Registration Dossier

Administrative data

Description of key information

Skin irritation : two guideline study (OECD 404) were available in rabbits.
Eye irritation : a guideline study (OECD 405) was available in rabbits.

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)

Additional information

Skin irritation :

One Acute Dermal Irritation / Corrosion GLP test performed according to OECD 404 was carried out with DOT(2 -EHMA) (purity>98%). The test substance was applied undiluted on a patch on shaved rabbit skin. The test material induced slight to moderate erythema on all rabbits and very slight edema on four animals. Three rabbits had desquamation. There were no other dermal findings. All irritations were reversible and completely subsided at day 11 or earlier.

The Primary Irritation Index was calculated to be 2.2.Under the experimental conditions, the test substance was classified as a moderately irritant.

Eye irritation :

One in vivo rabbit eye irritation GLP study performed according to OECD 405 was carried out with DOT(2 -EHMA) (purity>98%). The test substance was instilled undiluted in the right lower conjunctival sac. Minor conjunctival irritation was observed, and no iris or corneal effects. Effects were fully reversible within 96h. The test substance was not considered as an eye irritant.


Effects on skin irritation/corrosion: moderately irritating

Justification for classification or non-classification

Skin irritation :

According to Directive 67/548/EEC, DOT(2 -EHMA) is classified as R38 'Irritating to skin'.

Justification : There are 5/6 rabbits with a erythema score of 2 or more (mean values of 24, 48 and 72 hours). None of 6/6 rabbits have edema score of 2 or more. All effects were fully reversible.

According to Regulation EC no.1272/2008 (CLP), DOT(2 -EHMA) is not classified as skin irritant.

Justification : There are only 1 rabbit with a erythema score of 2.3 or more (mean values of 24,48 and 72 hours). None of 6 rabbits have a edema score of 2.3 or more. All effects were fully reversible.

Eye irritation:

Based on the results of the key study for eye irritation, DOT(2 -EHMA) is not classified for eye irritation according to Regulation EC no.1272/2008 (CLP) and according to Directive 67/548/EEC.