5-Diazo-2,4,6(1H, 3H, 5H)-pyrimidinetrione

Endpoint summary

Description of key information

In vitro investigations were performed to examine the the irritating or corrosive potential of Diazobarbitursäure. Under the condition of these tests methods Diazobarbitursäure proved to be neither corrosive nor  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)

Additional information

SKIN CORROSION

An in-vitro study for predicting non-specific, corrosive potential of Diazobarbitursäure by using reconstructed human skin (RHS) EST-1000 in accordance with OECD TG 431 and with an EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion). Diazobarbitursäurewas tested undissolved (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin). An incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation, the MTT reduction assay was performed to measure the cell viability which was 101 % and 98 % , respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used (Wingenroth 2012).

SKIN IRRITATION

The experiment was carried out according to OECD 439 and EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (Cell Systems, St.Katharinen, Germany).

Undissolved Diazobarbitursäure was applied topically to the RHS model, i.e. 30 mg per insert (plus 30µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates). After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 94 % (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay. The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model. Thus, the results show that Diazobarbitursäure is considered to have no skin irritation category. (Wingenroth 2012).

EYE IRRITATION

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2012. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undisolved Diazobarbitursäure was applied topically to the HCE tissue, i.e. 30 mg per insert (three replicates). After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 94.86 % as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control

(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that Diazobarbitursäure is predicted as non-irritant under the conditions of this test method (Bayer 2012).

Justification for classification or non-classification

According to the available test results no classification / labelling is required.