Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 > 5000 mg/kg bw, OECD Guideline 401, GLP compliant
Acute inhalation toxicity: LC50 > 2.42 mg/L, according to OECD Guideline 403, GLP compliant
Acute dermal toxicity: no data available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The key studies are GLP-compliant and of high quality (Klimisch 1).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
2 420 mg/m³
Quality of whole database:
The key study is GLP-compliant and of high quality (Klimisch 1).

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data are available for the dermal route, hower dermal is not considered to be the major route of exposure for tellurium. Furthermore, the physicochemical and toxicological properties do not suggest potential for significant rate of absorption through the skin.

No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.


Justification for selection of acute toxicity – oral endpoint
Data from three studies conducted according to OECD guideline 401 are available, two with rats and one with mice.
In all studies the LD50 was > 5000 mg/kg bw.

Justification for selection of acute toxicity – inhalation endpoint
In the acute inhalation toxicity study, according to OECD guideline 403 (Acute inhalation toxicity) the LC50 was > 2.42 g/m³ air.

Justification for classification or non-classification

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) no classification and labelling would be required for tellurium for acute oral, based on acute oral toxicity value of LD50 > 5000 mg/kg bw.

For the inhalation route classification in the acute toxicity category IV is required based on the LC50 value of > 2.42 mg/L air.