Registration Dossier

Administrative data

Description of key information

Acute toxicity:
- oral: LD50 > 6400 mg/kg bw (BASF 1972, XXI/221)
- dermal: > 2000 mg/kg bw (Moreno 1973)

Key value for chemical safety assessment

Additional information

Acute oral toxicity

In the chosen key study for acute oral toxicity in part equivalent to OECD guideline 401, ten Sprague-Dawley rats per sex and dose were treated via gavage by doses of 200, 1600, 3200, 6400 mg/kg bw hydroxycitronellal in carboxymethyl cellulose (BASF 1972, XXI/221). One single male animal in the 3200 mg/kg dose group died, and a LD50 value of >6400 mg/kg bw was set.

In a supportive study, the LD50 was found to be >5000 mg/kg/bw when 10 rats received application of 5000 mg/kg bw (Moreno, 1973).

Acute inhalative toxicity

No valid key study is available for hydroxycitronellal. However, for the coverage of a second and human relevant route of exposure, a study on acute dermal toxicity is available. No evident acute toxicity after single oral or dermal exposure has been observed for hydroxycitronellal. In support, in an inhalation hazard test in rats (exposure to a vapour saturated atmosphere at 20°C and 40°C for 8 hours) no mortality was observed, providing further evidence for the absence of an acute inhalative toxicity potential (BASF 1972, XX/221a). Overall, no further testing in animals is considered mandatory.

Acute dermal toxicity

In the chosen key study for acute dermal toxicity in two rabbits, a LD50 of >2000 mg/kg bw has been reported (Moreno, 1973).

Justification for classification or non-classification

The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.