Registration Dossier
Registration Dossier
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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.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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
Data source
Reference
- Title:
- Scientific Committee on Consumer Safety Opinion on Lawsonia Inermis (Henna) Colipa no C169
- Author:
- SCCS
- Year:
- 2 013
- Bibliographic source:
- ISBN 978-92-79-30118-6
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lawsonia inermis, ext.
- EC Number:
- 284-854-1
- EC Name:
- Lawsonia inermis, ext.
- Cas Number:
- 84988-66-9
- Molecular formula:
- na
- IUPAC Name:
- Lawsonia inermis, ext.
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the test substance (approximately 58 mg) was instilled into the conjunctival sac of the right eye
- Duration of treatment / exposure:
- The test substance was not washed out.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Guideline: OECD guideline 405 (1987)
Species/strain: Rabbit/New Zealand White
Group size: 1 male and 2 females
Test substance: Henna Rot ,Lawsonia Inermis Leaf Powder
Batch: 830.72
Concentration: green powder ‘as is’
Route: instillation in the conjunctival sac of the right eye
Observation period: 7 days
GLP: Yes
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- >= 17 - <= 17
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 15.7 - <= 15.7
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 10 - <= 10
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 2.7 - <= 2.7
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- >= 0 - <= 0
- Reversibility:
- fully reversible
- Other effects:
- No findings of the cornea occurred. Transient inflammation of the iris and moderate conjunctival irritation were observed up to a maximum of 48 and 72 hours, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Lawsonia inermis was slightly and transiently irritating to the eyes of 3 New Zealand White rabbits. (Group size 3 rabbit)
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