Registration Dossier

Administrative data

Description of key information

Elintaal F was tested in a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline. The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles.
Elintaal F was tested in an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline.
Based on this, Elintaal is considered skin irritating and not irritating to the eye.

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

Skin irritation:

Elintaal F was tested in a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline.

Elintaal F caused moderate skin irritation 48 hours after patch removal. Its dermal effects consisted of very slight or well-defined erythema, very slight ischemia, slight or distinct scaliness and very slight or slight edema.

As the observation period was limited to 48 hours after patch removal and no reversibility had been observed, an in vitro skin irritation study was performed.

In an in vitro skin irritation test using a human skin model ( EPISKIN Small Model), the influence of the test substance on the viability of human skin was tested. The test substance (25μl) was applied directly to 0.38 cm2cultured skin.

After 15 minutes, the substance was removed and cells were cultured for 42 hours. Elintaal was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that Elintaal did not interact with MTT.

The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 13% whereas the test substance showed cell viability of 25%. Since the mean relative tissue viability after exposure to the test substance was below 50%, it can be concluded that Elintaal is irritating in the in vitro skin irritation test.

Based on the in vivo study, it can be concluded that Elintaal is not corrosive. Based on the in vitro study, it can be concluded that Elintaal should be

classified as skin irritation cat.2 and should be labelled with H315: Causes skin irritation.

Eye irritation:

Elintaal F was tested in an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline.

The test substance caused slight redness of the conjunctivae in 3 out of 6 rabbits. The effects were fully reversible after 7 days. No effects on cornea, iris and chemosis were observed.

Based on the results, Elintaal F does not have to be classified.


Justification for selection of skin irritation / corrosion endpoint:
One in vivo and one in vitro study on the substance is available.

Justification for selection of eye irritation endpoint:
One in vivo study on the substance is available.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the results, Elintaal should be classified as skin irritation cat.2 and should be labelled with H315: Causes skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Elintaal does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.