Registration Dossier

Administrative data

Description of key information

SIKA Hardener MH was tested for acute oral toxicity in study with rats according to OECD Guideline 423 (Acute toxic class method). The study revealed an acute oral toxicity greater than 2000 mg/kg bw  in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP and guideline study

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

Acute oral toxicity:

SIKA Hardener MH was tested for acute oral toxicity in study with rats according to OECD Guideline 423 (Acute toxic class method).

The acute toxic class method (OECD Guideline No. 423) was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

No lethality was noted at single oral dose of 2000 mg/kg bw. In first and second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal.

The body weight development was undisturbed in all animals.

All animals survived until the scheduled autopsy on Day 15. All organs of all experimental animals proved to be free of treatment related gross pathological changes.

Thus, an LD50 of greater than 2000 mg/kg bw was determined.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
Exposure via inhalation is not considered relevant, due to unlikely exposure via inhalation.

Justification for selection of acute toxicity – dermal endpoint
Exposure via dermal route is not considered relevant, due to unlikely exposure dermal route.

Justification for classification or non-classification

Based on results obtained in acute toxicity studies SIKA Hardener MH was not classified and labelled according to Directive 67/548/EEC (DSD)

and Regulation (EC) No 1272/2008 (CLP).