Registration Dossier

Administrative data

Description of key information

Acute toxicity was determined in male and female Sprague-Dawley rats using oral gavage and semiocclusive dermal exposure according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) or OECD Guideline 402 (Acute Dermal Toxicity). The study using dermal exposure was performed sing an analogue substance.
LD50 values were greater than 2000 mg/kg bw in both studies.
Inhalation: The test material is produced and handled in industry exclusively in aqueous solutions. There are no spraying operations. Thus neither exposure via inhalation nor risks are expected via the inhalation route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The substance did not cause any relevant adverse effects after single oral exposure in rats.

24h of semi-occlusive dermal exposure to an analogue substance did produce slight, transient adverse effects in female rats only. The substance is also not expected to produce severe effects after acute dermal exposure.

The test material is produced and handled in industry exclusively in aqueous solutions. There are no spraying operations. Thus neither exposure nor risks are expected via the inhalation route.

Justification for classification or non-classification

No mortality was observed in any of the studies after application of the maximum recommended doses (limit tests). Therefore, the material was not classified.