Registration Dossier

Administrative data

Description of key information

- Acute toxicity:
Oral: LD50: 3600 mg/kg for rat
Dermal: LD50: >5000 mg/kg for rabbit

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 600 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

The acute oral toxicity of geraniol was analyzed in a study with five Osborne-Mendel rats per sex and dose (Jenner, 1964). After Fasting for 18 h, the animals were administered by gavage and observed for 14 days. Since mortality was observed between 4 hours and 18 h after dosing, a LD50 of 3600 mg/kg bw was estimated. Although the used material showed additional isomer composition, this study was regarded as reliable since it was cited by several publications, including in the WHO Food Series published by the WHO.

In another study, geraniol in propylene glycol was administered up to eight rats of mixed strains per dose group at concentrations of 1, 5, 10, 100, 1000, 2000, 5000 mg/kg bw (Yamawaki, 1962). Since three of five rats of the high dose group died within the 48 h observation period, the LD50 was calculated to be 4800 mg/kg bw.

In a short report, which could not be taken into account for assessment, LD50 values of 2100-4500 mg/kg and 3500 mg/kg bw were reported as for rats and mice, respectively (Volkova, 1998).

The acute inhalative toxicity was analyzed in a study with rabbits which were exposed to a vapor of 1, 1.5, 3, 9, 27, 81 mg/ml geraniol in ethanol for four hours (Boyd, 1970). Since no mortality was observed, a LC0 of 81 mg/ml was determined.

In another study, five CF-1 mice were cannulated via the trachea and exposed for 1 min resulting in an ED25 value of 0.57 mg/l air (Troy, 1977).

Also a lowest toxic concentration (TCLo) of 0.5 mg/m3 air for rats was reported in a short report (Volkova, 1998).

To determine the acute dermal toxicity 5000 mg/kg bw was applied to skin of three rabbits (Moreno, 1972). Since no mortality was noted during the 14 d observation time, the dermal LD50 was estimated as > 5000 mg/kg.

The following studies also evaluated the acute toxicity of geraniol, but due to their method used and deficits in reported data, they could not be taken for assessment.

In a study with rabbits a LD50 of 50 mg/kg bw was found after intravenous injection of geraniol (Yamawaki, 1962).

Intramuscular injection of 4000, 6000, 8000, 10000 and 12000 mg/kg geraniol to 10 mice per dose let to a LD50 of 4000 mg/kg bw (Northover, 1962).

In another study, five mice per sex and dose were injected subcutaneously with 0.3 ml geraniol in olive oil (Nozawa, 1952). As a result, a LD50 of 1090 mg/kg bw was calculated.

When five mice per dose group were injected intraperitoneally with an emulsion of geraniol (1:10) at doses of 440, 880, 1760 mg/kg bw, a LD100 of 1760 was found (Lysenko, 1962).

Justification for classification or non-classification

Due to oral LD50 value of 3600 mg/kg and a dermal LD50 >5000 mg/kg bw, Geraniol does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008.