JAUNE REACTIF 181

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 April 1990 to 20 April 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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)

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): FAT 40'400/A
- Lot/batch No.: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
- Stability: Stable

Specific details on test material used for the study:

Identification Code: FAT 40400/A
Batch No.: BG 3247/TV6
Expiration date: 03/95
Stability of test article in vehicle: stable for at least 2 hours
Stability: Stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: Males: 15 weeks, Females: 16 weeks
- Weight at study initiation: Males: 2.7 kg, Females: 2.5-2.7 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet: Pelleted standard Kliba 341, batch 52/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen ad libitum
- Acclimation period: Four days under test conditions after veterinary examination

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:

no

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

24, 48 and 72 h

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

The eyes of the animals were observed one day prior to test article administration. The test article (0.1 g) 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. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The irritation was assessed and the corrosive properties of the test article and the staining of the treated eye were described and recorded.

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

Results 5

Irritation parameter:

other: Primary Irritation Score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation: FAT 40400/A showed a primary irritation score of: 0.0 when applied to the conjunctival sac of the rabbit eye.
Corrosion: No corrosion of the cornea was observed at any of the measuring intervals.

Other effects:

Toxic symptoms/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: Yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all treated animals throughout the 72-hours observation period.
Body weights: The body weight gain of all rabbits was similar.
No necropsy was performed. All animals were killed and discarded.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40400/A was found to be not irritating or corrosive to rabbit eyes.

Executive summary:

In a GLP-compliant eye irritation study, performed according to OECD guideline 405 and EU method B.5, FAT 40400/A (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 72 h. No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. There were yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all treated animals throughout the 72-hour observation period. The body weight gain of all rabbits was similar. There was no necropsy was performed. All animals were killed and discarded.

The test substance showed a mean chemosis, cornea, iris, and conjunctivae scores of 0.0 during the whole observation period. The primary irritation score (24, 48 and 72 h) was 0.0. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive to rabbit eyes.