Registration Dossier

Administrative data

Description of key information

The oral LD50 for Na2Sx is 85.8 (95% CI 73.8 - 99.6) mg/kg bw.

The dermal LD50 Na2Sx is 590 mg/kg bw.

An inhalation study was not performed and an LD50 is not available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
85.8 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
590 mg/kg bw

Additional information

For acute toxicity endpoints data from disodium tetrasulfide and disodium disulfide is used, for further justification see attached document.

The oral LD50 for disodium tetrasulfide is 130 mg/kg bw (95% CI 81 -180) for males and 128 mg/kg bw (95% CI 66 -324) for females.

The oral LD50 for disodium disulfide is 82.5 (95% CI 60.8 - 112) mg/kg bw for males and 92.8 (95% CI 68.8 - 127) mg/kg bw for females. Combined the LD50 is 85.8 (95% CI 73.8 - 99.6) mg/kg bw.

The dermal LD50 for disodium tetrasulfide in female animals was estimated at 590 mg/kg bw. The LD50 for males was estimated at 1650 mg/kg bw.

For disodium disulfide determination of a dermal LD50 value was impossible, because of the limited number of animals used in the study (2 animals). One animal was found dead at the end of the day of dosing and the second animal was killed after 24 hours because of the corrosion to the skin that was observed. Further testing is unjustified due to the corrosive properties of the test substance.

An inhalation study was not performed and an LD50 is not available.

Justification for classification or non-classification

Sodium sulfide (Na2(Sx)) has been classified as Acute Tox. 3 based on the available information for oral acute toxicity and Acute Tox. 3 based on the available information for dermal acute toxicity. There is no data available for acute inhalation toxicity therefore the substance is not classified.