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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:
1988-01-22 to 1988-02-26
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

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
Principles of method if other than guideline:
NA
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
EC Number:
403-080-9
EC Name:
Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
Cas Number:
92484-48-5
Molecular formula:
C16 H17 N3 O4 S .Na
IUPAC Name:
sodium 3-(2H-1,2,3-benzotriazol-2-yl)-5-(butan-2-yl)-4-hydroxybenzene-1-sulfonate
Details on test material:
- Name of test material (as cited in study report): FAT 75'309/A

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG; CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: By unique cage number and corresponding ear tags.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, rabbit maintenance diet , ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period: Four days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+ /- 3°C
- Humidity (%): 40-70 %
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (The test article was applied undiluted.)
Duration of treatment / exposure:
single application
Observation period (in vivo):
21days
Number of animals or in vitro replicates:
3 (1 female + 2 males)
Details on study design:
The eyes of the animals were observed 24 hours prior to test article administration.
The test article (0.1 g per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
233 male
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
234 male
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
235 female
Time point:
other: 24,48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
233 Male
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
234 Male
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(235 female)
Time point:
other: 24,48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
233 male
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
234 male
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
235 female
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
234 male
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
other: cumulative score
Basis:
animal #1
Remarks:
233 male
Time point:
other: 24, 48, 72 hours
Score:
4
Max. score:
13
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: cumulative score
Basis:
animal #2
Remarks:
234 male
Time point:
other: 24, 48, 72 hours
Score:
5.3
Max. score:
13
Reversibility:
not reversible
Irritation parameter:
other: cumulative score
Basis:
animal #3
Remarks:
235 female
Time point:
other: 24, 48, 72 hours
Score:
4.67
Max. score:
13
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: cumulative score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
4.65
Max. score:
13
Reversibility:
not reversible
Irritant / corrosive response data:
- The test item showed a primary Irritation score of: 4.3, when applied to the rabbit eye mucosa.
- In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
- Slight corrosion on the cornea was observed in all animals within 48 hours to 72 hours and 48 hours to 21 days.
Other effects:
- No acute toxic symptoms were observed In the animals during the test period, and no mortality occurred.
- The body weight gain of all rabbits was similar.
- Due to the results obtained, no macroscopic organ examination was indicated.

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: EU
Conclusions:
The test item was found to be severely damaging to the eyes, as corneal leasons were not reversible within 21 days in one of three treated rabbits.
Executive summary:

Sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in a primary eye irritation study according to OECD giudeline 405 and EU method B.5. The single dose of the test item (0.1 g per animal) was placed in the conjunctival sac of rabbit eyes. The test item was found to cause a primary irritation score of 4.3, when applied to the rabbit eye mucosa. The test item was found a mean cornea score of 1 (24/48/72 h), a mean iris score of 1 (24/48/72 h)

, a conjunctivae score of 2 (24,/48/72 h) and a chemosis score of 0.63 (24/48/72 h). No staining of the cornea and conjunctivae of the treated eyes by pigment or of test item was observed. Slight corrosion on the cornea was observed in all animals within 48- to 72 hours. The test item is severely damaging to rabbit eye, as irritation of one animal is irreversible within 21 days.