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EC number: 946-037-4 | CAS number: -
- 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 (read-across with Pepper black oil, equivalent or similar to OECD 401, non-GLP, K, Rel.2)
Acute toxicity, dermal in rats: LD50 > 2000 mg/kg bw (OECD 402, GLP, K Rel. 1)
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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Rats were given a single oral dose of test substance at 5000 mg/kg bw and then observed for 14 days.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Description: Clear light yellow liquid
- Date of receipt: 30 May 1972 - 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)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/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.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Lethargy soon after test substance administration and animals recovered 24 h later
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272 -2008.
- 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 Black pepper oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.
No mortality was observed. Lethargy soon after test substance administration and animals recovered 24 h later. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.
Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according the Regulation (EC) N° 1272 -2008.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Further information is included as attachment to Section 13] - Reason / purpose for cross-reference:
- read-across source
- 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: Lethargy soon after test substance administration and animals recovered 24 h later
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, oral LD50 of pepper black oil is higher than 5000 mg/kg bw in rats. Therefore the registered substance Olibanum oil is not classified according to the Regulation (EC) N° 1272-2008.
- 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 Black pepper oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.
No mortality was observed. Lethargy soon after test substance administration and animals recovered 24 h later. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.
Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats. Therefore, based on these results, the registered substance Olibanum oil is not classified according the Regulation (EC) N° 1272-2008.
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Adequate for hazard assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP guideline study
Additional information
Acute toxicity: via oral route
In an acute oral toxicity study (limit test), groups of Sherman-Wistar rats (5/sex/dose) were given a single oral dose of the Pepper black oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days. No mortality was observed. Lethargy soon after test substance administration and animals recovered 24 h later. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.
Acute toxicity: via dermal route
In an acute dermal toxicity study performed according to the OECD Guideline 402 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was applied onto the intact skin of 3 female Sprague Dawley rats under occlusive conditions for 24 hours. Animals were then observed for mortality, dermal reactions, body weight changes and clinical signs of toxicity for 14 days.
No mortality occurred during the study. No systemic clinical signs related to the administration of the test substance were observed. Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Days 4 and 5. Dryness of the skin and scab were noted in two treated animals (2/3) between Days 4 and 5. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.
Under the test conditions, the dermal LD50 of the test substance is >2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008. As no mortality and no adverse clinical signs were observed at 2000 mg/kg bw, it is anticipated that the registered substance is also not classified according to the GHS. No signal word or hazard statement is required.
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 on Pepper black oil, the registered substance is:
- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw
Acute toxicity via Dermal route:
Based on the information available on the registered substance, it is not classified according to the Regulation (EC) No. 1272/2008 as LD50>2000 mg/kg bw.
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):
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 (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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