Registration Dossier

Administrative data

Description of key information

Skin irritation: non irritant

Eye irritation: irritant with irreversible effects

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:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin Irritation

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

A substance has to be classified as category 1 (corrosive) if it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration.

 

A substance has to be classified as category 2 (irritant) if shows:

- 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 or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

In available studies, based on older test methods, 6 rabbits were used. The current UN Criteria (June 2011) should be applied. In case of 6 rabbits the following applies:

a. classification as skin corrosive – Category 1 if destruction of skin tissue (visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours.

b. classification as skin irritation – Category 2 if at least 4 out of 6 rabbits show a mean score per animal of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema

Under test conditions, no sign of irritation was observed upon application of test substances, thus no classification applied to the substance and it was considered as non irritant to skin.

 

Eye Irritation

According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application .

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.

 

A substance has to be classified as category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 3 and/or

- iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

 

A substance has to be classified as category 2 (irritating to eye) 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 available studies, based on older test methods, 6 rabbits were used. The current UN Criteria (June 2011) should be applied. In case of 6 rabbits the following applies:

a. classification as serious eye damage – Category 1 if:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or

- at least 4 out of 6 rabbits show a mean score per animal of ≥ 3 for corneal opacity and/or > 1.5 for iritis

b. classification as eye irritation – Category 2 if at least 4 out of 6 rabbits show a mean score per animal of:

- ≥ 1 for corneal opacity and/or

- ≥ 1 for iritis and/or

- ≥ 2 conjunctival erythema (redness) and/or

- ≥ 2 conjunctival oedema (swelling) (chemosis) and which fully reverses within an observation period of normally 21 days.

Based on available experimental data, the substance is classified in category 1 (H318) for irreversible effects on eye.