Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

July 31, 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate

EC Number:

276-634-9

EC Name:

Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate

Cas Number:

72391-23-2

Molecular formula:

C36H36ClN3O7S.Na

IUPAC Name:

sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 21016/C
- Physical state: violet powder
- Analytical purity: 96 %
- Lot/batch No.: EN. Nr. 400047.32
- Expiration date of the lot/batch: December 1998
- Stability under test conditions: Stable at storage conditions.
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN. Nr. 400047.32
- Expiration date of the lot/batch: December 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight
- Stability of the test substance in the solvent/vehicle: Stable at storage conditions

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb:NZW(SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: ad libitum
- Water: ad libitum


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:

other: Untreated right eye served as a control

Amount / concentration applied:

TEST MATERIAL
100 mg of the test compound were instilled into the conjunctival sac of the left eye.

Observation period (in vivo):

72 hrs

Number of animals or in vitro replicates:

3 rabbits (1 male and 2 female)

Details on study design:

SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.22

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.22. Slight reddening and slight swelling of the conjunctivae, as well as slight to moderate watery discharge and hyperemia of the scleral blood vessels were observed. All findings were reversible after 48 hours. A corneal reaction consisting of damage to the superficial epithelium was seen in one unwashed eye (NC.12) at 24 hours only. Staining of the conjunctivae by the compound was noted in all unwashed eyes up to 72 hours.

Other effects:

VIABILITY/MORTALITY AND CLINICAL SIGNS: No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred
COLORATION: No staining of the cornea, sclera or conjunctivae by the test article was observed.
CORROSION: No corrosion of the cornea was observed at any of the reading times.
BODY WEIGHTS: The body weight of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

Body weights:

Animal Nr	Sex	First day of Acclimatisation	First day of treatment	Last day of Observation
19	Male	2842	3030	3102
20	Female	3035	3330	3392
21	Female	2942	3179	3259

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 21016/C is considered to be "not irritating" to the eye.

Executive summary:

FAT 21016/A was subjected to eye irritation test accrding to following guidelines: Directive 92/69 EEC, B.5 and OECD 405 guideline and in accordance to GLP. The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.22 (max. 13). Reddening and swelling of the conjunctivae as well as watery discharge and hyperemia of the scleral blood vessels were observed. However these findings were reversible after 48 hours. Cornea and iris were not affected throghout the study. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. In conclusion, FAT 21016/C is considered to be "not irritating" to the eye.