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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 08 APR 1980 to 11 APR 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: FDA guideline (minor deviations from OECD guideline)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: (Federal Register Vol. 38, no. 187, p. 27019, 1973)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

Test material

Constituent 1
Reference substance name:
N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide
EC Number:
277-873-1
EC Name:
N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide
Cas Number:
74441-05-7
IUPAC Name:
N-(4-carbamoylphenyl)-4-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)benzamide

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in-house breeding colony
- Housing: single
- Diet: ERKA 8300 (Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg pasted in 0.4 ml 0.9 % physiol. saline
Duration of treatment / exposure:
24 h after exposure eyes were washed with physiological saline.
Observation period (in vivo):
72 h with observation time points at 1, 7, 24, 48 and 72 h after application.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize Scale.

TOOL USED TO ASSESS SCORE: loupe / fluorescein (at 48 and 72 h reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1-#5 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
individual animal data at time point 1/7/24/48/72 h for animal #1-#6

cornea: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0,
0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0

iris: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0,
0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0

conjunctivae redness: 0/0/0/0/0, 1/0/0/0/0, 1/1/0/0/0,
1/0/0/0/0, 1/0/0/0/0, 1/1/1/0/0

chemosis: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0,
0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
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 pasted in physiological saline were applied to one eye of six animals each. 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 5/6 animals after 1 h, in 2/6 animals after 7 h and only in 1/6 animals at 24 h reading, the effect was was fully reversible within 48 h). No other effects could be observed in any animal.