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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)

Deviations:

not specified

GLP compliance:

not specified

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-methylphenyl)-3-oxobutyramide]

EC Number:

226-789-3

EC Name:

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

Cas Number:

5468-75-7

Molecular formula:

C34H30Cl2N6O4

IUPAC Name:

2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2-methylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2-methylphenyl)-3-oxobutanamide

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

No rinsing of eyes in group 1 (3 animals); rinsing of eyes 30 seconds after application in group 2 (3 animals)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO (basically in accordance with OECD TG 405)

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

Remarks on result:

other: group 1 + group 2

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Remarks on result:

other: group 1 + group 2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

( no differentiation between redness and chemosis)

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Remarks on result:

other: group 1 + group 2

Irritant / corrosive response data:

No eye responses were noted in any animal at any time point.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

The test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and no eye responses were noted in any animal at any time point.

Executive summary:

The test material was tested for eye irritancy according to a procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 0.1 g neat test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, washing after 30 seconds in 3 animals, group 2) and eye responses were watched for seven days. No eye responses were noted in any animal at any time point. The test item is not irritating to eyes and has not to be classified as irritating to eyes according to the criteria of Regulation (EC) No 1272/2008.