Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The key skin irritation/corrosion study found the test material to be corrosive to the skin of a single rabbit (grade 8/8) after a 4-hour exposure in a study conducted in accordance with OECD 404 but not GLP (Hüls AG, 1989). Necrosis was also observed following a 1-hour but not a 3-minute exposure (extremely limited details are provided on the 1-hour and 3 minute exposures).
The key eye irritation study found the test material to be severely irritant to the eyes of a single rabbit in a reliable study conducted according to OECD 405 and GLP (Safepharm Laboratories Ltd., 1987).

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

There are no reliable studies for skin and eye irritation. Therefore the results of the skin and eye corrosion studies are summarised here and used for classification.

There is one reliable study for each of the skin and eye corrosion endpoints. Supporting studies also show that the test substance is at least an irritant, but these studies were extremely poorly reported and do not meet current guideline standards.

The key study for skin irritation was conducted in accordance with OECD 404 but not GLP (Huls AG, 1989). The test substance was found to be corrosive to the skin of a single rabbit following a 4-hour exposure (see Table 5.4.1). Necrosis was also observed following a 1-hour but not a 3-minute exposure (extremely limited details on the 1-hour and 3 minute exposures available).

The key study for eye irritation was conducted according to OECD 405 and GLP (Safepharm Laboratories Ltd., 1987). Complete corneal opacity was recorded at 20 minutes in a single rabbit, with a Draize score of >=98/110 (see Table 5.4.1). Due to the severity of the reaction no further animals were tested.


Justification for selection of skin irritation / corrosion endpoint:
The selected study is the highest quality study available for skin corrosivity. It was conducted according to an appropriate OECD test guideline but not in compliance with GLP.

Justification for selection of eye irritation endpoint:
The selected study is the highest quality study available for eye corrosivity. It was conducted according to an appropriate OECD test guideline and in compliance with GLP.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

On the basis of the available skin irritation/corrosion and eye irritation studies, 3 -(diethoxymethylsilyl) propylamine is classified 'Skin Corr. 1B' with the hazard statement 'H314: Causes severe skin burns and eye damage' according to the criteria of Regulation (EC) No 1272/2008. It is assumed that substances that are corrosive to the skin are also damaging to the eyes, so there is no separate labelling for the eyes. There are no specific data for respiratory irritation/corrosion.