Registration Dossier

Administrative data

Description of key information

No studies are available with diphosphoric acid, compound with 1,3,5 -triazine-2,4,6 -triamine (1:2). However, reliable data are available for the structrual analogue substance 1,3,5 -triazine-2,4,6 -triamine (melamine, CAS 108 -78 -1).

OECD 406: not skin sensitising

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:
refer to analogue justification provided in IUCLID section 13
Reason / purpose:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% induction, 50% challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No positive skin reaction in any animal at any reading time
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% induction, 50% challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No positive skin reaction in any animal at any reading time
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% induction and challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No positive skin reaction in any animal at any reading time
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% induction and challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No positive skin reaction in any animal at any reading time
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Remarks:
checked separately, twice a year
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification is required according to Regulations (EC) No 1272/2008.
Conclusions:
A reliable GPMT test according to OECD 406 and in compliance with GLP is available for the source substance melamine. No indication of skin sensitisation was observed under the conditions of this test. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin sensitising potential and thus no skin sensitising potential is considered for the target substance as well.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no data available on skin sensitisation of diphosphoric acid, compound with 1,3,5 -triazine-2,4,6 -triamine (CAS 13518 -93 -9). In order to fulfil the standard information requirements set out in Annex VII, 8.3., in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

A reliable skin sensitisation study according to OECD 406 and GLP is available with the source substance 1,3,5-triazine-2,4,6-triamine (melamine, CAS 108-78-1) (Seibersdorf, 2010). The study was performed in two consecutive steps: In the first step 5 control and 10 test substance animals were used and as after the challenge exposure negative results were obtained, additional 5 control animals and 10 test substance animals were exposed. The administered test substance concentrations were derived from the results of a preliminary test. Two induction exposures were performed with a one week interval. First induction exposure: Intracutaneous injection of Freund´s complete adjuvant emulsified with isotonic saline (1:1) and epicutaneous administration of the test substance (50% in white petrolatum). Second induction exposure: Preceded by a topical application of 10% Na-dodecylsulfate in petrolatum for erythema induction 24 h before the epicutaneous administration of the test substance (50% in white petrolatum). Control animals were given plain white petrolatum at both inductions. Challenge exposure: Two weeks after the second induction exposure. Epicutaneous administration of the test substance (50% in white petrolatum) and the vehicle (white petrolatum), identical for the test substance group and the negative control group. For the epicutaneous exposures occlusive dressings were used. At challenge exposure the control sites of all animals of both groups were normal at each reading time. After the challenge exposures, no animal of the test substance group had positive skin reactions at the test substance treated sites 24 hours and/or 48 hours after the end of the exposure. No adverse skin reactions were observed in the control animals. Therefore, no animal of the test substance group was regarded as sensitised. In a positive control with hexyl cinnamic aldehyde 50% of the animals showed positive reaction, showing the validity of the test.

Based on the above study results with the structural analogue substances melamine (CAS 108-78-1) sufficient evidence is given that the registered substance diphoshoric acid, compound with 1,3,5-triazine-2,4,6-triamine 1:2 (CAS 13518-93-9) is considered not to have skin sensitising potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data with a source substance on skin sensitisation do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.