Registration Dossier
Registration Dossier
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EC number: 944-439-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Brown 188:2 - Similar Substance 01
- IUPAC Name:
- Acid Brown 188:2 - Similar Substance 01
- 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:experimental breeder Extertal 1
- Weight at study initiation:1.9 kg
- Housing:individual cage
- Diet : "mummel Z" ad libitum
- Water : ad libitum
- Acclimation period:7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%):40%
- Photoperiod : 12 hours cycle dark/light
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : single injection 100 µL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24, 48, 72 and 8 days
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, at the end of exposure period, with saline solution.
SCORING SYSTEM: cornea, iris, conjunctiva
TOOL USED TO ASSESS SCORE: fluoresceine, ophthalmoscope.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- ca. 4.6
- Max. score:
- 110
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- Not irritating on rabbit eye
- Executive summary:
The substance was tested for eye irritation according to Federal Regulations, Title 16 , Section 1500.41 . The value of the irritation was = 4.6 (not irritant), but all parameters return to normal value after 8 days.
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