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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
performed prior to guideline and GLP implementation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register Vol. 38, No. 187, p 27019, 1973
Deviations:
not specified
GLP compliance:
no
Remarks:
performed prior to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-3'-nitro-2-naphthanilide
EC Number:
205-209-2
EC Name:
3-hydroxy-3'-nitro-2-naphthanilide
Cas Number:
135-65-9
Molecular formula:
C17H12N2O4
IUPAC Name:
3-hydroxy-N-(3-nitrophenyl)-2-naphthamide
Test material form:
solid
Details on test material:
purity: 99.7%
Product number HKAG 155

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, company breeding colony
- Housing: single cage
- Diet (e.g. ad libitum): Mischfutter ERKA 8300, Robert Koch oHG/Hamm, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right untreated eye of each animal served as negative control
Amount / concentration applied:
100 mg per eye
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

SCORING SYSTEM: Appraisal of the Safety of Chemieals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p 51, 1975
- Method of calculation: mean of 24/48/72 h

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Fluorescein-Sodium, magnifier

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But moderate degree of severity and signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But moderate degree of severity and signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But moderate degree of severity and signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal: # 1-6 each
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility inapplicable due to missing effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h. But signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.
Irritation parameter:
chemosis score
Basis:
animal: # 1-6 each
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
mean scores of animal # 1 / 2 / 3 / 4 / 5 / 6:

Cornea: 0.7 / 0.7 / 1.0 / 2.0 / 1.7 / 0.7
Iris: 0.0 / 0.0 / 0.0 / 0.0 / 0.0 / 0.0
Conjunctivae
- redness: 2.0 / 2.0 / 2.0 / 2.3 / 2.0 / 2.0
- chemosis: 0.3 / 0.3 / 0.3 / 0.3 / 0.3 / 0.3

Mean scores of single rabbits for cornea and conjunctivae redness exeed the threshold for classification (Cat 2).

Due to the shortened observation period of 72 h some effects were not fully reversible in single rabbits within the observation period. However moderate degree of severity and signs of recovery in the entire group suggest, that full reversibility would occur within a prolonged observation period of 21 days.

Based on these findings the test item meets criteria for classification according to Regulation (EC) No 1272/2008: Category 2, H319: Causes serious eye irritation
Executive summary:

The substance was tested for eye irritation according to FDA-guideline (Vol. 38, Nr. 187, S. 27019, 1073). The left conjunctival sacs of 6 SPF-Albino-Himalayan rabbits were treated with 100 mg of the test item. The right untreated eyes served as controls.

According to FDA guideline the substance is moderately eye irritating.