GOLDEN YELLOW SCJ 1006

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study under GLP without deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: FAT 40543/A
Description: Red powder
Batch: TV RN 196-200
Purity: 90%
Test substance storage conditions: At room temperature in the dark
Stability under storage: Stable
Expiry date: November 01, 2000

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: Albino rabbit, New Zealand White (SPF-Quality), Source: Broekman Institute, Someren, The Netherlands.
Number of animals: 3 male rabbits
Age at start of treatment: Approx. 8 weeks
Body weight at start of treatment: 1412 - 1511 grams
Identification: Ear tag.
ANIMAL HUSBANDRY
Conditions: Air-conditioned room with approximately 15 air changes per hour and the environment controlled with optimal conditions considered as being a temperature of 21 °C and a relative humidity of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation: Individually in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week.
Water: Free access to tap-water diluted with decalcified water. Certificates of analysis were examined and retained in the NOTOX archives.

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

The powdery test substance was instilled as delivered by the sponsor.

Controls:

other: opposite eye served as control

Amount / concentration applied:

20.6 ±0.3 mg (0.1 mL)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

The animals were examined, and the eyes in particular, prior to test substance administration and no abnormalities were detected. On test day 1, 20.6 ±0.3 mg (0.1 ml) of the test substance was instilled in the conjunctival sac of one 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 substance. The other eye remained untreated and served as the reference control. Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
OBSERVATIONS
Mortality/Viability: Twice daily
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to instillation).
Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

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:

1.33

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritant / corrosive response data:

Instillation of approximately 20 mg (0.1 ml) of FAT40543/A into one eye of each of the rabbits resulted in effects on the conjunctivae. The irritation of the conjunctivae, consisting of redness and Chemosis of the conjunctival tissues and a small amount of discharge, had resolved within 7 days after instillation. Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
CORROSION: There was no evidence of ocular corrosion.

Other effects:

COLOURATION: Remnants of the test substance were noted in the treated eyes of all animals on day 1 and on the outside of the eyelids of one animal on day 2. Red staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.
TOXICITY SYMPTOMS / MORTALITY: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

FAT40543/A, when exposed to rabbit eyes, caused slight conjunctival effects that reversed within 7 days. However, the effects were weak and consequently th substance is not considered an eye irritant following criteria in Regulation EC No 1272/2008 (CLP).

Executive summary:

The study was carried out in accordance with the OECD guideline No. 405, 'Acute Eye Irritation/Corrosion' and the EEC Directive 92/69/EEC, B.5, 'Acute Toxicity - Eye irritation.

Single samples of approximately 20 mg of FAT40543/A (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of FAT40543/A resulted in irritation of the conjunctivae, which had resolved within 7 days in all animals. Remnants of the test substance were noted in the treated eyes of all animals on day 1 and on the outside of the eyelids of one animal on day 2. Red staining of the fur on the head and paws, caused by the test substance, was noted during the observation period. No signs of systemic intoxication were observed during the study period. FAT40543/A was considered mildly irritating (M2) to the rabbit eye (Kay and Calandra interpretation of the calculated maximum Draize score: 8 ) and consequently not subject to classification following CLP criteria.