Registration Dossier
Registration Dossier
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EC number: 290-370-1 | CAS number: 90131-58-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thuya occidentalis, Pinaceae.
Acute Toxicity: oral
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:
- 1 973
- 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
- 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
Constituent 1
- 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"
- Clinical signs:
- other:
- 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.
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