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Description of key information

Skin: Melamine was not sensitising in a GLP-compliant guinea pig maximisation test according to OECD guideline 406.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For Read Across Justification please refer to section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
FCA, white petrolatum
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No positive skin reaction in any animal at any reading time
Remarks on result:
other: CAS 108-78-1
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
TS, 50 % (w/w) in white petrolatum
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No positive skin reaction in any animal at any reading time
Remarks on result:
other: CAS 108-78-1
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
FCA & TS, 50 % (w/w) in white petrolatum
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No positive skin reaction in any animal at any reading time
Remarks on result:
other: CAS 108-78-1
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
TS, 50 % (w/w) in white petrolatum
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No positive skin reaction in any animal at any reading time
Remarks on result:
other: CAS 108-78-1
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: CAS 108-78-1
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: CAS 108-78-1
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin

There is no study available with melamine phosphate but with melamine. Both melamine and melamine phosphate are soluble in water and have a similar log Pow. Melamine was tested for sensitizing properties in guinea pigs. The guinea pig maximization test was performed according to OECD guideline 406 and following the principles of GLP. None of the animals were sensitized with the highest dose that could be applied (50% in white petrolatum for epicutaneous application) (DMS Melamine SL-LT-204/10; 2010).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EU) No. 2020/217.