Registration Dossier
Registration Dossier
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EC number: 485-320-2 | CAS number: 221667-31-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jun - 24 Jun 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 9 Oct 2017
- Deviations:
- yes
- Remarks:
- No use of analgesics.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 485-320-2
- EC Name:
- -
- Cas Number:
- 221667-31-8
- Molecular formula:
- C18H18N205S
- IUPAC Name:
- N-[4-(cyclopropylcarbamoyl)benzenesulfonyl]-2-methoxybenzamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany.
- Age at study initiation: Young adults (actual ages not stated)
- Body weight at study initiation: 2.9 - 3.8 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding, changed at least twice weekly and animals were regularly transferred to clean cages.
- Diet: Approx. 100 g/animal/day standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, 59494 Soest, Germany) .
- Water: Tap water from polycarbonate bottles, ad libitum.
- Acclimatization period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Room temperature: 20 ±3 °C
- Air humidity: 50 ± 25 %
- Air changes (per hr): approx. 10
- Light/ Dark cycle (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2005-06-21 To 2005-06-24
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as control
- Amount / concentration applied:
- - Amount (s) applied: 0.1 g (pulverized test substance).
- Duration of treatment / exposure:
- Single application without washing.
- Observation period (in vivo):
- 72 h
Reading time points: 1,24,48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eye was not rinsed for at least 24 hours following instillation.
SCORING SYSTEM: Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Conjunctival redness, grade 2 was the only finding 1 h after treatment in all 3 animals. However, reversibility was evident and conjunctival redness grade 1 was observed in all 3 animals at 24 h post-treatment and in one animal only at 48 h. Ocular effects were completely resolved in all animals at 72 h.
- Other effects:
- There was reduced food intake in 2/3 test animals which was considered to be not test substance related by the investigators.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The study was performed in accordance to OECD TG 405 under GLP conditions and is considered reliable. The test substance was determined to be non-irritating.
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