Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study can be compared to the OECD 401 guideline for testing acute oral toxicity. It seems that the study was not performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Thuya occidentalis, ext.
EC Number:
290-370-1
EC Name:
Thuya occidentalis, ext.
Cas Number:
90131-58-1
Molecular formula:
not relevant for a UVCB substance
IUPAC Name:
Essential oil of thuya occidentalis obtained from leaves by steam distillation
Test material form:
liquid
Specific details on test material used for the study:
sample marking 72-93 Cedarleaf oil

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
410, 660, 1040, 1630 and 5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality were made daily
- Observed Symptomatology

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 0.69 - < 0.97 mg/kg bw
Based on:
not specified
Mortality:
see the table on section"any other information on materials and methods incl. tables"
Other findings:
at 5g/kg : convulsions
lower doses : none

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the experimental conditions of this study, the mean oral LD50 calculated from the data is 830 mg/kg, the test substance is classified category 4 (H302) according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.