4,10-dibromodibenzo[def,mno]chrysene-6,12-dione

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:

comparable to guideline study with acceptable restrictions

Remarks:

Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.42

GLP compliance:

no

Remarks:

pre-guideline study

Test material

Test material information

Constituent 1

Reference substance name:

4,10-dibromodibenzo[def,mno]chrysene-6,12-dione

EC Number:

224-481-3

EC Name:

4,10-dibromodibenzo[def,mno]chrysene-6,12-dione

Cas Number:

4378-61-4

Molecular formula:

C22H8Br2O2

IUPAC Name:

4,10-dibromonaphtho[7,8,1,2,3-nopqr]tetraphene-6,12-dione

Test material form:

solid: nanoform

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: J. Scheele, Büderich, Germany
- Housing: single caged
- Diet: standard diet Ssniff K 4

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one eye, remaining untreated, serves as a control

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

24 h (rinsing not explicitelx specified in the report)

Observation period (in vivo):

examinations at 24, 48, 72 h , and 7 days after instillation

Number of animals or in vitro replicates:

6

Details on study design:

100 mg of the test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control.The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours and 7 days. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. Any or all eyes may be washed with sodium chloride solution after the 24-hour reading.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 1-6 each

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (cornea) at any time

Results 2

Irritation parameter:

iris score

Basis:

animal: # 1-6 each

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no signs of irritation (iris) at any time

Results 3

Irritation parameter:

chemosis score

Basis:

animal: # 1-6 each

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (chemosis) at any time

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: # 1-6 each

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no signs of irritation (conjunctivae) at any time

Irritant / corrosive response data:

No ocular reactions were observed in any animal at any time.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) 1272/2008

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.

Executive summary:

The test material was subject to an acute eye irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. 100 mg test substance were placed into the conjunctival sac of one eye of each rabbit. Reactions were recorded frequently during the observation period of 7 days. No effects were observed for all irritation parameter during the study. Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.