Registration Dossier

Administrative data

Description of key information

LD50 > 8000 mg/kg

LD0 = 8000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Based on literature data (Gaunt 1967), the substance is non toxic upon acute administration by oral route to rats and mice. In particular, no deaths were seen up to the highest tested dose.

Therefore, LD0 is 8000 mg/kg and LD50 > 8000 mg/kg.

Systemic effects were reported as slight colouration of animals, faeces and urine as well as lethargy for a few hours upon administration.

In the same study (Gaunt 1967), acute intraperitoneal toxicity was also assessed showing: LD50 = 600 mg/kg in male rats and 2600 mg/kg in female rats; LD50 = 1900 mg/kg in male mice and LD50 = 1600 mg/kg in female mice. Rapid uptake and distribution of the substance was seen. At necropsy, kidneys were pale and speckeld; tubular necrosis was seen, starting to recover within the 7 days observation period.

A study on acute inhalation toxicity was not conducted, based on particle size of the substance, i.e. a powder form with small fraction of inhalable particles, and negligible vapour pressure.

A study on acute dermal toxicity was not conducted, due to the low potential for dermal absorption along with the low acute toxicity observed by oral route. Absorption is expected to be higher orally than dermally.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

No classification for acute dermal and inhalation toxicity was applied, based on considerations on physicochemical properties and absorption rate.

In conclusion, the substance does not meet the criteria to be classified for oral and dermal acute toxicity, according to the CLP Regulation (EC 1272/2008).