Trisodium 2,4-diamino-3,5-bis-[4-(2-sulfonatoethoxy)sulfonyl)phenylazo]benzenesulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec. 11, 1996 to Jan. 28, 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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

German GLP

Test material

Test material information

Constituent 1

Reference substance name:

FAT45'176/A

IUPAC Name:

FAT45'176/A

Test material form:

other: solid

Details on test material:

Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown solid
Storage: room temperature
Expiration date: 11/2004

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: WP2/96
- Expiration date of the lot/batch: November 30, 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20°C) away from light
- Stability under test conditions: stable at storage conditions

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

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
- Weight at study initiation: 3.1 kg; females: 3.0 - 3.2 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: Pelleted standard Kuba 341 rabbit maintenance diet (batch 71/96) ad libitum from Kuba Mühlen AG, CH-4303 Kaiseraugst
- Water: Community tap water from Itingen, ad libitum
- Acclimation period:

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

IN-LIFE DATES: December 16 - 30, 1996

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

one second

Observation period (in vivo):

14 days.

Viability/Mortality: Daily
Clinical Signs: Daily during the observation period.
Body Weights: At the start of acclimatization, on the day of treatment and at termination of observation.
Irritation Scores: The eyes of each animal were examined for ocular irritation approximately 1, 24, 48 and 72 hours, as well as 7 and 14 days after administration.

Number of animals or in vitro replicates:

one male, two females

Details on study design:

The eyes of the animals were examined for intactness once, one day prior to test article administration. Only those animals with no signs of ocular injury or irritation were used on the test.
At treatment, 0.1 g of the test article (undiluted) 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.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission Washington, D.C, 20207 was used for additional control purposes (Washington, 1977).

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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:

FAT 45'176/A showed a primary irritation score of 0.00 when applied to the conjunctival sac of the rabbit eye.
No corrosion of the cornea was observed at any of the reading times.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Short- to middle-term light orange staining of the cornea, conjunctivae and sclera were noted in all animals. Staining was reversible by day 14.
The body weight of the animals was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT45'176/A was not irritating to the rabbit eye.

Executive summary:

An eye irritation study was performed to assess the possible irritation potential when single doses of FAT 45'176/A were placed in the conjunctival sac of rabbit eyes. The study was carried out according to OECD 405 and EU B.5 guideline.

Test carried out by instillation of 0.1 g into one eye of each of three young adult rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately1, 24, 48 and 72 h as well as 7 and 14 days after test article application.

The test article FAT 45,176/A caused short-term swelling of the conjunctivae in one rabbit and increased lacrimation in all rabbits after one hour only. The test article caused light orange staining of various ocular structures and was reversible after two weeks.

The scores of each animal at the following reading times (24, 48 and 72 h) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 h and then dividing the resulting total by the number of figures. The primary irritation score was 0.00 (Cornea opacity, Iris, Redness and Chemosis score was ‘0’).

Based on the study results, FAT45'176/A was considered non irritating to the rabbit eye.