Reaction mass of 2,6-Octadien-1-ol, 3,7-dimethyl-, (E) and 2,6-Octadien-1-ol, 3,7-dimethyl-, (Z)-

Endpoint summary

Description of key information

- Acute toxicity:
Oral: LD50: 3600 mg/kg for rat (geraniol)
Oral: LD50: 4500 mg/kg for rat (nerol)
Dermal: LD50: >5000 mg/kg for rabbit (geraniol and nerol)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 600 mg/kg bw

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

Value:

5 000 mg/kg bw

Additional information

Oral

Geraniol

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).

Nerol

To evaluate the acute oral toxicity of nerol, ten male Wistar rats per dose were orally administered with doses of 2560, 4000, 6250 and 9800 mg/kg bw (Moreno, 1972). Since mortality was noted within the 14 day observation period, a LD50 of 4500 mg/kg bw was calculated.

Inhalation

Geraniol

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).

Nerol

To analyze the acute inhalative toxicity of nerol, five CF-1 mice were cannulated via the trachea and exposed for 1 min with an aerosol (Troy, 1977). As a result an effective dose (ED) of 0.59 mg/l for nerol was found. However, due to limited exposure time, this study could not be taken for assessment.

Dermal

Geraniol

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.

Nerol

Acute dermal toxicity was evaluated in a study, where pure nerol was applied under occlusion to the clipped abraded abdominal skin of ten New Zealand White rabbits (Moreno, 1972). Although one death occurred within the seven days observation period, a LD50 >5000 mg/kg bw was estimated.

Justification for classification or non-classification

Due to oral LD50 value of 3600 mg/kg for Geraniol and 4500 mg/kg for Nerol and a dermal LD50 >5000 mg/kg bw for both Geraniol and Nerol, the reaction mass was considered to have LD50 values in the same ranges and hence does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008.