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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The skin irritation/corrosion study was performed following EPA: Toxic substances Guidelines, HG- organ/tissue- dermal irritation. 1987.
3 male and 3 female New Zealand White rabbits were treated with 0.5 g of test item for 4 hours.
The eye irritation was investigate with an in vitro study and an in vivo study. The in vivo study, performed in GLP and in accordance with OECD Guidelin no. 405, was preferred and selected as key study.
3 New Zealand White rabbits were treated with 0.1 ml (0.056 g; density determined to be 0.56kg/l) of test item for 7 days.

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 test article when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered non irritant for the skin.

The test article when tested for acute eye irritating properties in rabbits under the experimental conditions adopted, is to be considered non irritant for the eye. One rabbit showed severe eye effects, but these effects were attributed to the remnants remained present for up to 24 hours after treatment.

Justification for classification or non-classification

Basing on the results above reported, REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) would indicate the following:

 

Skin irritation

Classification : not classified

Signal word : -

Hazard statement : -

 

Eye irritation

Classification : Not classified

Signal word : -

Hazard statement : -