Registration Dossier
Registration Dossier
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EC number: 248-374-6 | CAS number: 27253-32-3
Endpoint summary
Administrative data
Description of key information
No skin sensitisation study with manganese neodecanoate is available, thus the skin sensitisation potential will be addressed with existing data on the individual moieties manganese and neodecanoate.
Manganese neodecanoate is not expected to show signs of dermal sensitisation, since the two moieties manganese and neodecanoate have not shown any skin sensitisation potential in experimental testing.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Manganese
No classification of manganese is based on two negative LLNA studies on manganese chloride and upon lack of any sensitisation with a 75/80% MnSO4 solution (mixed with NiSO4) in human patch tests.
Neodecanoate
Neodecanoic acid has been examined for skin sensitization potential in the guinea pig maximization procedure of Magnusson and Kligman. Groups of ten male and ten female guinea pigs were used for the test and a further five males and five females as controls. Induction was accomplished in two stages.
1) Intradermal injection: Two rows of three injections were made, one on each side of the midline in the shorn skin of the shoulder region. 2) Topical application: One week after the intradermal injections, the same area was clipped free from hair. A 4x4 cm patch of filter paper was soaked in a solution of the test material and placed over the injection sites and covered with an occlusive dressing. The dressing was left in place for 48 hours. The challenge procedure was carried out two weeks after topical induction. Challenge was accomplished by topical application of the test material to the flank of animals via an occluded patch. The challenge lasted 24 hours. Immediately after the challenge, and then again at 24 and 48 hours later, each animals was examined for signs of skin sensitization. At no point was there any evidence of skin sensitization produced by neodecanoic acid.
Manganese neodecanoate
Manganese neodecanoate is not expected to show signs of dermal sensitisation, since the two moieties manganese and neodecanoate have not shown any skin sensitisation potential in experimental testing. Thus, manganese neodecanoate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Further testing is not required. For further information on the toxicity of the individual assessment entities, please refer to the relevant sections in the IUCLID and CSR.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Manganese neodecanoate is not expected to show signs of dermal sensitisation, since the two moieties manganese and neodecanoate have not shown any skin sensitisation potential in experimental testing. Thus, manganese neodecanoate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.
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