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Toxicological information

Eye irritation

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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:
other: OECD-guideline and GLP-compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
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

Constituent 1
Chemical structure
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

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:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 h
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria, the test substance is considered to be "not irritating" to the rabbit eye.