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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

The skin irritation potential of the test item on Reconstructed Human Epidermis (RHE SkinEthic) was investigating according to the OECD Guideline 439 in triplicates. The test item, under the conditions of the test, showed a mean cell survival of 106.74% (±5.10) and therefore it resulted to be non skin irritant as its cell viability is higher than 50%. All the acceptance criteria were passed.

The eye irritation potential of the test item was evaluated according to the OECD Guideline 492. Two runs with three replicates each have been performed because of borderline results (non-concordant replicate measurement) in the first run. The test item showed a mean cell survival of 66.5% (±13.5) in the first run and 82.2% (±9.3) in the second run, so it resulted to be not an eye irritant because its cell viability is higher than 60% . All the acceptance criteria were passed.

Justification for classification or non-classification

Skin irritation:

Under the conditions of the test performed according to the OECD Guideline 439, the mean cell viability was higher than 50 % for the reconstructed tissues treated with the test item. Therefore, the test item shall not be classified as skin irritant according to the CLP Regulation (EC) No. 1272/2008.

 

Eye irritation:

Under the conditions of the test performed according to the OECD Guideline 492, the mean cell viability was higher than 60 % for the reconstructed tissues treated with the test item. Therefore, the test item shall not be classified as eye irritant according to the CLP Regulation (EC) No. 1272/2008.