Registration Dossier
Registration Dossier
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: 267-090-3 | CAS number: 67786-14-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Mar - 01 Apr 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate
- EC Number:
- 267-090-3
- EC Name:
- Sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate
- Cas Number:
- 67786-14-5
- Molecular formula:
- C17H12F3N3O4S.Na
- IUPAC Name:
- sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate
- 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:
- TEST ANIMALS
- Source: Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 2.7 kg, females: 3.0 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70% rh
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g / animal (left eye treated, right eye control)
- Duration of treatment / exposure:
- one treatment at 0 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 females, 1 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of corrosion observed. Swelling of conjuctivae was fully reversible within 24 h.
- Other effects:
- Light red to red staining (test item) of sclera and conjunctivae observed in all animals, fully reversible within 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause any signs of irritation or corrosion in rabbit eyes. The substance is classifiable according to the CLP Regulation.
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.
