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EC number: 284-854-1 | CAS number: 84988-66-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lawsonia inermis, Lythraceae.
- 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
An acute oral toxicity study of Henna was performed in the Rat according to the OECD Guideline N°401 (1981).
The calculated oral median lethal dose was > 2000 mg/kg bw. Other studies support this result. The other oral toxicity study informs that LD50 is 2000mg/kg bw. And LD50 is 570 -2000mg/kg bw for active substance (Lawsone, HNQ)
An acute dermal toxicity: Median lethal dose for Henna was > 2000 mg/kg bw, even 5000 mg/lkg bw. Lawsonia inermis showed no irritative potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity under the experimental conditions.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: SCCS/1511/13
- Adequacy of study:
- key study
- Study period:
- na
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- not specified
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- Not specified
- Clinical signs:
- other: Not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The calculated oral median lethal dose was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- A study was performed in rat according to the OECD Guideline N°401 (1981). Quality of database is acceptable.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: SCCS/1511/13
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Duration of exposure:
- 24h
- Doses:
- not specified
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute dermal toxicity study of Henna Rot was conducted in the Wistar Rat according to OECD Guideline 402 (1987). Median lethal dose for Henna Rot was > 2000 mg/kg bw.Lawsonia inermis showed no irritative potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity under the experimental conditions.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: Journal of Advances in Biotechnology, 2016
- Adequacy of study:
- key study
- Study period:
- na
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- not specified
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Fresh whole plant samples were obtained from Jerantut, Pahang, Malaysia. The leaves were separated from the plant and dried at a temperature between 25°C to 30°C for three to five days. The dried leaves were ground into powder form using a grinder and kept in a refrigerator at 4°C. The powdered leaves were then macerated with 97% ethanol in a flask. The mixture was left in a water bath at temperature between 55°C to 60°C for one day to allow the chemicals in the leaves to dissolve in the ethanol solution. The ethanol phase was isolated from the mixture by filtration followed by evaporation using a rotor paper evaporator then dried using freeze dryer for one day. The diluted solutions were kept in the refrigerator for later use. The leaf extract was mixed with white soft paraffin (10%).
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- the rats were weighed and assigned randomly in polypropylene plastic cages, where one rat was placed in each cage with wood chips for bedding and housed in an animal room with controlled conditions involving these parameters; temperature (22±2°C), humidity (55±10%) and lighting (12 hours light/dark) in the animal house.
- Vehicle:
- paraffin oil
- Duration of exposure:
- The application of extract in acute toxicity study occurred once
- Doses:
- In acutedermal toxicity studies, the toxic effects of the ethanolic leaf extract of L. inermis in Sprague Dawley rats were examined at dosages of 2000 and 5000 mg/kg body weight for a period of 14 days for acute dermal toxicity study.
- No. of animals per sex per dose:
- 20 /female
- Control animals:
- not specified
- Details on study design:
- The duration of this study was 14 days. Each group underwent application of the extract once at day 1 and sacrificed at day 14 of the experimental period.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 - <= 5 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- No mortality
- Clinical signs:
- other: In the treated groups, in the first 6 hours after applying the extract rapid heartbeat was observed, but then normalized. This may be due to the stress of handling.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of this study suggest that ethanolic extracts of L. inermis do not cause any apparent in vivo toxicity. No death or signs of toxicity were observed in rats treated with the extracts at doses of 5000 and 2000 mg/kg (acute toxicity study),
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- An acute dermal toxicity studies of Henna was conducted in the Rat according to OECD Guideline 402. Quality of database is acceptable.
Additional information
Justification for classification or non-classification
Acute oral toxicity studies; Median lethal dose for Henna Rot was > 2000 mg/kg bw.
Acute dermal toxcicity studies; MEdian lethal dose for Henna was 2000 -5000mg/kg bw.
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