Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Not irritating to the skin.


Not irritating to eyes.

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

No studies on "irritation/corrosion" are available for the Target Substance, therefore information on Similar Substance 01 and 03 have taken into account for the assessment. Details on the similarity between the Target Substance and the Similar Substances are reported in section 3.


 


Skin Irritation:


Two studies were considered in order to complete the assessment on skin irritation: one test was conducted on Similar Substance 01 nevertheless few information is available regarding the method and the experimental results. Therefore, another test conducted on the Similar Substance 02 was considered in order to confirm the results of the first test.


The two results are consistent (both not irritant) and the substance is expected to be not irritant.


 


Eye Irritation:


Two studies were considered in order to complete the assessment on eye irritation: two tests were conducted on the Similar Substance 01 nevertheless few information is available regarding the methods and the experimental results.


All the results are consistent (both not irritant) and the substance is expected to be not irritant.

Justification for classification or non-classification

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


The available studies did not show any adverse effect onto skin of treated animals.


 


According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) 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.


From the available studies, it can be concluded that the substance is not eye irritant.


 


In summary, for both skin and eye irritation, the substance does not meet the criteria for classification under the CLP Regulation (EC n. 1272/2008).