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

SKIN IRRITATION

The skin irritation potential was assessed following the procedure of the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Primary irritation index was estimated to be between 0.6 and 1.2 as a range from four different assay that set the substance as mild irritating.

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results, because the raw tables are included into the study report.

Despite the reaction scores at 48 hours were not reported, the mean value scored is reasonably expected to be less than 2.3 for erythema/eschar and for oedema in at least 2 of 3 tested animals, in both intact and abraded skin, from gradings at 24, 48 and 72 hours after patch removal.

In conclusion, the substance is not classified as skin irritant according to the CLP Regulation (EC 1272/2008) (Ciba-Geigy Ltd., 1975).

 

Further three studies are available on the substance under registration (CAS 13963-31-5) and all confirm the outcomes of the key study.

EYE IRRITATION

The eye irritation potential was assessed following the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Four reports were presented.

In the key study, where the substance tested has the highest purity (> 80 %) the irritation index was established as 2.8 for the cornea, 0 for the iris and 2.7 for the conjunctivae; minimum irritating.

The scoring system used for the cornea opacity and degree of density, for the iris and conjunctivae redness and chemosis is the same of that reported into the OECD, but the calculation of results for the evaluation of the eye irritation potential followed in the test is different from that reported into the OECD guideline. The raw tables are not included into the study report, thus the scores related to the reactions of the unrinsed eye cannot be re-evaluated according to the CLP Regulation (EC 1272/2008).

Despite also the timing for the removal of the substance is very different between AFDO and OECD (30 seconds in this experiment and 1 hours in the OECD), the results clearly indicate that the mean values from gradings at 24, 48 and 72 hours for rinsed eyes were 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 is not classified as irritating for the eye according to the CLP Regulation (EC 1272/2008) (Ciba-Geigy Ltd., 1975).

 

All the further three studies reported confirm the outcomes of the key study.


Justification for selection of skin irritation / corrosion endpoint:
Test conducted according to internationally accepted testing guidelines. Test substance purity > 80 %

Justification for selection of eye irritation endpoint:
Test conducted according to internationally accepted testing guidelines. Test substance purity > 80 %

Justification for classification or non-classification

According to 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.

According to the Regulation 1272/2008 (CLP), substances 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.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.

In conclusion, the available experimental data is adequate for classification and labelling and the substance is not classified for the eye and skin irritation, according to the CLP Regulation (EC 1272/2008).