Thuya occidentalis, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data are given, but considered sufficiently reliable for the purpose of hazard assessment.

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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Standard acute method : 10 rabbits were administered dermal doses of the test substance at 2500 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

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:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Duration of exposure:

14 days

Doses:

2500 and 5000 mg/kg

No. of animals per sex per dose:

4 animals at 2500 mg/kg
10 animals at 5000 mg/kg

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: Mortality, clinical signs and dermal reactions.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 800 - < 6 800 mg/kg bw

Based on:

test mat.

Mortality:

see table above :
at 2500 mg/kg : 1 death /4 animals
at 5000 mg/kg : 6 deaths / 10 animals

Clinical signs:

other: at 2500 mg/kg and 5000 mg/kg : convulsions and salivations

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the experimental conditions of this study, the mean oral LD50 calculated from the data is 4100 mg/kg, the test substance is classified category 5 (H316) according to GHS.