Registration Dossier
Registration Dossier
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EC number: 249-020-3 | CAS number: 28443-50-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1984
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:
- 2-amino-5-chlorophenol
- EC Number:
- 249-020-3
- EC Name:
- 2-amino-5-chlorophenol
- Cas Number:
- 28443-50-7
- Molecular formula:
- C6H6ClNO
- IUPAC Name:
- 2-amino-5-chlorophenol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: no data
- Weight at study initiation: 2.9 - 3.5 kg
- Housing: individually
- Diet: Altromin 2123 ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- other: untreated eye of test animal
- Amount / concentration applied:
- 100 mg test substance in0.07 ml polyethylene glycol 400
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were rinsed with physiological saline 24 hours after instillation.
Eyes were inspected for integrity before the testing. A solution of fluorescein, sodium salt (0.01%) was dropped into the eye. Then the cornea was investigated using UV radiation 24 hours before application. Afterwards eyes were rinsed.
24 and 72 hours after application eyes were examined for integrity in the same manner.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 0-7 d
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 0-7 d
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0-7 d
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 0-7 d
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study 2-amino-5-chlorophenol is irritating to the eye.
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