Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 October 1995 to 06 November 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

EC Number:

274-395-5

EC Name:

Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

Cas Number:

70209-97-1

Molecular formula:

C25H22ClN5O7S2.Na

IUPAC Name:

sodium 2-({2-amino-8-hydroxy-6-[(2-methylphenyl)sulfamoyl]-1-naphthyl}diazenyl)-5-[(chloroacetyl)amino]benzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
1.56
- Expiration date of the lot/batch:
June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In refrigerator (ca. 4 °C) protected from sunlight
- Stability under storage 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: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
- Age at study initiation: 13 weeks
- Weight at study initiation: male : 2.2 kg; females: 2.2 - 2.3 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 Kliba 341, Batch no. 91/95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark

IN-LIFE DATES: From: October 25, 1995 To: December 12, 1995

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

1 male and 2 females

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

24 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

48 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0.77

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

No corrosion of the cornea was observed at any of the reading times.

Other effects:

- Swelling of the conjunctivae was reversible after seven days.
- Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.
- Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.

Any other information on results incl. tables

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.

 

IRRITATION

FAT 20'075/B showed a primary irritation score of: 1.11, when applied to the conjunctival sac of the rabbit eye. Slight-to-moderate swelling of the conjunctivae was noted in all animals but was reversible after seven days. Slight-to-moderate watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.

 

COLORATION

Light red or red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.

 

CORROSION

No corrosion of the cornea was observed at any of the reading times.

 

BODY WEIGHTS

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:

FAT 20075/B is classified as "not irritating" to the rabbit eye.

Executive summary:

Primary eye irritation study in rabbits with FAT 20075/B was conducted according to OECD 405 guideline and in accordance with GLP in 1995. 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 (1 male and 2 female) 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 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. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of the animals was within the normal range of variability. It was found to be 1.11, when applied to the conjunctival sac of the rabbit eye. Swelling of the conjunctivae was reversible after seven days. Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days. Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. No corrosion was observed at any of the measuring intervals. Based on the study results FAT 20075/B is classified as "not irritating" to the rabbit eye.