Registration Dossier

Administrative data

Description of key information

Not skin irritating
Not eye 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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Eight in vivo studies are available assessing skin irritation for 16090-02-1. Some of them were performed on a substance of good purity. All results are reported following a scoring system different from the European one, but for some of them the original report reported the tables, making possible to calculate the irritation score according to CLP Regulation. All studies are consistent and indicate no irritant effects for any of the samples.

Seven in vivo studies are available assessing eye irritation. Some of them were performed on a substance of good purity. In some cases the results are reported following a scoring system different from the European one, but for some of them the original raw tables are included, making possible to calculate the irritation score according to CLP Regulation. All studies are consistent and indicate no irritant effects for any of the samples.


Justification for selection of skin irritation / corrosion endpoint:
Test procedures does not follow an official European testing guideline, nevertheless are well documented and scientifically acceptable. The substance testes has an active ingredient of 83 %.

Justification for selection of eye irritation endpoint:
Test procedures does not follow an official European testing guideline, nevertheless are well documented and scientifically acceptable. The substance testes has an active ingredient of 83 %.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In all the studies available, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions. Also in the cases in which the reaction scores at 48 hours was not reported, the mean values scored are in all cases reasonably expected to be less than 2.3 for erythema/eschar and for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal.

According to the Regulation EC 1272/2008 (CLP) substances the have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

In all the studies presented the criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline, nevertheless the scoring system used to record the effects are the same of that reported into the OECD. Because the raw tables are included into the studies, it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008).

It has to be noted that there the timing for the removal of the substance in the studies reported is very different from that indicated into the OECD guideline (30 seconds in the current studies and 1 hours in the OECD); nevertheless, the mean values from gradings at 24, 48 and 72 hours for both rinsed and unrinsed eyes are lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals. Therefore the substance does not meet the criteria to be classified as eye irritating.

In conclusion, the available experimental data are adequate for classification and labelling.

The substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).