Registration Dossier

Administrative data

Description of key information

In vitro skin irritation: not irritant

In vivo eye irritation: not irritant

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 potential of the target substance was tested in vitro according to OECD Guideline 439. Average viability was 90.3 % of negative control, thus outside the range of classification, i.e. viability lower or equal to 50 % of control.

Eye irritation potential of target substance was assessed by two in vitro studies.

In the HET-CAM assay, test substance caused no irritation to CAM fertilised chicken eggs. According to ECHA Chapter R7a: endpoint specific guidance (v. 5.0), this method has currently limited application under REACH. Moreover, it does not allow a definite conclusion on classification. Indeed a negative result excludes a eye damage potential but may not exclude an irritation potential.

In the NRU assay, the substance resulted as non-irritant. However, such method is not reported in the ECHA chapter R7a.

Overall, such studies were considered as not sufficient or not suitable to assess the eye irritation potential of the target substance, due to the following reasons:

- lack of testing guidelines for both the methods

- limited relevance within the REACH Regulation (EC 1907/2006)

- no available interpretation of results for classification under CLP Regulation (EC 1272/2008) in case of NRU assay.

Therefore, they were only used as a qualitative indication of low eye irritation potential and a read across approach was adopted to complete the assesment.

Available data on Similar Substance 01 was used due to the high structural similarity between target and read across susbtances. The read across justification is provided in section 13.

An in vivo study (2004), according to OECD guideline 405, was chosen as key study, as well conducted and described in details. Instillation of Similar Substance 01 in the eye of 3 rabbits, showed slight effects in terms of corneal opacity, conjunctivae redness and chemosis, which were fully reversible by the end of the 7 -days observation period.

Such result was confirmed by an in vivo study (1978), reporting a slight effect on cornea in 1/6 rabbits. Such effect was reversible within 8 days.

Justification for classification or non-classification

Skin Irritation

According to ECHA Chapter R.7a (v. 5.0), test method described in OECD guideline 439 is validated and accepted under the REACH Regulation (EC 1907/2006).

In reference to the CLP Regulation (EC 1272/2008), test substance may be considered as:

- non irritant to skin, if tissue viability after exposure and post-treatment incubation period is > 50 %,

- category 2 or category 1, if the mean percent tissue viability after exposure and post-treatmen incubation is ≤ to 50 %. Since this method cannot resolve between categories 1 and 2, further information on skin corrosion will be required to decide on the final classification.

 

Based on test results, no classification applied. the substance 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.

Based on test results, no classification applied: the substance was considered as non irritant to eye.