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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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Remarks:
GLP was not implemented at the time of study conduct.

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
EC Number:
259-226-5
EC Name:
Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
Cas Number:
54553-91-2
Molecular formula:
C10H6O8.2C9H10N2
IUPAC Name:
benzene-1,2,4,5-tetracarboxylic acid - 2-phenyl-4,5-dihydro-1H-imidazole (1:2)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of 100% substance
Duration of treatment / exposure:
72h not rinsed
Observation period (in vivo):
6d
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.0 - 5.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Postexposure observation period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data
sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual
inspections

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
110
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.33
- Conjunctivae (Chemosis): 0
- Overall irritation score: 1.67/110
REVERSIBILITY: complete within 72 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test Item is considered not irritating based to the availabel data according to OECD405 in rabbits.

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