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.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: SCCNFP/0798/04
- Adequacy of study:
- supporting study
- Study period:
- na
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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.
- Reference substance name:
- (2R,3R,4S,5R,6S)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2S,3R,4S,5R,6R)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2R,3R,4S,5R,6R)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane
- Cas Number:
- 99638-59-2
- Molecular formula:
- C29H54O16
- IUPAC Name:
- (2R,3R,4S,5R,6S)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2S,3R,4S,5R,6R)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2R,3R,4S,5R,6R)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane
- Test material form:
- liquid - solid: mixture of
- Remarks:
- suspension : 2-hydroxy-1,4-napthoquinone in 0,5% aqueous methylcellulose
- Details on test material:
- 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose
Constituent 1
additive 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 2% suspension in 0.5% aqueous methylcellulose (0.5 ml)
- Controls:
- not specified
- Amount / concentration applied:
- The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to the left flank.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Cutaneous reactions were evaluated 1, 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3
- Details on study design:
- not specified
Results and discussion
In vivo
Results
- Irritation parameter:
- other: irritation
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: The substance could potential have provoked slight to moderate irritation
Applicant's summary and conclusion
- Conclusions:
- Orange staining due to the dye interfered with evaluation of erythema. No oedema was observed. The substance could potentially have provoked slight to moderate, but not severe irritation.
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