Registration Dossier
Registration Dossier
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EC number: 269-047-4 | CAS number: 68186-85-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77377.
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:
- 1982-11-29 to 1982-12-06
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment (TS identity)
Data source
Reference
- Reference Type:
- other: TSCA Document
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US EPA §163.81-5, Federal Register 43, 163, 22. Aug. 1978
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- TK 13005
- IUPAC Name:
- TK 13005
- Details on test material:
- - Name of test material (as cited in study report): TK 13005
Physical state: solid
Batch No.: 41635-121081
no further details
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoering AG, CH- 4414, Fuellingsdorf, Switzerland
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: ad libitum, Rabbit food, NAFAG, No 814 Tox, NAFAG Grossau, Switzerland
- Water: ad libitum
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
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:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Additionally, in 3 rabbits the treated eye was flushed 30 sec after application with 10 mL sterile physiological saline. One of these rabbits showed slight conjunctivae redness after 24 h but not at later time points (no effects on cornea and iris). No further effects in any of the other rabbits were observed.
Applicant's summary and conclusion
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