Reaction products of 1,5-diaminoanthracene-9,10-dione and 1,8-diaminoanthracene-9,10-dione with bromine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer chapter 13 for detailed read across justification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,5-diaminobromo-4,8-dihydroxyanthraquinone

EC Number:

250-817-3

EC Name:

1,5-diaminobromo-4,8-dihydroxyanthraquinone

Cas Number:

31810-89-6

Molecular formula:

C14H9BrN2O4

IUPAC Name:

1,5-diamino-2-bromo-4,8-dihydroxy-9,10-anthraquinone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: FAT 36002/G TE
Lot: DX201409-01
Appearance: Dark blue powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2310 t o 2600 g
- Housing: individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C,
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

IN-LIFE DATES: From: February 10, 1987 To: February 17, 1987

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and served as a control.

Amount / concentration applied:

0.1 ml (54 mg)

Observation period (in vivo):

7 days

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40284/A can be classified as non - irritant to the eyes.

Executive summary:

An acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 40284/A on the albino rabbit eye and the associated mucous membranes. This test was based on the OECD guideline No. 405. The test was performed on 3 male rabbits. 0.1 ml (54 mg) of FAT 40284/A was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40284/A according to the OECD scoring system. FAT 40284/A induced irritation of the cornea and conjunctiva when applied into the conjunctival sac of albino rabbits. Because the mean values of the readings 24 to 72 hours after application are below the threshold of significance, FAT 40284/A can be classified as non - irritant.