Registration Dossier

Administrative data

Description of key information

The acute oral and dermal LD50 values of sulfur are higher than 2000 mg/kg bw. The acute inhalation LC50 is higher than 5.43 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 430 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

In a GLP compliant OECD guideline acute oral toxicity study, groups of 5 male and 5 female Wistar rats received a single oral dose of 2000 mg/kg

bw of sulfur by gavage. The animals were observed for 14 days after administration after which survivors were sacrificed and necropsied. No animals

died as a result of treatment. Clinical signs such as laboured respiration, rales (in 1 male only), nose staining, and piloerection were seen in both

male and female rats, but the animals recovered within 5 days. The oral LD50 value for sulfur is higher than 2000 mg/kg bw based on this study.

In a GLP compliant OECD guideline acute dermal toxicity study, groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000

mg/kg bw of sulfur (powder), administered as a suspension in corn oil. Clinical signs and bodyweight gain were monitored for 14 days after

application, after which the animals were sacrificed and necropsied. No animals died as a result of treatment. Clinical signs (nose staining,

minimal erythema and scaling at the application site) were seen in both male and female rats, and animals affected recovered within 6 days.

The dermal LD50 value for sulfur is higher than 2000 mg/kg bw based on this study.

The 4 hour LC50 of sulfur was determined in a GLP study in accordance with EPA guideline OPP 81-3. A group of five male and five female rats was exposed to a concentration of 5.43 g/m3 during a single period of four hours. The animals were observed for 14 days after exposure after which survivors were sacrificed and necropsied. Two animals died within the first day of exposure. The mortality was most probably due to the very high, acute, dust load and not the toxicity of the test material. The surviving animals recovered and within one week of exposure no clinical signs and changes in body weight gain were observed anymore. Since 8 of 10 treated animals survived, it was concluded that the 4 hour LC50 value was higher than 5.43 g/m3.

Justification for selection of acute toxicity – oral endpoint

Only available study.

Justification for selection of acute toxicity – inhalation endpoint

Only available study.

Justification for selection of acute toxicity – dermal endpoint

Only available study.

Justification for classification or non-classification

In accordance with the EU CLP Regulation (EC No. 1272/2008), classification is not necessary for acute oral, inhalation and dermal toxicity based on the available data.