Registration Dossier

Administrative data

Description of key information

OECD TG 404: irritating
OECD TG 405: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Studies were chosen as key when the available study was of relevance and of sufficient quality for classification, labelling and for risk assessment.

There are two reliability score 2 studies for each of skin and eye irritation. Therefore the most recent of the studies were selected as the key studies. For eye irritation the second study supported the findings of the key study. For skin irritation the supporting study gave a result of not irritating, and was therefore not in agreement with the key study. However, this study appeared (based on translation of the German report) to be limited in its reporting of observations after 72 hours.

In the key skin irritation study according to OECD TG 404 trimethoxy(propyl)silane was irritating to the skin of rabbits. Erythema or edema were seen for up to 8 days, scaling continued to study termination at 14 days (limited information appears to be presented on observations post-72h) (ASTA-WERKE, 1987).

In the key eye irritation study according to OECD TG 405 redness of the conjunctivae was the most prominent effect of the test substance. It was seen in all three animals to a varying degree ( score: 0.33 - 2.67, mean over 24, 48 and 72 h). Nevertheless the scores in the report indicate that the test material is not classified irritating to the eyes of rabbits. All effects were reversible within six days of treatment (Toxikologie Degussa-Asta, 1987).

Justification for selection of skin irritation / corrosion endpoint:
The key study was selected for assessment.

Justification for selection of eye irritation endpoint:
The key study was selected for assessment.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The available data on eye irritation of the registered substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification. Regarding skin irritation, the registered substance is classified as 'Skin Irritant Category 2', with the hazard statement 'H315: Causes skin irritation'.