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Administrative data

Description of key information

Acute toxicity:
- oral: LD50 = 6330 mg/kg bw (Jenner 1964)
- dermal: LD50 > 6 ml/kg bw (Levenstein, 1972) - Neryl acetate

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

In the chosen key study, i.e. an acute oral toxicity, five Osborne-Mendel rats per sex and dose were dosed with geranyl acetate via gavage (Jenner, 1964) and observed for 14 days. Mortality was observed between 4 hours and 72 h after dosing, and a LD50 of 6330 mg/kg bw was estimated.

In an supportive study, food-grade geranyl acetate containing 71% geranyl acetate (CAS 105-87-3) and 29% citronellyl acetate (CAS 150-84-5) was used, which was conducted in accordance with NTP specific guidelines to find and delimit the concentration range to be tested within a following 14 day toxicity study (NTP, 1987). Five Fischer 344 rats per sex and dose were administered by gavage with doses of 500, 1000, 2000, 4000, 8000 mg/kg bw in corn oil. Mortality was only noted in the 8000 mg/kg bw group, where all of the animals died within two days. In the same study, five B6C3F1 mice per sex and dose were administered with doses of 500, 1000, 2000, 4000, 8000 mg/kg bw in corn oil . As a result, four of five males and all females of the 8000 mg/kg bw group died within three days. No mortality was observed in lower dose groups.

 

In the key study of the structurally related respective stereoisomer (nerylacetate; CAS 141 -12 -8) for acute oral toxicity, five male and five female rats were gavaged once with 5 ml/kg neryl acetate (Levenstein, 1972). No mortality was observed within the 14 day observation period, and the LD50 was set at >5 ml/kg bw (correspondig to approx >4550 mg/ kg bw).

Acute inhalative toxicity:

No data are available for acute inhalative toxicity of geranyl actetate. For the coverage of a second and human relevant route of exposure, data  on acute dermal toxicity are available for the structurally related stereoisomer (neryl acetate). Based on the available acute oral and dermal data, no acute inhalative toxicity for geranyl actetate is indicated.

Acute dermal toxicity:

No key study for acute dermal toxicity is available for geranyl acetate.

In the key study of the structurally related respective stereoisomer (nerylacetate; CAS 141 -12 -8) for acute dermal toxicity, four rats per group received applications of 2, 3.9 and 6 ml/kg bw neryl acetate under occlusive conditions for 24 h (Levenstein, 1972). Since no toxic effects as well as no mortality was observed within the 14 day observation period, the LD50 value was found to be >6 ml/kg bw corresponding to >5460 mg/kg bw.

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.