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EC number: 403-080-9 | CAS number: 92484-48-5 BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
Toxicological information
Eye irritation
Currently viewing:
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:
- 1 988
- 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
- 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
Constituent 1
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.
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