Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Eye irritation
Administrative data
- Endpoint:
- eye 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
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- not specified
- Principles of method if other than guideline:
- DA 060492 was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second. The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp. The left eye served as the control.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- Group size: 3 females
Test substance: DA 060492 (Indigofera tinctoria leaf powder)
Batch: type 210741, 03.02.94
Purity: /
Dose levels: 47, 73, 71 mg, applied to animals 1, 2, and 3 respectively
- Duration of treatment / exposure:
- The sample was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second.
- Observation period (in vivo):
- The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- DA 060492 was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second. The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp. The left eye served as the control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2,3
- Time point:
- other: 1 h
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 6 d
- Reversibility:
- not reversible
- Remarks on result:
- other: not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- other: Redness
- Basis:
- animal: 1,2,3
- Time point:
- other: 1 h
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: Not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 6 d
- Reversibility:
- not reversible
- Remarks on result:
- other: Not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2
- Time point:
- other: 6 d
- Reversibility:
- fully reversible
- Remarks on result:
- other: not specified
- Remarks:
- Qualitative results reported
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Redness and chemosis were observed in 3 animals each 1 h after exposure to Indigofera ticntoria leaf powder(DA 060492) .
No alterations of cornea and iris were observed at this time-point, but scoring at later timepoints revealed corneal opacity in 2 animals. Redness and chemosis remained for several hours, and aggravated occasionally. Additional scoring after 6 and 8 days revealed no corneal opacity, but conjunctival redness and chemosis remained for 6 days in one animal.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
