Dibromopyranthrene-8,16-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

BASF internal testing method

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Vat Orange 002 - Similar Substance 01

IUPAC Name:

Vat Orange 002 - Similar Substance 01

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Talcum

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

no data

Details on study design:

Animals were observed after 1, 24 hours and 8 days.

SCORING SYSTEM:
Erythema and Edema
Ø - no effect
(+) - questionable
+ - mild
++ - moderate
+++ - marked

R - erythema
Ö - edema
Sch - desquamation
N - necrosis
Tr - opacity
Na - scar

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 8 d

Max. score:

3

Reversibility:

other: inconclusive

Remarks on result:

other: inconclusive

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Within the first hour, slight redness occurred and lasted until day 8. Since the observation period stopped at day 8, no conclusion can be done on the reversibility. No signs of corrosion observed.

The positive control (Talcum) caused slight irritation after 24 h which was fully reversible within 8 days.

Any other information on results incl. tables

Table 1: Results on Eye Irritation

	Findings after
	1 hour	24 hours	8 days
Test item	R+/Ö+/black substance residues	R+	R+
Talcum	R+/Ö+	R+	Ø

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The substance caused slight redness in rabbit eyes. However, the observation period stopped at day 8, no conclusion can be done on reversibility and severity of the redness. Therefore, the study is not used for classification purposes.

Executive summary:

The substance caused slight redness in rabbit eyes. However, the observation period stopped at day 8, no conclusion can be done on reversibility and severity of the redness. Therefore, the study is not used for classification purposes.