Registration Dossier

Administrative data

Description of key information

Oral rat LD50 > 2000 mg/kg bw

Inhalation: study scientifically unjustified

Dermal rat LD50 > 2000 mg/kg bw

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 study available

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 the assessment of both acute oral toxicity and acute dermal toxicity a limited test was performed on rats (males and females), with the application of a single dose of 2000 mg/kg bw. Both studies were conducted according to the OECD Guidelines (No. 401 and 402 for oral and dermal toxicity respectively. Since any relevant toxicity effect could not be observed, the test substance can be considered to be not acutely toxic, with a LD50 >2000 mg/kg bw by both dermal and oral routes.

 

The inhalation exposure route was not assessed because, according to column 2 (information requirement section 8.5), Annex VIII of REACH Regulation , the study does not need to be conducted since exposure by inhalation is very unlikely and acute toxicity studies are already available for both oral and dermal route.

Despite the MMD of the substance is 3.1 µm (i.e. respirable fraction), exposure by inhalation route is unlikely to happen because of the physical state of the substance when imported and adopted RMMs.

In fact, since the chemical is imported as a component of a liquid solution, dust inhalation will not be taken into account. Inhalation exposure can still occur if mists are produced, but this would only occur under certain conditions such as leaks from a pressurised system. Formation of vapours from the solution containing the chemical is also very unlikely, due to its negligible vapour pressure.

In addition, the substance is used in tanneries to dye hides and it was reported to be strongly chemically bound to the substrate one the hides are dried, limiting therefore the exposure to workers and general population.

Justification for classification or non-classification

The substance has a rat acute oral LD50 >2000 mg/kg bw. As a result, the substance does not meet the criteria for classification according to regulation EC 1272/2008 (CLP), Annex I section 3.

 

The substance has a rat acute dermal LD50 >2000 mg/kg bw. As a result, the substance does not meet the criteria for classification according to Regulation EC 1272/2008, Annex I section 3.

 

In addition, the inhalation route is very unlikely to be interested since the substance is a solid with negligible vapour pressure which decomposed before boiling.