Registration Dossier

Administrative data

Description of key information

eye corrosion (BCOP, OECD 437): not corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

UMA121 was investigated in an acute dermal toxicity study performed according to OECD 402 and GLP (Chapter 7.2.3, Takawale, 2012). For acute dermal toxicity, a LD50 value > 2000 mg/kg bw was determined. No erythema or edema formation was observed during the 14 d observation period. In 1/5 males, eschar formation was observed on Day 8, that resolved within 24 h. In 4/5 females, scratches, eschar formation or wounds were noticed which were fully reversible within the observation period in 3/5 females.

In accordance with Regulation (EC) No 1907/2006 column 2 of Annex VIII Section 8.1.1., as an acute dermal toxicity study does not indicate skin irritation up to the limit dose level of 2000 mg/kg bw, an in vivo skin irritation study does not need to be conducted.

Eye irritation/corrosion

There is no data available addressing the eye irritation properties of UMA121. Based on a Bovine Corneal Opacity and Permeability Assay (BCOP) performed according to OECD 437, UMA121, which was ground to a fine powder to allow application, is considered to be non-corrosive (IVIS = 3.68) (Luetkenhaus, 2012).

UMA121 is a non-volatile resin, which is poorly soluble in water. The substance is not used in spraying, drilling or grinding applications.

In industrial and professional applications, exposure of the eyes is adequately controlled by personal protective equipment and standard hygiene measures in combination with the physical state of the substance. Non-professionals, such as the general population, are not exposed to UMA121.

No eye irritation test was performed on UMA121 in accordance with Regulation (EC) No. 1907/2006, which specifies that unnecessary tests should be avoided in terms of animal welfare.

Justification for classification or non-classification

The available data on skin and eye irritation/corrosion of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.