Registration Dossier
Registration Dossier
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EC number: 233-732-6 | CAS number: 10339-55-6
Endpoint summary
Administrative data
Description of key information
28-day oral toxicity study in rat (linalool), NOAEL: 117 mg/kg bw/day
90-day dermal toxicity study in rat (linalool), NOAEL: 250 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 117 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
No experimental data for ethyllinalool are available. However based on the read-across approach to linalool and dehydrolinalool, it is expected that ethyllinalool may produce (i) sedation upon oral and dermal exposure, (ii) hypersalivation upon oral ingestion, (iii) (fore)stomach inflammation and acanthosis, (iv) increased liver and kidney weights, (v) periportal cytoplasmatic vacuolation in liver most likely due to enzyme induction, (vi) alpha-2u-globulin nephropathy in male rats. Repeated dermal application may result in epithelial hyperplasia due to irritating properties of the test item.
Details
The 28-day oral toxicity study with Coriander oil containing 72.9% linalool established a NOAEL of 117 mg linalool/kg bw/day based on observed effects in the stomach in both sexes (thickened mucosa, inflammation and acanthosis) and kidney in males (regeneration and necrosis of tubules, alpha-2u-globulin nephropathy). Although hepatocellular cytoplasmic vacuolisation and increased liver weight were observed in treated females, these effects are probably the result of metabolizing enzyme induction and can therefore be considered rather an adaptive change than an adverse effect. The LOEL was 292 mg linalool/kg bw/d.
A 28-day repeated dose toxicity study on dehydrolinalool was also available, which established a NOAEL of 200 mg/kg bw/day based on an increased relative liver weight and hydrocarbon nephropathy in males.
Alpha-2u-globulin nephropathy is not considered relevant for human health.
The most relevant NOAEL of 117 mg/kg bw/day from the key study was selected.
The 90-day dermal toxicity study established a NOAEL of 250 mg linalool/kg bw/day based on lower body weights compared to controls and skin irritation. The LOEL was 1000 mg/kg bw/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach; urogenital: kidneys
Repeated dose toxicity: dermal - systemic effects (target organ) other: skin
Justification for classification or non-classification
Based on the criteria outlined in 67/548/EEC and 1272/2008/EC and the read-across approach to structural related substances, ethyllinalool does not have to be classified with regard to repeated toxicity.
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