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EC number: 945-878-4 | CAS number: 93165-40-3
- 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
Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, non-GLP, 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:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Standard acute method
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-300 g
- Fasting period before study: Overnight
- Housing: Animals were individually housed.
- Diet: Commercial diets, ad libitum
- Water, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
DOSAGE PREPARATION:
Test substance was prepared as 50% (w/v or v/v) solutions or suspensions in corn oil. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days.
- Necropsy of survivors performed: Yes; gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination. - Statistics:
- LD50 was calculated according to Horn's method (Horn, 1956).
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain.
- Gross pathology:
- At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.
- Executive summary:
In an acute oral toxicity study, group of 10 Sprague-Dawley rats were given a single oral dose of Galbanum at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.
No mortality was observed. Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain. At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.
Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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, group of 10 Sprague-Dawley rats were given a single oral dose of Galbanum at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.
No mortality was observed. Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain. At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.
Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the available information, the registered substance is:
- not classified according to the Regulation (EC) No. 1272/2008 and GHS.
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), the registered substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.
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.
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