Registration Dossier

Administrative data

Description of key information

There are no animal studies available which examine the sensitizing properties of hydrazine.
In a maximization test with human volunteers hydrazine showed sensitizing properties (Kligman 1966).

Despite numerous descriptions of irritative reactions of the respiratory passages to hydrazine in the literature, there is no evidence that hydrazine causes allergic reactions in the respiratory tract. Specific animal experiments are not available (SCOEL 2016).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There are no animal studies available which examine the sensitizing properties of hydrazine.

In a maximization test with human volunteers hydrazine showed sensitizing properties (Kligman 1966). Hydrazin and its derivatives are skin sensitizing in man and may cause contact dermatitis, cross reactivity is also reported (Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin [Kayser und Schlede, eds.], 2001).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Despite numerous descriptions of irritative reactions of the respiratory passages to hydrazine in the literature, there is no evidence that hydrazine causes allergic reactions in the respiratory tract (SCOEL 2016).

Justification for classification or non-classification

Skin sensitization

Under Regulation No. 1272/2008 (GHS), the substance is classified in Skin Sensitization Class 1, Hazard Statement H317: May cause an allergic skin reaction. Based on the study of Kligman (1966) a classification as Skin Sens. 1A is proposed.

Respiratory sensitization

According to the available information no classification/labelling is warranted.