Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
yes
Remarks:
- known differences between EU, and EPA interpretation of OECD method (e.g. minimal positive response for corneal opacity is for EPA score 1, for OECD not specified and for EU mean 24 - 72 h score in two or more animals of ≥ 2 and < 3.0.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxybenzamide
- Analytical purity: 97.4 %
- Lot/batch No.: 08466/0013

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany. female albino rabbits (strain Crl:KBL(NZW)BR
- 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
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:

- Both eyes of each animal were examined and included fluorescein examination a day before treatment.
REMOVAL OF TEST SUBSTANCE
- The eye was not rinsed for at least 24 hours following instillation.
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified