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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
experimental study
Test substance represents a main component (stereoisomer) of the registered substance.
Adequacy of study:
other information
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No quantification of the test substance concentration due to low volatility at room temperature; limited experimental setup allowing no derivation of a LC50.

Data source

Reference Type:
study report
Report date:

Materials and methods

Principles of method if other than guideline:
An inhalation hazard test was conducted. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (usually 20°C). Several groups of usually 3 rats per sex were sequentially exposed to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted disc in a glass cylinder for different time periods.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually was calculated as quotient of the amount of the test substance weight loss during exposure. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.
GLP compliance:
Test type:
other: inhalation hazard test

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): trans-Nerolidol
- Physical state: colourless liquid
- Analytical purity: 99 %
- Storage condition of test material: at room temperature
Specific details on test material used for the study:
Test substance represents a main component (stereoisomer) of the registered substance.

Test animals

other: SPF-Wistar/Chbb:THOM
Details on test animals or test system and environmental conditions:
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: ca. 8-9 weeks
- Weight at study initiation: males 295 g, females 217 g
- Housing: 3 animals per cage (wire-mesh cages type D III, Becker & Co.) without litter
- Diet: Kliba laboratory diet rat/mouse 24-343-4, 10 mm pellet (Klingentalmuehle AG, Kaiseraugst, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

- Temperature: 20-24 °C
- Humidity: 30-70 %
- The animals were housed in fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
other: The animals were exposed to atmosphere saturated with the volatile parts of the test material in the air at 20 °C.
Details on inhalation exposure:
Saturation of the atmosphere was generated by conducting an air stream through a substance layer of 5 cm height
The rats were exposed to the test atmosphere for 7 hours
Air flow was 200 l/h in the exposure chamber
Analytical verification of test atmosphere concentrations:
Duration of exposure:
7 h
Vapour saturated air at 20°C (nominal concentration not quantifiable due to low volatility)
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of post exposure period until necropsy: 14 days
- Frequency of weighing: Test animals were weighed at test initiation only
- Frequency of observations: The animals were observed daily for mortality and clinical signs of toxicity on working days
- Necropsy of survivors performed: The necropsy of the animals was done on day 14 following exposure

Results and discussion

All animals exposed to the test material survived.
Clinical signs:
other: Snout wiping was observed during exposure. After exposure no clinical signs were observed.
Body weight:
Only initial body weights were recorded.
Gross pathology:
Autopsy revealed no findings.
Other findings:
Due to the low volatility of the substance at 20 °C, the mean concentration of the test material during 7 h exposure was not determinable by weighing.

Applicant's summary and conclusion