either corrosive or irritating, with the exception of the Sachsse (1973) study, which stated that dimethyltin dichloride was a mild irritant to rabbit skin. However, the results table of this study were not included and so this study cannot be considered as key in any case.

A weight of evidence approach was used for the eye irritation, as no one study could be considered as reliable above the others. All three studies state the material is either corrosive, or very irritating, which would lead to the highest classification possible for eye irritation.


Justification for selection of skin irritation / corrosion endpoint:
The Rush (1993) study was chosen on the basis that it was conducted in accordance with the OECD 404 guideline and to in compliance with GLP and therefore assigned a relibility score of 1. All other data submitted for this endpoint was assigned a reliability score of 2 as they contained acceptable but with minor deviations that would not affect the overall quality of the conclusions.

Justification for selection of eye irritation endpoint:
A weight of evidence approach was used for the eye irritation, as no one study could be considered as reliable above the others. All three studies demonstrated severe effects and concluded that the substance is either corrosive, or very irritating, which would lead to the highest classification possible for eye irritation.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

In accordance with the criteria outlined in Regulation (EC) No. 1272/2008 (CLP), the substance meets the following criteria for classification for irritation/corrosion:

Skin: 'Skin Corrosion 1B' with the associated hazard phrase H314 'Causes severe skin burns and eye damage'

Eye: 'Eye Damage 1' with the associated hazard phrase H318 'Causes serious eye damage'

The classification Skin Corrosion 1A: H314 is not applied, as no testing is available to demonstrate corrosive effects in ≤ 3 minutes.

In accordance with the criteria outlined in Directive 64/548/EEC (Dangerous Substances Directive), the substance meets the following criteria for classification for irritation/corrosion:

Skin: 'Corrosive' with the associated risk phrase R34 'Causes burns'

Eye: 'Irritant' with the associated risk phrase R41 'Risk of serious damage to eyes'

The risk phrase R35 (Causes severe burns) is not applied, as no testing is available to demonstrate corrosive effects in ≤ 3 minutes.