REAKTIV OLIV F00-149

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-01-14 to 2002-03-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, only one animal tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-640-7

EC Name:

-

Cas Number:

479541-17-8

Molecular formula:

Hill formula: C32H26CuFN9Na4O19S5

IUPAC Name:

Tetrasodium 2-(4-fluoro-6-(2-(2-sulfonatoethansulfonyl)ethyl amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(2-(2-hydroxy-5- sulfonatophenylazo)-4,5-dimethoxyphenylazo)-7-sulfonatonaphthalene-1-sulfonatocuprate(II)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Oliv F00-0149

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 3.4 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24h

Observation period (in vivo):

1, 24, 48 and 72 hours after administration of the test substance

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after administration the treated eye was washed out thoroughly with isotonic saline at approx. 37 °C. The eye was also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

SCORING SYSTEM:
-Cornea: opacity (0-4), affected area (0-4)
-Iris (0-2)
-Conjunctivae: redness (0-3,9), chemosis (0-4), discharge (0-3)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

<= 0.67

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Max. score:

2

Remarks on result:

other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

<= 0.33

Results 4

Irritation parameter:

chemosis score

Max. score:

2

Remarks on result:

other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

<= 0

Results 6

Irritation parameter:

cornea opacity score

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

<= 0

Results 8

Irritation parameter:

iris score

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes not fully reversible within 21 days

Any other information on results incl. tables

1 hour after the 72-hour injection a light redding of the conjunctiva was observed. 1 hour after the 24-hour injection

a light swelling occured. Clear green outflow. 2 days pa all signs of the swelling were disappeared.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information discolouration of the eye is considered a dye specific effect Criteria used for interpretation of results: expert judgment

Conclusions:

The applicant concluded that the persistent discolouration of the eye is a dye specific effect and does not require classification.

Executive summary:

In a primary eye irritation study, 100 mg of Reactive Olive F00 -0149 was instilled into the conjunctival sac of the left eye of 1 New Zealand White rabbit for 24 hours. The treated eye was washed out thoroughly with isotonic saline at approx. 37 °C after 24 hours. Additionally, the eye was washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed. The animal was then observed for 3 days. Irritation was scored by the method described by Draize.

From one hour up to one day after application the conjunctiva of the animal showed injected blood vessels up to a diffuse crimson red color and swelling with partial eversion of the lid. Additionally, there was presence of a clear substance colored (green) eye discharge. 2 days after application the irritations had disappeared. Nictitating membrane and conjunctiva were green discolored from day 2 up to the end of the study. Redness and chemois of the conjunctiva received a score of 0.67 and 0.33, respectively, while the corneal opacity and iris scores were 0.

In this study, Reactive Olive F00-0149 would be an eye irritant based on persistent discoloration. However, the applicant concluded that the persistent discolouration of the eye is a dye specific effect and does not require classification.