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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-974-6 | CAS number: 894-86-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 9 February to 16 February 1987
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- [2,2'-bi-1H-indole]-3,3'-diol
- EC Number:
- 229-449-2
- EC Name:
- [2,2'-bi-1H-indole]-3,3'-diol
- Cas Number:
- 6537-68-4
- IUPAC Name:
- 2,2'-biindole-3,3'-diol
- Details on test material:
- - Name of test material (as cited in study report): Indigo white 50% paste
- Molecular formula (if other than submission substance): C16H12N2O2
- Molecular weight (if other than submission substance): 264.29
- Smiles notation (if other than submission substance): C4=CC=C2C(=C4)C(O)=C(C1=C(O)C3=C(N1)C=CC=C3)N2
- InChl (if other than submission substance): InChI=1S/C16H12N2O2/c19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14/h1-8,17-20H
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: preparation
- Physical state: black paste
- Lot/batch No.: Mix 39
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.86 kg
- Housing: single
- Diet: Rabbit maintenance diet, Preston Farmers Ltd. UK ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 19
- Humidity (%): 45 to 50
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 9 To: 16. February 1987
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48, 72 hours + 7 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- SCORING SYSTEM: see Tab. 1 + 2
Index
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 19
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 85
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 66
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 41
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- A dulling of the normal lustre of the corneal surface was noted one hour after treatment. Opalescent opacity was noted at subsequent 24, 48, and 72-hour observations. The cornea appeared normal on day 7.
Iridal inflammation was noted one hour after treatment and subsequent 24, 48, and 72-hour observations. The iris was normal on day 7.
Moderate conjunctival irritation was noted one hour after treatment, which increased to severe conjunctivitis at subsequent 24 and 48-hour observations. The conjunctival irritation egressed to minimal at the 72-hour observation. No conjunctival irritation was noted on day 7. - Other effects:
- Areas of blue staining of the iris and conjunctival membranes were noted during the study
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- The test item "indigo white 50% paste" is irritating to eyes. This is due to the alkaline ingredient in the preparation.
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.
