Registration Dossier

Administrative data

Description of key information

Skin: not irritating, not corrosive
Eye: not irritating, not corrosive

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/corrosion

A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit on a Similar substance 01.. The method followed OECD Guidelines 404 and Method B4 of Commission Directive 92/69/EEC. Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.

The Similar substance 02 was tested for skin irritation according to the Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation.

All lesions observed were all completely reversible maximum in 72 hours and one animal does not show any irritating effects. The tested substance is not considered as skin irritant.

Similar substance 01 and Similar substance 02 are not skin irritant.

Based on the read-across principle, the results can be considered for the assessment of the registered substance.

Justification for read-across is detailed in the report attached to the IUCLID section 13.

Eye irritation/corrosion

A study was performed to assess the irritation of the Similar substance 01 to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5 of Commission Directive 92/69/EEC.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

The Similar substance 02 was tested for eye irritation according to the Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation. Based on test results, the susbtance needs to be considered as eye irritant.

Similar substance 01 is not an eye irritant and Similar substance 02 is an eye irritant.

According to the details of the available study, the Similar substance 01 OECD405 study is considered more appropriate for the evaluation of the CLP classification of the registered substance and it has been considered a key study.

Justification for read-across is detailed in the report attached to the IUCLID section 13.


Justification for classification or non-classification

Skin irritation/corrosion

Substances that have the potential to induce reversible skin irritation are classified in Category 2 (irritating to skin).

According to the CLP Regulation 1272/2008, the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.2, table 3.2.2.

If, when applied to the skin of an animal, the substance produces:

(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from grading 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

(2) 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

(3) 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. Reversibility of skin lesions is the other decisive factor in evaluating responses in the animal test.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.

Eye irritation/corrosion

Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).

According to the CLP Regulation 1272/2008, using the results of animal testing the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.3, table 3.3.2

If, when applied to the eye of an animal, the 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

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.