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.
Endpoint summary
Administrative data
Description of key information
Two Magnusson & Kligman studies show that Indigofera tinctoria leaf powder (DA 060492) is a contact allergen in this model. The third study considered Indigofera leaf powder is not sensitizer, but histopathological examination following treatment wtih indigofera tinctoria leaf powder showed some dermal changes in animals.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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. - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0,1%
- Adequacy of induction:
- not specified
- Vehicle:
- petrolatum
- Concentration / amount:
- 40%
- Adequacy of induction:
- not specified
- 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
- Positive control results:
- Not specified.
- 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
- 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: SCCS /1439/11
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- Only 10 animal and 10 controls
- Principles of method if other than guideline:
- Dose levels: intradermal induction: 0.25% aqueous solution
epicutaneous induction: 12.5% aqueous solution
epicutaneous challenge: 12.5% aqueous solution - 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 1995.
- Specific details on test material used for the study:
- DA 060492, (Indigofera tinctoria leaf powder) suspended in distilled water, was applied to 10 guinea pigs in the Magnusson and Kligman "maximisation test".
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0,25%
- Adequacy of induction:
- not specified
- Vehicle:
- water
- Concentration / amount:
- 12,5
- Adequacy of induction:
- not specified
- No.:
- #1
- Vehicle:
- water
- Concentration / amount:
- 12,5%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- DA 060492, suspended in distilled water, was applied to 10 guinea pigs in the Magnusson
and Kligman "maximisation test". - Positive control substance(s):
- yes
- Remarks:
- sodium lauryl sulphate
- Positive control results:
- Not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- not specified
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- slight to intense erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Not specified
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- moderate to intense erythema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- 8 of 10 guinea pigs showed slight to intense erythema following challenge exposure after 24 h. 48 h after challenge, moderate to intense erythema were scored in 5 animals.
Based on these results, DA 060492 (Indigofera tinctoria laf powder) induced delayed contact hypersensitivity.
Referenceopen allclose all
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The product is classified.
Study one: 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.
Study 2: 8 of 10 guinea pigs showed slight to intense erythema following challenge exposure after 24
h. 48 h after challenge, moderate to intense erythema were scored in 5 animals.
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