Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (male and female rats) > 5000 mg/kg bw (K, Rel.2).

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
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
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:
no
Principles of method if other than guideline:
standard acute method (limit test)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Diet: Food, ad libitum
- Water: Water, ad libitum
- Fasting period before study: Animals were fasted for 24 h prior to administration of the test item.
- Acclimation period: 1 week
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- Test material was administered as a concentrate
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None
Preliminary study:
Not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: One female animal died on Day 2
Mortality:
- One female animal died on Day 2.
- No mortality was observed in males.
Clinical signs:
- Prostration, coma, and death following dose administration were observed in non-survivor.
- All survivors showed morbidity (lethargic) and full recovery at 48 h.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, oral LD50 of JUNIPER BERRY OIL is higher than 5000 mg/kg bw in rats therefore it is not classified according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test), groups of Sherman-Wistar rats (5/sex/dose) were given a single oral dose of JUNIPER BERRY OIL at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.

Prostration, coma, and death following dose administration was observed in 1/5 female animal on Day 2. No mortality was observed in males. All survivors showed morbidity (lethargic) and full recovery at 48 h.

In this study, the oral LD50 of JUNIPER BERRY OIL was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, oral LD50 of JUNIPER BERRY OIL is higher than 5000 mg/kg bw in rats therefore it is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Only basic data given in the available study. However, only one death out of ten animals was observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.

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:

A key study was identified (Shelanski, 1972, Rel. 2). In this limit acute oral toxicity study, 10 rats (5/sex) were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.

One female died on day 2. No mortality was observed in males. Prostration, coma and death following dose administration were observed in non-survivor. All survivors showed morbidity (lethargic) and full recovery at 48 h.

Oral LD50 of Juniper oil was higher than 5000 mg/kg bw in rats.

Justification for classification or non-classification

Harmonized classification:

Juniper 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, Juniper oil is:

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

- not classified according to the GHS as the LD50 is greater than 5000 mg/kg bw.

Acute toxicity via Dermal route:

This information is not available and is not required for this tonnage band.

Acute toxicity via Inhalation:

This information is not available and is not required for this tonnage band.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the CLP and to the GHS 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.

The criteria for Transient Organ effects (STOT-SE Category 3) according to the CLP and to the GHS are not met since narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

Specific target organ toxicity: single exposure (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

 

Aspiration hazard:

According to the Regulation (EC) No. 1272/2008, Substances in Category 1 for aspiration hasard include but are not limited to certain hydrocarbons, turpentine and pine oil. Based on its composition (> 10% of aspiration toxicants, i.e. pinene alpha, myrcene beta), Juniper oil should be classified for aspiration hazard:

- H304, May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008 and to the GHS.

Source: ECHA disseminated dossiers

-Pinene alpha:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

- Myrcene beta:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d82fafa-8716-3e64-e044-00144f67d249/DISS-9d82fafa-8716-3e64-e044-00144f67d249_DISS-9d82fafa-8716-3e64-e044-00144f67d249.html

Categories Display