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Registration Dossier
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EC number: 202-180-8 | CAS number: 92-70-6
Eye irritation
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: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-hydroxy-2-naphthoic acid
- EC Number:
- 202-180-8
- EC Name:
- 3-hydroxy-2-naphthoic acid
- Cas Number:
- 92-70-6
- Molecular formula:
- C11H8O3
- IUPAC Name:
- 3-hydroxynaphthalene-2-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): BONS TTR
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG breeding colony,
- Weight at study initiation: 2.7 - 3.9 kg
- Housing: singla cage
- Diet (e.g. ad libitum): rabbit diet Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 100 mg test substance mixed with 0.1 ml polyethylene glycol 400
- Duration of treatment / exposure:
- 24 hours. Thereafter the eyes were rinsed with physiological saline (37°C)
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were evaluated at: 1, 24, 48 and 72 hours and on days 7 and 14 after application. Grades attained at 24, 48 and 72 hours after application were included in the mean gradings of ocular lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1 and 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- All findings covered by the scoring system were fully reversible within the observation period of 14 days.
Additional response date:
Discharge: from 1 to 72 h post application, fully reversible within 7 days
Nicitating membrane: partial gray discoloration, fully reversible within 14 days
Cornea surface: uneven, not reversible within the observation period of 14 days
Corneal vascularization: starting at day 7, advanced at day 14, not reversible within the observation period of 14 days - Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In view of the corneal lesions still evident at the end of the observation period (14 days) and considered to be irreversible the test substance was considered to pose a risk of serious damage to eyes.
- Executive summary:
3-Hydroxy-2-naphthoic acid was tested for eye irritation according to OECD Guideline 405 and in compliance with GLP. Each of three New Zealand White rabbits was treated by administration of a single dose of 100 mg test substance mixed with polyethylene glycol 400 (0.1 ml) to the conjunctival sac of one eye. Eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours and on days 7 and 14 after application. At 1 hour after application, swelling and conjunctival injection as well as secretion (clear, tinted by the test substance) were observed in all animals. At 24, 48 and 72 hours, conjunctivitis and diffuse corneal opacities were found. One animal showed iritis at 24 and another at 48 hours. At 7 and 14 days after the application, uneven corneal surface and/or corneal vascularization were seen in all animals. In view of the corneal lesions still evident by 14 days post application and considered to be irreversible the test substance was considered to pose a risk of serious damage to eyes.
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