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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: non-irritant
Eye irritation: non-irritant

Key value for chemical safety assessment

Additional information

The substance was tested for skin irritation potential using the patch test technique described in the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.41.

In the test report, skin reaction scores at 0 h and 72 h after patch removal are given. For the purposes of calculating erythema and oedema scores at non-given time points (after patch removal), the following is done: - scores at 24 h are taken also as scores at 48 h. The mean skin reaction scores are calculated from values at 24, 48 and 72 h after patch removal.

Intact and abraded skin showed no skin reactions at all for oedema; 2/6 rabbits show very slight edema at 24h, but this skin reactions were reversible within 72h.

For all animals, the calculation of mean skin reaction scores (24, 48 and 72 h) after patch removal gave the following values for intact skin: erythema score abraded and intact skin <1 and oedema score = 0 for abraded and intact skin.

Therefore, the test substance is a non-skin irritant.


In order to assess the eye irritation potential of the substance two test as weight of evidence were used.

The first test was available on disperse yellow 64.

The substance was tested for eye irritation potential according to the technique described in the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.42.

78 mg of test substance was instilled into one eye of each animal, the other eye remaining untreated, served as control.

Eye reactions were scored at 1 d, 2 d, 3 d, and 7 d after exposure.

In two animals at day 7 slight effect on redness was still present.

 The mean irritation indexes (at 1, 2 and 3 d) were the following:

Corneal score: (5/6)=0; 1/6 =1

iris score (6/6) = 0.

conjunctivae score (6/6) <2

chemosis (6/6) < 2

The test substance can be considered a non-eye irritant.

Anyway as the test ends at day 7 it is not possible to see the irreversible effect until day 21 and in two animals at day 7 there was still a slight effect on redness.

Therefore another test on similar substance 1 was used as Weight of evidence in order to support the non-classification for eye in the substance.


This test was performed according to OECD 405 and GLP. Each of 3 female rabbits received instillations of about 30 mg test substance into the conjunctival sac of the right eye; the respective left eye remained untreated and served as control. The eyes of the animals were observed 1, 24, 48 and 72 hours post application. Additionally, 24 hours post application the eyes were treated with fluorescein and examined . The scoring was done according to Draize. In none of the animals eyes were affected by treatment. The substance was evaluated to be non-irritating to the eyes of rabbits.

Therefore, also similar substance 1 is considered as a non-eye irritant.

Justification for classification or non-classification

For skin irritation and eye irritation, the CLP Regulation (EC 1272/2008) was used for overall judgment.

In the CLP Regulation (EC 1272/2008), skin irritation is defined as "the production of reversible damage to the skin following the application of a test substance for up to 4 hours." The same regulation, defines a Category 2 skin irritant as "Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal."

Therefore, the test substance is a non-skin irritant.

Moreover the CLP Regulation (EC 1272/2008), defines eye irritation as follows: "Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application." The same regulation defines a Category 2 eye irritant as, "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 gradings at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days."

Therefore, based on these results, the test material is considered as a non-eye irritant.