Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 283-268-3 | CAS number: 84603-69-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Juniperus communis, Cupressaceae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
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.
- 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.
None
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.