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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- 10 females (+5 controls). When fewer than 20 test and 10 control guinea pigs have been used,its not possible to conclude that the test substance is sensitizer
- Principles of method if other than guideline:
- Group size: main study: 10 females (+5 controls)
preliminary study: 3 females
Dose levels:
intradermal induction: 0.1% physiological saline
epicutaneous induction: 40% petrolatum
epicutaneous challenge: 40% petrolatum - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Using available in vivo data. LLNA- method was not available in in 1994.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Guideline: Directive 92/69/EEC, method B.6. (1992)
Species: Hartley guinea pigs
Strain: Crl:(HA)BR
Group size: main study: 10 females (+5 controls)
preliminary study: 3 females
Test substance: DA 060492
Batch: type 210741, 03.02.94.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0,1%
- Adequacy of induction:
- not specified
- Vehicle:
- petrolatum
- Concentration / amount:
- 40%
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Vehicle:
- petrolatum
- Concentration / amount:
- 40%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- DA 060492, suspended in physiological saline, was applied to 10 guinea pigs in the Magnusson and Kligman "maximisation test".
- Challenge controls:
- 1,4-phenylenediamine was used as positive control substance. Freund’s complete adjuvant was used.
- Positive control substance(s):
- yes
- Remarks:
- 1,4-phenyldiamine
Results and discussion
- Positive control results:
- Not specified.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Following challenge exposure "well defined erythema" or "severe erythema and/or oedema" were observed in all animals (10/10) after 24 h and / or 48 h. One negative control (1/5) also showed a reaction.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on these results DA 060492 (infigofera tinctoria leaf powder) is a sensitizer following skin contact in this maximisation test.
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