Registration Dossier

Administrative data

Description of key information

Non-sensitiser based on weight of evidence.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Across 4 studies utilising the read across substance MnCl2 or MnSO4/NiSO4 in animals or humans, there was no evidence of skin sensitisation, (either with MgCl2 specifically in LLNAs by Basketter et al., and Ikarashi et al., or human patch tests with MnCl2 or MnSO4/NiSO4 by Santucci et al., and Menezes et al).


Justification for selection of skin sensitisation endpoint:
Study with MnCl2, consistent with the LLNA OECD guideline, although no claim of GLP compliance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification is based upon read-across of two negative LLNA studies on manganese chloride (IUCLID section 7.4.1, Basketter et al and Ikarashi et al ) and upon lack of any sensitisation with a 75/80% MnSO4 solution (mixed with NiSO4) in human patch tests (IUCLID section 7.4.1., Santucci et al). Read across from MnCl2 to MnSO4 is justified because both have Mn2+ ion present, but in the case of MnCl2, there is evidence of greater absorption via the oral route (IUCLID section 8.8.1 Bales et al., 1987) and supported by the relative acute oral toxicity of these substances. Therefore the negative result would also be expected from MnSO4, as the sulphate ion is also not a sensitising entity.