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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:
25 November 1986 to 28 November 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
EC Number:
402-170-5
EC Name:
Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
Cas Number:
106359-91-5
Molecular formula:
Hill formula: C26 H23 F N9 O13 S4 Na3
IUPAC Name:
trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
Details on test material:
- Name of test material (as cited in study report): FAT 40'224/C
- Description: powder
- Lot/batch No.: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: October 1991
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: October, 1991

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under storage conditions: Stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 13 - 14 weeks
- Weight at study initiation: 1.7 - 2.4 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D 7830 Emmendingen / FRG).
- Diet: Pelleted standard Kliba 341, Batch 21/86 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
72 h
Observation period (in vivo):
up to 72 h
Number of animals or in vitro replicates:
3 (2 males and 1 female)
Details on study design:
The eyes of the animals were observed 24 hours prior to test article administration. The test article (0.1 g per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The irritation was assessed and the corrosive properties of the test article and the color of the treated eye were described and recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Irritation: FAT 40224/C showed a primary irritation score of 0.0 when applied to the rabbit eye mucosa.
Corrosion: No corrosion of the cornea was observed at any of the measuring intervals.
Other effects:
Toxic symptoms/ mortality: No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: In the area of application a red to yellow staining of the cornea, conjunctivae, sclera and lid hairs by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Necropsy: Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40224/C was found to be not irritating or corrosive.
Executive summary:

In a GLP-compliant eye irritation study, performed according to OECD guideline 405, the test substance (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 72 hours. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. In the area of application a red to yellow staining of the cornea, conjunctivae, sclera and lid hairs by pigment or coloring of the test article was observed. The body weight gain of all rabbits was similar. Due to the results obtained, no macroscopic organ examination was indicated. The test substance showed a primary irritation score of 0.0 when applied to the rabbit eye mucosa. A red to yellow staining of the cornea, conjunctivae, sclera and lid hairs of the treated eyes by pigment or coloring of the test article was observed. Cornea, iris, conjunctivae and chemosis scores were 0.0 during the whole observation period. No corrosion was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.