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Toxicological information

Endpoint summary

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Description of key information

Read-across from soluble cobalt substances (i.e., cobalt dichloride and cobalt sulfate) and sodium sulfamate to cobalt(2 +) disulfamate is performed. A detailed documentation on read-across is attached on IUCLID section 13 (CoSulf_Read Across Assessment Framework Report).

Sodium sulfamate:

Based on the findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Regulation (EC) No 1272/2008, Sodium Sulphamate, does not possess a skin sensitisation potential.

Soluble cobalt substances *:

Cobalt dichloride and cobalt sulfate were identified as skin sensitisers in animal studies (guinea pig maximisation test and adjuvant and patch test, respectively) and cobalt dichloride was identified as a skin sensitiser in human observations (largely studies with volunteers).

Reference: * SIAR, 2014:

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

For soluble cobalt substances studies in humans are available which are included in IUCLID secion 7.10.4 and discussed in endpoint summary IUCLID section 7.4 "Co_Sensitisation".

Justification for classification or non-classification

Cobalt chloride is already legally classified as skin sensitiser according to annex VI of regulation (EC) 1272/2008. This has been confirmed in animal tests and human case reports. Since, read-across to cobalt(2 +) disulfamate is considered to be fully justified cobalt(2 +) disulfamate will be classified as skin sensitiser category 1A (H317). Thus, further testing is not required, according to section 1.1.3 and 1.2, annex XI of regulation (EC) 1907/2006.

Since cobalt(2 +) disulfamate is produced and marked as 50% solution and the vapour pressure of this solution and cobalt(2 +) disulfamate tetrahydrate (only stable as tetrahydrate; see IUCLID section 4.6 "vapour pressure") is negligible and therefore, inhalation of cobalt(2 +) sulfamate is considered to be of low relevance, it is foreseen to not classify cobalt(2 +) disulfamate as respiratory sensitiser.