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

No studies on "Irritation/Corrosion" are available for the substance in itself, nevertheless studies conducted with an analogue molecule (Similar Substance 01) were taken into account in order to complete the assessment. Further information are reported in the Read Across justification attached to section 13.

SKIN IRRITATION

The skin irritation potential of the test substance was evaluated on the bases of three studies carried out on Similar Substance 01 (further information are reported in the Read Across justification attached to section 13).

The first study (Huntsman, 1977) was performed according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics by The Association of Food & Drug Officials of the United States (1959)".

Despite the reaction scores at 48 hours were not reported, the 24 and 72 hours values for all the animals was recorded as 0, thus it is reasonable to consider 0 the values at 48 hours.

The substance was concluded to be not an irritant for the rabbit skin.

The second study (Huntsman, 1984) was performed according to OECD guideline 404. This study confirms the outcomes of the key study. The third study (Huntsman, 1974) was performed following Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191.11). This study concluded that the substance is "mildly irritating" to rabbit skin. Considering that the score and classification system are different from the CLP Regulation one; considering that the study uses the values obtained also from abraded skin; considering that for only 2 animals on 6 were recorded an oedema score of 1 at 24 hours and, an erythema and oedema scores of 1 at 72 hours. It can be assumed that the substance is non irritant and not corrosive for skin.

EYE IRRITATION

The eye irritation potential of the test substance was evaluated on the basis of three studies carried out on Similar Substance 01, and of one more study conducted on Similar Substance 02 (further information are reported in the Read Across justification attached to section 13).

The first study (Huntsman, 1984) was conducted according to OECD 405. All the effects observed in the rabbits were reversible in 7 days. According to the CLP Regulation (EC 1272/2008) the conjunctiva scores for 2 of 3 animals calculated in this study fulfill the criteria for Category 2 classification for eye irritation.

The second study (Huntsman, 1977) was performed according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). 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. Nevertheless, the iris and cornea scores for all the rabbits were 0; only the conjunctiva scores was above the 0 value but the effects were fully reversible within 7 days. Therefore the test item can cause a minimal irritation to rabbits.

The third study (Huntsman, 1974) was conducted according to The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191.12). As for the second study mentioned above the calculation of results for the evaluation of the eye irritation potential differs from that reported in the OECD guideline. Therefore the iris score for all the animals was 0 and only for 1 animal on 6 the cornea score was above 0, with full reversibility of the effect within 3 days. The effects on conjunctiva differed among the animals tested: some rabbits were scored with 0 while other rabbits were scored with a value indicating effect on conjunctiva; however these effect were fully reversible within 7 days.

In the study carried out with the Similar Substance 02, the substance was tested for its eye irritation potential according to the Code of Federal Regulations, Title 16, Section 1500.42

100 µL of the test item was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The treated eyes were examined 24, 48 and 72 hours and 8 days after application of the test substance. At 8 days the eyes were also examined for corneal lesions under UV light after instillation of one drop of fluorescein. No irritant effects were observed, hence the test substance is considered to be not irritating to the eye.

Justification for classification or non-classification

SKIN IRRITATION

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 the studies available, the substance did not show a potential to be skin irritant.

Considering the available data, the substance can be considered as not classified for skin irritation.

EYE IRRITATION

According to the CLP Regulation (EC 1272/2008) substances that 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 two of the studies conducted on the Similar Substance 01, the substance does not show ocular effects that can give a warning for eye irritation nevertheless, they can't be used for the classification pourpose because the report results were calculated according to a different scoring criteria. Anyway, only conjunctiva was affected, and the symptoms related were reversible in a few days.

In the third study the eye irritation was evaluated using a substance with a low purity (28%) moreover, the treated eyes haven't been rinsed after the application of the substance.

In order to give a complete assessment of the eye irritationpotential of the substance, another study conducted on Similar Substance 02 was taken into account. During the study no ocular effects were obserbed.

Considering the available data and the consideration above the substance can be considered as not classified for Eye irritation according to the CLP Regulation