Registration Dossier

Administrative data

Description of key information

Based on the observed results it was concluded, that N-Methyldiisopropanolamin shows a corrosive potential in the EpiDerm™ skin corrosion/irritation test. [BASF, 2012]

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

Additional information

skin irritation

The potential of N-Methyldiisopropanolamin to cause dermal corrosion/irritation was assessed by a single topical application of 50 μL (corrosion test) or 30 μL (irritation test) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by an about 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiDerm™ skin corrosivity/irritation test showed the following results: The test substance is able to reduce MTT directly. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing (performed with corrosion test, only).

corrosion test:

The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 74%, and it was 11% after an exposure period of 1 hour.

irritation test:

The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 6%.


Justification for selection of eye irritation endpoint:
In accordance with column 2 of REACH Annex VII, the test on eye irritation (required in section 8.2) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, further testing is scientifically unjustified.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the results obtained in an in vitro skin irritation study, the test substance has to be classified with respect to skin irritation, C, R34, "Corrosive; causes burns" according to Directive 67/548/EEC (DSD) and cat. 1B, H314 "Causes severe skin burns and eye damage" according to Regulation (EC) No 1272/2008 (CLP, GHS).