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Administrative data

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.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1972
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to a non-standard method and documentation was insufficient for assessment.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Principles of method if other than guideline:
Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
Duration of treatment / exposure:
Single treatment (24 h exposure)
Observation period:
14 days
Number of animals:
Total: 6 animals (3 intact skin and 3 abraded skin animals)
Irritation parameter:
other:
Basis:
other:
Remarks:
In an acute dermal toxicity study (limit test)
Time point:
14 d
Remarks on result:
other: Moderate erythema followed by drying, cracking, and shedding of the skin was observed.
Irritant / corrosive response data:
- Moderate erythema followed by drying, cracking, and shedding of the skin was observed.
Other effects:
- One animal with abraded skin was died on Day 6.

None

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, Juniper Berry Oil induced moderate skin irritation in rabbits.
Executive summary:

In an acute dermal toxicity study (limit test), six albino rabbits (three with intact skin and three with abraded skin) were given a single dermal application of Juniper Berry Oil at 5000 mg/kg bw. Animals were observed for mortality, clinical signs and local reactions daily for 14 days.

 

One animal with abraded skin was died on Day 6. No animal with intact skin died. Moderate erythema followed by drying, cracking, and shedding of the skin was observed. In this study, the acute dermal LD50 of Juniper Berry Oil was higher than 5000 mg/kg bw in albino rabbits.

 

Under the test conditions, juniper berry oil induced moderate skin irritation in rabbits.

This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study.

Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Juniper, Juniperus communis, ext.
EC Number:
283-268-3
EC Name:
Juniper, Juniperus communis, ext.
Cas Number:
84603-69-0
Molecular formula:
Not applicable for UVCB
IUPAC Name:
Juniper, Juniperus communis, ext.
Test material form:
other: clear liquid
Details on test material:
- Name of test material (as cited in study report): JUNIPER BERRY OIL
- Physical state: Clear liquid

Test animals

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

Administration / exposure

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

Results and discussion

Preliminary study:
Not applicable
Effect levels
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

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, 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.