Registration Dossier
Registration Dossier
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EC number: 432-520-2 | CAS number: 232938-43-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 432-520-2
- EC Name:
- -
- Cas Number:
- 232938-43-1
- Molecular formula:
- C21 H20 N2 O6 S2
- IUPAC Name:
- 3-{[(4-methylbenzenesulfonyl)carbamoyl]amino}phenyl 4-methylbenzene-1-sulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 14 weeks (males), 15 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water (e.g. ad libitum): Community tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-24 °C
- Humidity (%):48-88 %
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volue or weight with unit): 0.1 g - Duration of treatment / exposure:
- unrinsed
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 1 male,
2 females - Details on study design:
- SCORING SYSTEM: numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after administration
Results and discussion
In vivo
Resultsopen allclose all
- 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
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.67. Slightly reddened and/or slight swelling of the conjunctivae, white solid remnants in eye or conjunctival sac were observed in all animals 1 and 24 hours after application as well as in one female at the 48-hour reading. Slight watery discharge was observed in the male and one female animal at the 1-hour reading. Slightly reddened sclera were observed in all animals at the 1-hour reading and in one female at the 24-hour reading.
- Other effects:
- - No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occuned.
- No staining of the treated eyes by the test article was observed.
- All animals gained normal body weight
Any other information on results incl. tables
Eye irritation scores: individual values
Animal No. |
Sex |
Evaluation interval |
Corneal opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||||
1 |
M |
1 h |
0 |
0 |
1 |
1 |
2 |
F |
0 |
0 |
1 |
1 |
|
3 |
F |
0 |
0 |
1 |
1 |
|
1 |
M |
24 h |
0 |
0 |
1 |
0 |
2 |
F |
0 |
0 |
1 |
0 |
|
3 |
F |
0 |
0 |
1 |
1 |
|
1 |
M |
48 h |
0 |
0 |
0 |
0 |
2 |
F |
0 |
0 |
0 |
0 |
|
3 |
F |
0 |
0 |
1 |
1 |
|
1 |
M |
72 h |
0 |
0 |
0 |
0 |
2 |
F |
0 |
0 |
0 |
0 |
|
3 |
F |
0 |
0 |
0 |
0 |
|
1 |
M |
24-72 h |
0 |
0 |
0.33 |
0.00 |
2 |
F |
0 |
0 |
0.33 |
0.00 |
|
3 |
F |
0 |
0 |
0.67 |
0.67 |
|
Mean (1-2-3) |
24-72 h |
0.00 |
0.00 |
0.44 |
0.22 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to EC regulation 1272/2008 and its amendments.
- Conclusions:
- Based upon the referred classification criteria, the test substance is considered to be "not irritating" to the rabbit eye.
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