Registration Dossier

Administrative data

Description of key information

- Acute Dermal Irritation/Corrosion:
In vivo skin irritation test (similar to OECD 404): not irritating.


- Acute Eye Irritation:
In vivo eye irritation test (similar to OECD 405): not irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Acute Dermal Irritation/Corrosion:

In the key skin irritation and corrosion study, IDDPP was found not to be irritating or corrosive to the skin when treated on the intact and abraded skin of albino rabbits. The average mean scores calculated from the numerical values given to the skin irritation observed at the 4, 24, and 48 hour examinations were 0.84 for erythema and 0.22 for edema.

In the additional 3 supporting skin irritation/corrosion studies the test substance was also not irritating to the rabbit and human skin.

Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), the test substance was considered not irritating and does not have to be classified and has no obligatory labelling requirement for skin irritation.

Acute Eye Irritation:

In the key eye irritation test the guidelines described by Draize (1965) were used to assign numerical scores for corneal, iridic and conjunctival irritation (redness/chemosis/discharge) to the observed effects and to develop a weighted total score for each rabbit for each day of observations. The mean scoring results was < 1.00 for all 9 rabbits. IDDPP was considered a non-irritant in the eyes of albino rabbits.

In the supporting eye irritation study the average maximum score was 21.3, 17.6, and 8.0 out of a possible 110 in 24, 48, and 72 hours, resp. Effects were completely reversible within 7 days. Interpretation of these results and classification of the test substance was not possible, since the scoring system used is not according to OECD guideline 405 or EU classification criteria. In the report it is concluded that IDDPP is mildly irritating to the eye.

Based on the results of the key study and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation.

The respiratory irritation was not studied for IDDPP.

Justification for classification or non-classification

The 2 key in vivo studies indicate that IDDPP does not induce any significant irritation to the skin and eye. Therefore, it can be concluded that the substance is not irritating and therefore does not need to be classified as such according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.