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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation (OECD TG 404): the substance does not cause skin irritation.

Eye irritation (OECD TG 405): the substance does not cause eye irritation.

Respiratory irritation: the substance causes no respiratory irritation.

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 adverse effect observed (not irritating)

Additional information

Skin irritation


The substance was tested in a skin irritation test in female rabbits (OECD TG 404). New Zealand White rabbits were exposed to 0.5 mL of the substance for 4 hours in a semiocclusive manner. Very slight erythema, with or without very slight oedema was seen in two animals 24 and 48 hours after removal of the dressing. The observations were fully reversible within 72 hours. Average erythema and edema scores (24/48/72 hr) were 0, 0.67 and 0.67 and 0, 0.33 and 0.33, respectively. Based on these results, the substance does not cause skin irritation.


Eye irritation


The substance was tested in an in vivo acute eye irritation study (OECD TG 405). Three female rabbits were exposed to the substance for a duration of 1 hour using a single application of 0.1 mL. The treatment was followed by an observation period of 14 days. No corneal damage or iridial inflammation was observed. Conjunctival inflammation was observed in all three animals, but eyes had returned to normal three days after instillation. Average scores for conjunctival irritation (redness) were 0.67 for all animals over the 24/48/72 -hour observations. Iris, opacity and chemosis scores were 0 for all animals over the entire observation period. Based on these results, the substance is not an eye irritant.


Respiratory irritation


There are no occupational or consumer data indicating respiratory tract irritation. There are also no relevant experimental guidelines or results available that indicate respiratory irritation, therefore respiratory irritation is not anticipated. The ECHA guidance (R7a: 7.2.12.1, 2017) presents that respiratory irritation may be indicated when the substance is a severe irritant. Because the substance is not a skin or eye irritant it is not likely to be a respiratory irritant.

Justification for classification or non-classification

The substance does not have to be classified for skin, eye or respiratory irritation according to EU CLP (EC no. 1272/2008 and its amendments).