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Diss Factsheets
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EC number: 948-256-0 | 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
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:
- 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- LI13019F1 (Serratrin) is a unique composition of acidic and non-acidic components derived from an aqueous ethanol extract of B serrata gum resin. The gum resin was extracted with aqueous ethanol, and the concentrated extract was subjected to phase separation to obtain Boswellia nonacidic resin extract and the acidic extract containing BAs. Two parts of the BAs containing resin extract and one part of the nonacidic resin extract were combined, milled, and sieved using a unique process to obtain LI13019F1. To maintain the quality and batchto-batch consistency, LI13019F1 was standardized to contain at least 30% of total BAs with not less than 5% KBAs.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 9-week-old female (n = 5) Wistar rats.
Wistar rats were purchased from Vivo BioTech Limited (Hyderabad, India). The experimental animals were specific pathogen-free. The animals were acclimatized to the laboratory conditions for 7 days and maintained in a controlled environment (21C + 2C, 40%-70% relative humidity, and 12 hour/12 hour light/dark cycle). During the study
period, the animals were allowed free access to a standard diet and bottled mineral water. The Institutional Animal Ethics Committee approved the experimental protocols. The animal care operating procedure followed the guidelines of the Committee for the Purpose of Control and Supervision of Experiments on Animals, India - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- CMC-Na (0.5% wt/vol)
- Details on oral exposure:
- a limit test was performed utilizing 9-week-old female (n = 5) Wistar rats. LI13019F1 suspended in CMC-Na (0.5% wt/vol) was administered by gavage at a dose of 2,000 mg/kg body weight (BW).
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- Before the test item administration, the animals were observed for clinical signs. The animals were monitored for morbidity/mortality or clinical signs at 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours after the test item administration. Thereafter, all animals were observed once daily for 14 consecutive days. Body weights were measured once a week during the observation period. The vital organs and tissues were subjected to gross pathological examinations following CO2 euthanasia on day 15.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- The animals did not show any clinical signs of toxicity during the 15-day follow-up period
- Body weight:
- The animals did not show abnormal changes in their body weights during the observation period
- Gross pathology:
- A gross pathological examination also did not reveal any abnormalities
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a publication, Laila Nutraceuticals R&D Center made a toxicological assessment of a standardized Boswellia serrata Gum Resin Extract.
The acute oral toxicity study was performed according to OECD 425 guideline, followinf Good Laboratory Practices.
In this study, the extract show no acute oral toxicity (LD50>2000mg/kg bw/day).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
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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