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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
The results of a Buehler test suggest that Lawsonia inermis exhibited no potential to induce dermal sensitization in Guinea pigs under the conditions used.
Active substance, Lawsone; studies on sensitisation are equivocal.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: SCCS/1511/13
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Using available in vivo data. LLNA- method was not available in 1990.
- Specific details on test material used for the study:
- Guideline:OECD 406
Species/strain:
Guinea pig/Dunkin Hartley
Group size:
Main study: 10 female animals in the control, 20 female animals in the test groups
Test substance: Henna Rot , Lawsonia Inermis Leaf Powder
Batch: 830.72
Purity: /
Route: Occlusive epicutaneous induction (50%) and challenge (50%)
Carrier: Petrolatum
GLP: Yes
Date: 1990 - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- One group of 20 animals received induction exposures of 0.5 ml at a concentration of 50% in petrolatum on the left flank on absorbent lint (approximately 15 mm x 35 mm) after removal of hair. The occlusive dressing was kept in place for 6 hours and the induction was repeated on the same site on days 7 and 14 for a total of three 6 h exposures. The skin was carefully examined approximately 24 h after each induction on days 1, 8 and 15.
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction exposures of 0.5 ml at a concentration of 50% in petrolatum on the left
flank on absorbent lint (approximately 15 mm x 35 mm) after removal of hair. - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5 ml test material (50% in petrolatum)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- The sensitizing property of the test substance was evaluated in a Buehler delayed contact hypersensitivity study using female albino Hartley guinea pigs. One group of 20 animals received induction exposures of 0.5 ml at a concentration of 50% in petrolatum on the left flank on absorbent lint (approximately 15 mm x 35 mm) after removal of hair. The occlusive dressing was kept in place for 6 hours and the induction was repeated on the same site on days 7 and 14 for a total of three 6 h exposures. The skin was carefully examined approximately 24 h after each induction on days 1, 8 and 15.
Challenge was performed on day 28 by application of 0.5 ml test material (50% in petrolatum) on an area of about 15 mm x 30 mm on the right left flank clipped free of hair held under occlusion for 6 h. Approximately 24 and 48 h after removal of the occlusive dressing, the skin reaction was evaluated and scored using a four-point scale. The individual reactions to the tests substance preparation at the challenge sites were compared between control and test animals. - Positive control substance(s):
- not specified
- Positive control results:
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge was performed on day 28 by applic ation of 0.5 ml test material (50% in petrolatum) on an area of about 15 mm x 30 mm on the right left flank clipped free of hair held under occlusion for 6 h.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Staining caused by the test substance preparation was observed after removal of the occlusive dressing. The study authors considered that this did not prevent evaluation of the treated skin in respect to erythema formation.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge was performed on day 28 by applic ation of 0.5 ml test material (50% in petrolatum) on an area of about 15 mm x 30 mm
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Staining caused by the test substance preparation was observed after removal of the occlusive dressing. The study authors considered that this did not prevent evaluation of the treated skin in respect to erythema formation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Staining caused by the test substance preparation was observed after removal of the occlusive dressing. The study authors considered that this did not prevent evaluation of the treated skin in respect to erythema formation. No treatment-related reaction was noted on the treated skin in any animals (0/20)
The results suggest that Lawsonia inermis exhibited no potential to induce dermal sensitization in Guinea pigs in the Buehler test under the conditions used. However, skin staining may have compromised evaluation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Not classified skin sensitisation. The results of a Buehler test suggest that Lawsonia inermis exhibited no potential to induce dermal sensitization in Guinea pigs under the conditions used.
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