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.
Acute Toxicity: dermal
Administrative data
- 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
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 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- not specified
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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
Administration / exposure
- 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
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
Applicant's summary and conclusion
- 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.
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