6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one

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: Test performed before OECD and GLP guideline implementation. Important aspects (dosing, exposure duration, reading time points, grading criteria) comparable with current OECD guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register Vol 38, no 187, S. 27019, 1973

Deviations:

no

GLP compliance:

no

Remarks:

pre-guideline study

Test material

Test material information

Constituent 1

Reference substance name:

6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one

EC Number:

219-163-6

EC Name:

6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one

Cas Number:

2379-74-0

Molecular formula:

C18H10Cl2O2S2

IUPAC Name:

6-chloro-2-[(2E)-6-chloro-4-methyl-3-oxo-2,3-dihydro-1-benzothiophen-2-ylidene]-4-methyl-2,3-dihydro-1-benzothiophen-3-one

Test material form:

solid: nanoform

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 1,5 - 2,0 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 ad libitum
- Water: tap water ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye remained untreated and served as control respectively

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h, rinsing with physiol. saline 24 h after instillation

Observation period (in vivo):

examinations at 1, 7, 24, 48, 72 h after instillation

Number of animals or in vitro replicates:

6

Details on study design:

Application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively

- Instillation: 100 mg of the undiluted substance

- Washing: Washing with physiological saline 24 h after administration

- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium, under UV light

The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 38 - 43 each

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: # 38 - 43 each

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: # 38 - 41 each

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: # 42, 43 each

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal: # 38 - 43 each

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

discharge was observed in 3 animals 1 h after instillation, which was noted in 1 animal up to 24 h. Discharge was no longer evident at later time points in any animal.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

regulation (EC) 12727/2008

Conclusions:

Very slight reactions (conjunctiva redness) were observed in 2 of 6 animals 24 h after instillation, which were fully reversible within 48 h. Therefore the test item has not to be classified for eye irritation according to the criteria of Regulation (EC) No 1272/2008.

Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of the test substance were applied to one eye of six animals respectively. The eyes were washed 24 h after instillation and eye responses were noted for 72 h after start of the exposure. Slight initial signs of irritation (conjunctiva redness, chemosis and discharge) were observed at the 1 h and 7 h readings, which were stil evident in 2 animals after 24 h (conjunctiva redness). All signs of irritation were fully reversible within 48 h. No effects on cornea and iris were observed at any reading time point.

Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.