Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
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:
Publication with limited details on methods, but study seems to be performed under standardized conditions.

Data source

Reference
Reference Type:
publication
Title:
Food flavourings and compounds of related structure; I. Acute oral toxicity
Author:
Jenner PM, Hagan EC, Taylor JM, Cook EL and Fitzhugh OG
Year:
1964
Bibliographic source:
Food Cosmet. Toxicol. Vol. 2, pp. 327-343. Pergamon Press 1964.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
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:
A commercially available material was used.

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Young adults
- Weight at study initiation: No data
- Fasting period before study: 18 hours
- Water: Animals had access to water at all times

ENVIRONMENTAL CONDITIONS
No data


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
No data
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week.
- Frequency of observations and weighing: Frequency not known, all animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal or showed weight gain.
Statistics:
LD50's were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:
Not relevant
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 790 mg/kg bw
95% CL:
2 440 - 3 180
Remarks on result:
other: Slope function 1.3 (95% CI 1.2-1.4)
Mortality:
Death time 4-18 hr
Clinical signs:
other: Ataxia soon after treatment
Gross pathology:
No data
Other findings:
Not relevant

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of Linalool for rats was found to be 2790 mg/kg bodyweight. Based on this LD50 value, the substance is not classified according to Regulation (EC) 1272/2008.
Executive summary:

The acute oral toxicity of Linalool to rats was investigated. 10 animals per concentration were used, the substance was administered orally via gavage. The LD50 was found to be 2790 mg/kg body weight.