Registration Dossier

Administrative data

Description of key information

The LD50 for oral toxicity is 500 mg/kg bw.
The LD50 for dermal toxicity is above 2000 mg/kg bw.
No information on inhalative toxicity 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:
Two studies available, one GLP OECD-Guideline and one Non-GLP study. The results of the studies are in the same LD50 interval.

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
2 000 mg/kg bw
Quality of whole database:
Only one study of an analogue substance available.

Additional information

Justification for selection of acute toxicity – oral endpoint
The acute median lethal oral dose (LD50) to rats of the substance is demonstrated to be between 200 and 2000 mg/kg bodyweight.
By default, this is equivalent to LD50 = 500 mg / kg bw.

Justification for selection of acute toxicity – dermal endpoint
A read across to the analogue substance 2,2'-azobis(2-methylpropionamidine) sulfate is possible.
No other information available.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 the substance is classified as Hazard category 4 for acute oral toxicity. For this classification the substance has to be labelled with the signal word “Caution”.

The presented data for acute dermal toxicity is reliable and an adequate guideline study. The observations within the study are conclusive but not sufficient for a classification according to Regulation (EC) No. 1272/2008.

No classification for the inhalation route is considered appropriated because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.