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Administrative data

Description of key information

Irritant to skin.

Not irritant to eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

THe target substance was tested for skin irritation potential on rabbit skin, following the Code of Federal Regulations, title 16, section 1500.41.

With respect to OECD guideline 404, such study protocol does not report a 48 -h observation time and involve a 24 -h test material exposure followed by observations at 24 and 72 h. Moreover, test material is patched both on abraded and intact skin of 6 rabbits. Calculations of mean scores were restricted to results obtained from intact skin.

The target substance was tested for eye irritation potential on rabbit eye, following the Code of Federal Regulations, title 16, section 1500.42.

Such protocol mainly differs from OECD guideline 405 in terms of number of rabbits, 6 instead of 3. Results were recorded at 24, 48, 72 h up to 8 d upon application.

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:

(1) 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

(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.

 

According to the Guidance on Application of the CLP Regulation (EC 1272/2008), available studies following other test methods than OECD guideline 404, can be used for thew purpose of classification. In case of 6 rabbits, if 4 of 6 rabbits show a mean score (calculated as average score per animal) of 2.3 or above, a skin irritant category 2 classification is assigned to test substance. Based on test results in terms of oedema, a classification in category 2 was applied.

 

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 case of 6 rabbits, classification in category 1 or 2 applies when 4/6 (instead of 2/3 rabbits) show effects on cornea, iris and conjunctivae above the threshold levels of the CLP Regulation (EC 12727/2008). As irritation scores of treated eyes were all below the thresholds, no classification applied.