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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study not conducted according to international guideline, but performed under standardized conditions. No data on whether study was conducted under GLP.

Data source

Reference
Reference Type:
publication
Title:
Fragrance Compounds and Essential Oils with Sedative Effects upon Inhalation
Author:
Buchbauer G, Jirovetz L, Jäger W, Plank C and Dietrich H
Year:
1993
Bibliographic source:
Journal of Pharmaceutical Sciences, Vol. 82, No. 6, pp 660-664, June 1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice were exposed to linalool in air under standardized conditions, and the effect on motility was determined. In addition blood samples were drawn 0m 30, 60 & 90 minutes after inhalation and plasma was analysed by GC-MS, GC-FTIR & GC-FID for the presence of linalool.
GLP compliance:
no
Test type:
other: Inhalation study under standardized conditions
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Linalool
EC Number:
201-134-4
EC Name:
Linalool
Cas Number:
78-70-6
Molecular formula:
C10H18O
IUPAC Name:
3,7-dimethylocta-1,6-dien-3-ol
Details on test material:
- Name of test material (as cited in study report): Linalool
- Substance type: fragrance compound

Test animals

Species:
mouse
Strain:
Swiss
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 6-8 week and 6 months old
- Weight at study initiation: 28.5 g
- Housing: In groups of 4 on a bedding of wood shavings in polycarbonate cages (Makrolon, type II)
- Diet: Standardized pelleted food T 799 (Tagger, Graz, Austria) ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 60 ± 10%
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
other: experimental procedure according to Kovar et al. (1987) and technical characteristics according to Buchbauer et al. (1992)
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
No data
Analytical verification of test atmosphere concentrations:
yes
Remarks:
To calculate the air concentration of the fragrance compounds in the cage to determine the total drug volume (20-50 mg per compound), the charcoal tubes (120, NIOSH, Catalogue no. 226-01) supplied by Drager Company, Lübeck, Germany were used.
Duration of exposure:
1 h
Concentrations:
No data
No. of animals per sex per dose:
No data
Control animals:
yes
Details on study design:
- Duration of observation period following administration: minimum 10 minutes
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: the motility of the mice was examined.
Statistics:
Statistics were calculated with an Atari 1040 personal computer (WISTAT scientific statistic package program). Significance was determined by the t test and F-test; the level of significance chosen for p to reject the null hypothesis was <0.05.

Results and discussion

Preliminary study:
Not relevant
Effect levels
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
> 20 other: mg
Exp. duration:
1 h
Remarks on result:
other: no deaths after exposure to 20-50 mg linalool
Mortality:
No data
Clinical signs:
other: The exposure led to a decrease in motility of the mice. After a 1-h inhalation period, the motility of mice exposed to linalool was 73% lower than the motility of the untreated control animals.
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Any other information on results incl. tables

The concentration of linalool in the blood samples following inhalation was 4.22 ng/mL.

Applicant's summary and conclusion

Interpretation of results:
other: causes a decrease in motility in mice
Remarks:
Criteria used for interpretation of results: other: no criteria used
Conclusions:
Linalool caused a decrease in motility in mice of 73% when exposed to 20-50 mg compound in a 1-hour inhalation study.
Executive summary:

The influence of linalool on the motility in mice was tested in an inhalation study under standardized conditions. After a 1 -hour inhalation period, the motility in the exposed mice was decreased by 73% compared to the motility of untreated control animals. No deaths were reported at the concentration tested (20 -50 mg).