Registration Dossier
Registration Dossier
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EC number: 219-669-7 | CAS number: 2494-89-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.11.1989 - 01.12.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(p-aminophenyl)sulphonyl]ethyl hydrogensulphate
- EC Number:
- 219-669-7
- EC Name:
- 2-[(p-aminophenyl)sulphonyl]ethyl hydrogensulphate
- Cas Number:
- 2494-89-5
- Molecular formula:
- C8H11NO6S2
- IUPAC Name:
- [2-(4-aminobenzenesulfonyl)ethoxy]sulfonic acid
- Details on test material:
- p-Base Ester
Batch: Op. 1299 / 1989
CoA: 1196 dated 25.09. 1989
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
- Weight at study initiation: 3060g - 3690g
- Housing: single
- Diet (e.g. ad libitum): Standard food Altromin 2123 Haltungsdiät - Kaninchen and hay
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 per day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution.
At 24 and 72 hours, eyes were stained with Fluorescein-sodium-solution (0.01%) and investigated under UV-light by means of a 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:
- 2.9
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 2.9
- Score:
- 24
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification according 83/467/EWG: R41 - risk of serious damage to eyes
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