Registration Dossier

Diss Factsheets

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
not specified
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide
EC Number:
227-930-1
EC Name:
4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide
Cas Number:
6041-94-7
Molecular formula:
C23H15Cl2N3O2
IUPAC Name:
4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-N-phenyl-2-naphthamide
Test material form:
solid: nanoform, no surface treatment
Details on test material:
Name of test material (as cited in study report): Permanentrot FRR CM 79883
Analytical purity: technically pure

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- Weight at study initiation: 1.5-2.0 kg
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, #5, #6 each
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritant / corrosive response data:
Iris, cornea and chemosis score were 0 for all six animals at all time points (1, 7, 24, 48 and 72 h after removal of the test item). A redness of the conjunctiva was observed at the 7 h -reading in animal #2, 3 and 4 (score1). It persisted up to 24 h (animal 2) and 48 h (animal 3 and 4) with a score of 1.
No discharge was observed in any animal at any time point.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is very slightly irritating to the eyes under the test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. 3/6 animals showed a conjunctiva redness score of one, 7 and 24 h after application, the effect being fully reversible within 72 h. No other effects were observed.
The slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. Only slight effects could be observed (conjunctiva redness score of 1 in 3/6 animals after 7 and 24 h, which was fully reversible within 72 h). No other effects could be observed in any animal.

Categories Display