Juniper, Juniperus oxycedrus, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Some details of the experimental conditions are missing (test substance, animal conditions, bodyweights) but the main useful data are described.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Some details of the experimental conditions are missing (test substance, animal conditions, bodyweights) but the main useful data are described.

Principles of method if other than guideline:

Rats were treated with test item, Juniper tar by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).

GLP compliance:

no

Remarks:

pre-GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Juniper, Juniperus oxycedrus, ext.

EC Number:

289-969-0

EC Name:

Juniper, Juniperus oxycedrus, ext.

Cas Number:

90046-02-9

IUPAC Name:

Empyreumatic oil obtained from Juniperus oxycedrus (Cupressaceae) wood by dry distillation

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Juniper tar

Specific details on test material used for the study:

No data

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 18 h prior to treatment
- Diet: Food, ad libitum
- Water, ad libitum

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:

10 animals evenly divided by sex for the whole experiment

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 weeks

Statistics:

LD50 with 95 % confidence limits was calculated with use of Litchfield-Wilcoxon's method (1949).

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

8 014 mg/kg bw

Based on:

test mat.

95% CL:

>= 6 550 - <= 9 770

Mortality:

Mortality was observed between 4 h and 4 days after test item administration.

Clinical signs:

other: Depression soon after treatment, scrawny appearance for several days and irritated gastrointestinal tract.

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for Juniper tar is higher than 2000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an acute oral toxicity study, young adult Osborne-Mendel rats were treated with undiluted Juniper tar by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).

Mortality was observed between 4 h and 4 days after test item administration with depression soon after treatment, scrawny appearance for several days and irritated gastrointestinal tract. In this study, the oral LD50 of test item was 8014 mg/kg bw (95 % Cl: 6550-9770) in rats.

 

Under the test conditions, the oral LD50 for Juniper tar is higher than 2000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).