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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
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
- 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
- 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.
Reference
None
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
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.