Registration Dossier
Registration Dossier
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EC number: 283-892-6 | CAS number: 84775-63-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Indigofera tinctoria, Leguminosae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: SCCS opinion/ 1439/11
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- SCCS Opinion on Indigofera tinctoria COLIPA no C170
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 012
- Bibliographic source:
- 978-92-79-30776-8
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Indigofera tinctoria, ext.
- EC Number:
- 283-892-6
- EC Name:
- Indigofera tinctoria, ext.
- Cas Number:
- 84775-63-3
- Molecular formula:
- n/a
- IUPAC Name:
- Indigofera tinctoria, ext.
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Guideline: OECD 404 (1992)
Species: New Zealand white rabbits
Group size: 3 females
Test substance: DA 060492 (Indigofera tinctoria leaf powder)
Batch: type 210741, 03.02.94.
Purity: /
Dose levels: approx. 80 mg/cm²
Route: dermal
Exposure: 4 h
GLP: in compliance
Date: 1994 - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- A cellulose patch with 0.5 g of DA 060492 was spread over approx. 6 cm² and fixed with a
non-irritating tape. Animals were examined for erythema/eschar and oedema as well as for
local and systemic signs: 1, 24, 48 and 72 h after patch removal.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- < 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All animals revealed very slight oedema and erythema (score 1) after 1 h. Scoring at all further time-points was negative for all parameters. Indigo powder is considered as non-irritating to the skin in this test.
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