Alkali salt of (sulfonato oxyethane sulfonyl) arylamino triazinylamino sulfonato (sulfonato arylazo) aryl sulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 07, 2006 to July 10, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Rot F99-0078

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ferenc Sandor breeder, 2173 Kartal, Csaszar ut 135, Hungary
- Date of receipt: June 27, 2006
- Age at study initiation: 10 weeks old, adult albino rabbit
- Body weight range at treatment: 2,706-2,838 g (i.e., at the beginning of the study), 2,746-2,908 g (i.e., at the end of the study)
- Sex: Male.
- Housing: Animals were housed individually in metal cages
- Diet: Purina Base – Lap gr. diet for rabbit produced by Agribrands Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: Tap water from automatic self-supplying watering system, ad libitum
- Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined 24 h prior to the start of study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
- Acclimation period: 10 d
- Animal identification: The individual identification was performed by numbered ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: July 07, 2006 to July 10, 2006

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 h following administration of the test substance.

Number of animals or in vitro replicates:

3 males

Details on study design:

Test Procedure
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition, any with ocular lesions were rejected.
In the first step an initial test was performed using one animal. The test substance was instilled into the conjunctival sac of the left eye. The eyelids were held closed gently for several seconds to prevent the loss of the test substance. The contralateral eye served as control. Immediately after the administration of the test substance, an assessment of the initial pain reaction was made.

After consideration of the ocular responses produced in the first animal, two additional animals were treated. Before the administration the treated eyes of animals were not anaesthetised, because the score of initial pain reaction in the first animal indicated practically no initial pain.

Duration of Exposure
The eyes of the test animals were not washed out after the application of test substance.

OBSERVATIONS AND SCORING

Clinical Observations
The eyes were examined at 1, 24, 48 and 72 h after the treatment. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill-health during the study were recorded. At the end of the observation period all animals were sacrificed by intramuscular injections of Ketamin and Xylazin followed by i.v. Euthanyl anaesthesia.

Scoring and Assessment of Local Reaction
The eye irritation scores were evaluated according to the scoring system by Draize (1959) and OECD 405 (24 April 2002).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

- 1h after treatment in all animals the vessels were more diffuse, with obvious conjunctival swelling with partial eversion of the lids and the discharge with moistening of the lids and hairs on considerable area around the eye was found.
- Corneal and iris alterations were not recorded throughout the study period.
- 24 h after treatment in all animals displayed some hyperaemic blood vessels. In two animals the discharge from the eye was greater than normal. In one animal some swelling above normal was observed at this time.
- 48 h after treatment every animal was symptom-free.
- 72 h after treatment the study was terminated, since no primary irritation symptoms occurred.
- During the study the control eyes of animals were symptom-free.

Other effects:

- General state and the behaviour of animals were normal throughout the study period.
- There were no notable body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance was not considered to be irritating to eyes.

Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in male New Zealand White rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.

A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were not washed out after admnistration. The untreated eyes served in each case as a control.

Moderate redness, chemosis and severely increased discharge were observed 1 h after the single application. All animals were free of irritation symptoms after 48 h. Further, no corneal and iris alterations were observed throughout the study period. In addition, no clinical signs of systemic toxicity and no notable body weight changes were seen during the study period.

Under the test conditions, the test substance was not considered to be irritating to eyes.