Registration Dossier

Administrative data

Description of key information

Acute toxicity:
- oral: LD50 > 5 ml/kg bw (Levenstein 1972) - Neryl acetate
- oral: LD50 = 6330 mg/kg bw (Jenner 1964) - Geranyl acetate
- dermal: LD50 > 6 ml/kg bw (Levenstein, 1972) - Neryl acetate

Key value for chemical safety assessment

Additional information

No acute toxicity data are available for the respective reaction mass.

Acute oral toxicity:

In the chosen key study 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).

In the chosen key study for acute oral toxicity from secondary source, 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.

Overall, based on the main constituents, the respective reaction mass is considered to be non toxic after single oral administation.

Acute inhalative toxicity:

No data are available for acute inhalative toxicity of the reaction mass or its main components. For the coverage of a second and human relevant route of exposure, data on acute dermal toxicity are available for one of its main components, being structurally related to the other main component (respective stereoisomer). Based on the available acute oral and dermal data on the main components, no acute inhalative toxicity for the respective reaction mass is indicated.

 

Acute dermal toxicity:

In the key study 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.

 

Overall, based on the data available for one of its main components, being structurally related to the other main component (respective stereoisomer) the reaction mass is considered to be non toxic after single dermal administation.

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.