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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
Study period:
From 12 July, 1993 to 19 July, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(February, 1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(December, 1992)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-anilino-3-nitro-N-phenylbenzenesulphonamide
EC Number:
225-862-7
EC Name:
4-anilino-3-nitro-N-phenylbenzenesulphonamide
Cas Number:
5124-25-4
Molecular formula:
C18H15N3O4S
IUPAC Name:
4-anilino-3-nitro-N-phenylbenzenesulfonamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): TERASIL GELB GWL ROH FEUCHT (FAT 36014/F)
- Physical state: Yellow-brown powder
- Analytical purity: 90.7%
- Batch No.: 292347.26
- Expiration date of the lot/batch: April 01, 1998
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Bulk density: 0.87 g/mL (determined at the testing laboratory)
Specific details on test material used for the study:
Identified as: FAT 36'014/F

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approximately 12 weeks
- Weight at study initiation: 2233-2539 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least 5 d after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark.

IN-LIFE DATES: From July 12, 1993 to July 19, 1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied (weight with unit): 87±1 mg/animal
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Up to 7 d (The eyes of each animal were examined for irritation for approx. 1, 24, 48 and 72 h and 7 d after instillation of the test substance)
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Treatment of the eyes with 2 % fluorescein, 24 hours after test substance instillation

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
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
There were no signs of periocular tissue staining, body weight variability, toxicity or mortality in any animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36014/F is not irritating to the eye.
Executive summary:

A study was conducted to assess the eye irritancy potential of the FAT 36014/F (of purity 90.7 %) in New Zealand White rabbits according to OECD Guideline 405 and EU Method B.5 in compliance with GLP. A single ocular dose of 87±1 mg of test substance was applied into the lower eye lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48, and 72 h and 7 d post-instillation. Slight conjunctival irritation was observed, which resolved within 7 d of instillation. Ocular corrosion was not observed in any of the rabbits. Also, no signs of systemic intoxication were seen. Hence, it can be concluded that the test substance is not to be classified as irritating to the eye.