Registration Dossier

Administrative data

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:

The LD50 of the substance in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight (OECD 423).

Soluble cobalt substances:

The references Speijers (1982) and Llobet, Domingo (1983) are considered as the key studies for acute oral toxicity and will be used for classification. Female/male rats were dosed at 500, 600, 720, 864, 1137 mg/kg bw orally via gavage and at 350, 392, 450, 518, 595, 684, 787mg/kg orally via gavage respectively. During the conduct of the study mortalities occurred, thus the following LD50 values were derived:

  • Speijers (1982): LD50 (combined male and female rats): 766 mg/kg bw (95 % confidence interval: 677 - 867 mg/kg bw)
  •  Llobet, Domingo (1983): LD50: 537 mg/kg (Confidence interval: 479 – 601 mg/kg bw)

Using the lowest LD50 value for cobalt dichloride hexahydrate (537 mg/kg bw) and the value for sodium sulfamate (2500 mg/kg bw), considering a cobalt content of 23.47% and a sulfamate content of 76.53% in cobalt(2 +) disulfamate, the calculated LD50 value for cobalt(2 +) disulfamate using the ATE formula given in ECHA guidance document R.7a resulted in an LD50 of 387.4 mg cobalt(2 +) disulfamate/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
387.4 mg/kg bw
Quality of whole database:
Reliable studies performed with cobalt dichloride hexahydrate and sodium sulfamate are available. Since read-across is performed and considered fully justified no studies should be initiated with cobalt(2+) disulfamate.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Acute toxicity, oral:

The classification criteria according to regulation (EC) 1272/2008 as acutely toxic category 4 are met since the ATE is above 300 mg/kg body-weight and below 2,000 mg/kg body-weight. Cobalt(2 +) disulfamate will be classified as acutely toxic category 4 (H302).

Specific target organ toxicant (STOT) – single exposure: oral

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since the toxic effects observed in the acute oral toxicity test already leads to an acute oral toxicity classification. No additional effects in animals or humans are known that would justify a specific target organ toxicant (STOT) – single exposure: oral classification.