Juniper, Juniperus oxycedrus, ext.

Endpoint summary

Description of key information

Acute toxicity, oral, similar to OECD guideline 401, rats: LD50 = 8014 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

Specific details on test material used for the study:

No data

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

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).

Preliminary study:

None

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

None

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

8 014 mg/kg bw

Quality of whole database:

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

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: via oral route

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.

Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for classification or non-classification

Harmonized classification:

Cade oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, Cade oil is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw

Acute toxicity via Dermal route:This information is not available

Acute toxicity via Inhalation:This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal): This information is not available

Specific target organ toxicity: single exposure (Inhalation): This information is not available.

Based on its composition (< 10% of aspiration toxicants or hydrocarbons), Cade oil is not classified for aspiration hazard.