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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

non skin irritating

non eye irritating

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

The skin irritation potential of the test substance was investigated by topical application of test substance of three young adult New Zealand rabbits. The study was conducted according to internationally accepted guidelines (OECD 404).

The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) was used in calculating the respective mean values for each type of lesion.

The results showed no skin irritation potential.

EYE IRRITATION

The eye irritation potential of the test substance was investigated by instillation the test substane into one eye of each of three young adult New Zealand rabbits. The study was conducted according to internationally accepted guidelines (OECD 405).

The treated eyes were not rinsed after substance application. Scoring of irritation effects were performed 1, 24, 48 and 72 hours after test article application.

The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The results showed no eye irritation potential.

Justification for classification or non-classification

According to regulation EC 1272/2008 (CLP) the test substance is not classified as both skin and eyes irritant, since the calculated mean scores were all below the limits of classification.

 

In detail, for skin irritation the individual mean scores at 24, 48 and 72 hours for 3/3 animals were below the value of 2.3 for both erythema and edema, which is the limit for classification. The effects were fully reversible.

For eye irritation, the individual mean score at 24, 48 and 72 hours for 3/3 animals for cornea, iris, conjunctivae and chemosis were all below the limit values required for classification, respectively 1, 1, 2, 2. The effects were fully reversible.

For the abovementioned reason, the test substance is not classified neither as skin, nor as eye irritation.