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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In the available skin and eye irritation/ corrosion studies in rabbits performed according to OECD Guidelines 404 and 405 respectively, the test substance Urea 4 showed no irritation/ corrosion effects.

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

An in vitro skin irritation was not conducted because adequate data from an in vivo skin irritation study are available.

The test substance Urea 4 was tested for its irritation/ corrosion properties in a study performed according to EU Method B.4, OECD Guideline 404 and EPA OPPTS 870.2500. The test substance was applied to one site of the clipped back of 3 rabbits at a dose of 0.5 g per application site while the untreated side served as control. The application site was covered with a semi - occlusive bandage for a 4 hour - contact/ exposure time. Observations were recorded and compared to the control sites, 1, 24, 48 and 72 hours after removal of the patch. The test item showed no irritant/ corrosive effects on the intact skin within 72 hours after removal of the test item. No other clinical signs of toxicity were observed. Under the conditions of the study, the test substance was considered to have no irritation/corrosive properties.

Eye

An in vitro eye irritation was not conducted because adequate data from an in vivo eye irritation study are available.

The test item Urea 4 was tested for its eye irritation/ corrosion properties according to EU Method B.5, OECD Guideline 405 and EPA OPPTS 870.2400. In the available study the test item was applied to the lower conjunctival sac of one eye of 3 rabbits at a dose of 0.1 g per application site and it was not rinsed thereafter. The untreated eye served as control. Observations were calculated and compared to controls 1, 24, 48 and 72 hours after application of the test item. Application of the test item caused minimal blepharospasm in all animals immediately after application and 1 hour after application a slight erythema of the conjunctivae was visible. No signs of irritation were visible at the 24 hours reading in all of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. For all three animals, the mean cornea and iris scores were 0 and the conjunctivae scores for redness and chemosis were 0.78. No corrosion effect were observed. Under the study conditions the test item was considered to have no irritation and no corrosive effects to eyes of rabbits.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline conform study

Justification for selection of eye irritation endpoint:
GLP and guideline conform study

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


Based on the available experimental test data, the test substance is not considered to be classified for skin irritation/corrosion or eye irritation under Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.