6,15-dihydroanthrazine-5,9,14,18-tetrone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study with acceptable restrictions: - no data on purity of the test substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted may 1981)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,15-dihydroanthrazine-5,9,14,18-tetrone

EC Number:

201-375-5

EC Name:

6,15-dihydroanthrazine-5,9,14,18-tetrone

Cas Number:

81-77-6

Molecular formula:

C28H14N2O4

IUPAC Name:

6,15-dihydroanthrazine-5,9,14,18-tetrone

Details on test material:

- Purity: Lab sample
- Storage: room temperature
- Physical state: solid, insoluble in water
- Stability: guaranteed by sponsor
- Safety precautions: gloves and face masks

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Further description: KFM-NZW
- Source: Kleintierfarm, Madoerin AG, CH-4414, Fuellindorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2030 - 2120 g (within ± 20% of mean value)
- Fasting period before study: no
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland (Routine analysis of diet for nutritive contents and for contamination indicated no significant deviations expected to influence the study outcome);
- Water: ad libitum (Routine analysis for contamination indicated no significant deviations expected to influence the study outcome)
- Acclimation period: 5 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 70 mg of the test substance (corresponding to ca. 0.1 mL bulk volume)

Duration of treatment / exposure:

single application

Observation period (in vivo):

10 days.
- readings were performed at 1, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE:
- Washing: no

SCORING SYSTEM: OECD scoring method

TOOL USED TO ASSESS SCORE: Slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal # 1, 2 and 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: At the 1 hour observation, well scattered/diffuse areas of opacity (score = 2) was evident in the treated eye of animal # 1 only. The effect was fully reversible by the 24 hour observation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal # 1, 2 and 3)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Score; at 1 hour observation = 1, after 7 days = 1

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Score; at 1 hour observation = 1, after 7 days = 1

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Score at 1 hour observation = 1

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Score at 1 hour observation = 1

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Score at 1 hour observation = 1

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Score at 1 hour observation = 1

Any other information on results incl. tables

Table 1: Body weights

Animal No.	1	2	3
At start of test	2030 g	2100 g	2120 g
After 3 days	2170 g	2160 g	2200 g
After 7 days	2280 g	2300 g	2290 g
After 10 days (end)	2380 g	2370 g	2340 g

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met