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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation (OECD 404): corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A skin irritation test is available with N-[3-(methoxydimethylsilyl)propyl]ethylenediamine (CAS 3069-33-8), which was performed in Himalayan rabbits according to OECD 404 and in compliance with GLP (LPT, 2002). Pure test substance (0.5 ml) was applied to a 6 cm² application site (shaved) for 4 h under semi-occlusive conditions. No residual test substance had to be removed. Sixty minutes and 24, 48, 72 h after patch removal the application site was examined. Erythema grade 3 was observed in all 3 animals from 60 min to 14 days after exposure. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch. Oedema reactions were fully reversible within 24 h in all 3 animals. A pale yellow or light-red bordered application site was observed in all animals 24 h after exposure until the end of the 14 day observation period. Necrosis at the application site was observed after 72 h (2/3 animals) or 4 days (1/3 animals) after patch removal. Peeling of the application site was observed in 2/3 animals after 14 days. No systemic effects were reported.

In conclusion, N-[3-(methoxydimethylsilyl)propyl]ethylenediamine was corrosive to the skin under the conditions of the test.

In accordance with Column 2 of REACH Annex VII, an eye irritation study (required in Section 8.3 of REACH Annex VII) needs not to be conducted as the substance is classified as corrosive to the skin, which implicits severe damage to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
The reliable GLP compliant OECD Guideline study was choosen.

Justification for selection of eye irritation endpoint:
In accordance with Column 2 of REACH Annex VII, an eye irritation study (required in Section 8.3 of REACH Annex VII) needs not to be conducted asthe substance is classified as corrosive to the skin, which implicits severe damage to the eyes.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The available data on skin and eye irritation/corrosion of the test substance meet the criteria for classification as “Skin corrosion 1B” and “Eye damage 1” with the hazard statement “Causes severe skin burns and eye damage (H314)” according to Regulation (EC) 1272/2008 and as “Corrosive, Causes burns (R34)” according to Directive 67/548/EEC. Cat 1B for corrosion according to Regulation (EC) 1272/2008 was chosen based on a worst case assumption as no data were available for a 1 h treatment and thus no differentiation between category 1B and 1C was possible.