Registration Dossier

Administrative data

Description of key information

The substance has an oral LD50 of 720 mg/kg bw. In an acute dermal toxicity test the limit dose of 2000 mg/kg bw did not lead to mortality, the dermal LD50 is set to 2000 mg/kg bw by default.
A valid inhalative LC50 is not available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
500 mg/kg bw
Quality of whole database:
study is well described

Acute toxicity: via inhalation route

Endpoint conclusion
Quality of whole database:
The study shows drawbacks in its experimental design,
assessed by a companys expert: it is unclear if the adverse effects
are caused by the experimental design (increased temperature) or the substance itself

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The assessment by the regulatory organization mentions two studies,
both with insufficient documentation available.
A read-across from a study with the tolyltriazole sodium salt supports this conclusion

Additional information

Justification for selection of acute toxicity – oral endpoint
well performed study according to OECD and national guideline

Justification for selection of acute toxicity – inhalation endpoint
only one study available, which does not allow an endpoint conclusion

Justification for selection of acute toxicity – dermal endpoint
assessment by a regulatory organization

Justification for classification or non-classification

 oral  300 < LD50 < 2000 mg/kg bw  Acute Tox. 4; H302
 dermal  LD50 > 2000 mg/kg bw  not classified
 inhalative  waiving, because exposure unlikely  not classified