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EC number: 278-770-4 | CAS number: 77804-81-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 09 JUN 1981 to 12 JUN 1981
- Reliability:
- 1 (reliable without restriction)
- 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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register Vol. 38, nr. 187, p. 27019, 1973)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
Test material
- Reference substance name:
- 2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- EC Number:
- 278-770-4
- EC Name:
- 2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- Cas Number:
- 77804-81-0
- Molecular formula:
- C36H32N10O8
- IUPAC Name:
- 2,2'-[Ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- Test material form:
- solid: nanoform
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: in-house breed collony
- Housing: single
- Diet: EKRA 8300, Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum
Test system
- Vehicle:
- other: polyethylenglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg pasted in 0.23 ml polyethylenglycol 400 - 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 and #4 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2, #3 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not relevant since no effect
- 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 1/7/24/48/72 h for animal #1-#6
cornea: 1/0/0/0/0, 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: 1/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0,
0/0/0/0/0, 1/0/0/0/0, 1/0/0/0/0
conjunctivae redness: 1/1/1/1/0, 1/1/1/0/0, 1/1/1/0/0,
1/1/1/1/0, 1/1/1/0/0, 1/0/0/0/0
chemosis: 1/0/0/0/0, 1/1/0/0/0, 1/0/0/0/0,
1/1/0/0/0, 1/1/0/0/0, 1/0/0/0/0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) No. 1272/2008
- 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 polyethylenglycol 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 at the 24 h reading and in 2/6 animals at the 48 h reading. This effect was fully reversible within 72 h. Only slight other effects (iridial effects, score = 1 in 3/6 animals at the 1 h reading; Cornea score = 1 in 1/6 animals at 1 h reading; Chemosis score = 1 in 6/6 animals at the 1 h reading and in 3/6 animals at the 7 h reading) were observed after 1 and 7 h, these effects were reversible within 24 h.
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