2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 24 OCT 1989 to 27 OCT 1989.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 405).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]

EC Number:

225-822-9

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]

Cas Number:

5102-83-0

Molecular formula:

C36H34Cl2N6O4

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2,4-dimethylphenyl)-3-oxobutanamide]

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: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.7 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with ca. 37 °C warm physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h.

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, 72 h.

Score:

0

Max. score:

2

Results 3

Irritation parameter:

iris score

Basis:

animal: #2, #3

Time point:

other: 24, 48, 72 h.

Score:

0.33

Max. score:

2

Reversibility:

fully reversible

Remarks:

48 h after application.

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, 72 h.

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks:

72 h after application.

Remarks on result:

other: redness

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, 72 h.

Score:

1.33

Max. score:

3

Reversibility:

fully reversible

Remarks:

72 h after application.

Remarks on result:

other: redness

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72 h.

Score:

1.67

Max. score:

3

Reversibility:

fully reversible

Remarks:

72 h after application.

Remarks on result:

other: redness

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 h.

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks:

48 h after application.

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 h.

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Remarks:

72 h after application.

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 h.

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks:

72 h after application.

Irritant / corrosive response data:

No corneal opacity was observed during the study. Iris score 1 was observed in 2/3 animals 24 h after application. No other iridial responses were observed. Conjunctival redness was observed in every animal one, 24 and 48 h after application (max. score 3). Chemosis was observed in every animal one and 24 h after application and in 2/3 animals 48 h after aplication. No effects were noted 72 h after application.

Other effects:

Transparent discharge, yellow coloured from test substance, was observed in every animal one hour after application and in one animal 24 h after application.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: other: CLP regulation

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material Permanent-Gelb P-GRL neu contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.

Executive summary:

The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal effects were observed. Iridial responses were observed 24 h after application, fully reversible by 48 h after application. Conjunctival redness and Chemosis were observed in 3/3 animals up to 48 hours after application, fully reversible by 72 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.