Registration Dossier

Administrative data

Description of key information

Melamine phosphate was found to be non irritating in a GLP-compliant in-vitro study with human reconsituted epidermis following EU method B.46 (BASF 2010). In a screening test with one rabbit (Pels Rijcken 1998), no effects were observed on iris and on cornea. The 24 - 72h average for the conjunctivae scores was 1.33 of max. 4. Conjunctivae findings were completely reversible within 7 days. For chemosis, the 24- 72h mean was 0.33 compared to a highest possible score of  3. 

Key value for chemical safety assessment

Additional information

No indication of skin irritation was observed in the in-vitro skin irritation study. The EU. method B.46 has been accepted to distinguish irritant and non irritant substances according to the dangerous substance directive (67/548/EEC). All acceptability criteria were met during performance of the assay. In the absence of any reduction in viability by the test item, no further in vivo testing is considered necessary.

Reversible effects on conjunctivae were observed in a screening study with one rabbit. This might be due to the slightly acid properties, as a saturated solution of 3.9 g/L shows a pH of 3.5. Conjuncitvae scores for redness were 1, 2, 1 and 1 at the 1h, 24h, 48h and 72h readings. Conjunctivae scores for chemosis were 2, 1, 0 and 0 at the 1h, 24h, 48h and 72h readings. No findings were observed at the 7 day reading.

These results are sufficiently below the threshold for classification as an irritant to eyes, therefore follow up testing with the three animals required by the OECD testing guideline is considered not justifiable. Currently available valid in-vitro studies can only distinguish between strong irritants and non irritants and would not contribute to the hazard assessment of melamine phosphate.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008.