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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
Study period:
May 18 to May 25, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenyl-1H-benzimidazole-5-sulphonic acid
EC Number:
248-502-0
EC Name:
2-phenyl-1H-benzimidazole-5-sulphonic acid
Cas Number:
27503-81-7
Molecular formula:
C13H10N2O3S
IUPAC Name:
2-phenyl-1H-benzimidazole-5-sulphonic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.69 (:,43 - 2.91) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm^2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24 °C
- Humidity (%): 44 to 67 %

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 ml Test item liquid (containing 40 % Eusolex 232 in water)
Duration of treatment / exposure:
1 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (2m, 1f)
Details on study design:
To ensure that only rabbits without ocular abnormalities were included in the study, 24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope after Eisenhut (Basel).

SCORING SYSTEM: DRAIZE, J.H.: "Dermal toxicity", In.: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Association of Food and Drug Officials of the USA (eds.), Baltimore (1959)

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 and CLP.
Executive summary:

The primary eye irritation potential of Phenylbenzimidazole sulfonic acid was tested in 3 New Zealand White rabbits according to test guideline OECD 405. Aliquots of 0.1 mL of a liquid formulation consisting of 40 % active substance was instilled into the conjunctival sac of the left eye of each of 3 rabbits. The right eyes remained untreated and served as controls. The rabbits were investigated for eye irritation 1 hour after treatment and then daily for a period of 8 days. Effects on the cornea, iris and conjunctivae were evaluated according to the Draize scale (1959). After single instillation of 0.1 mL of a formulation consisting of 40 % Phenylbenzimidazole sulfonic acid into the conjunctival sac of the left eye, without rinsing, a very slight irritation (slight reddening) of the conjunctivae was observed in one rabbit only on day 1 of the study. Afterwards no irritation could be detected. No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 and CLP.