2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

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-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]

EC Number:

226-939-8

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]

Cas Number:

5567-15-7

Molecular formula:

C36H32Cl4N6O8

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide]

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

other: English Silver

Details on test animals or tissues and environmental conditions:

TEST ANIMALS:
- Housing: individually
- Diet: NAFAG, Gossau SG, rabbit food, ad libitum
- Water: ad libitum

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 3 animals (group 1), rinsing after 30 seconds in other 3 animals (group 2)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
No rinsing of eyes in 3 animals (group 1), rinsing after 30 seconds in other 3 animals (group 2) with 10 ml lukewarm water

SCORING SYSTEM: basically in accordance with OECD TG 405

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

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:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: group 1 + group 2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 (group 1), #3, #4, #5 (group 2)

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: no differentiation between redness, chemosis, discharge

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 (group 1), #3, #4, #5 (group 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no differentiation between redness, chemosis, discharge

Irritant / corrosive response data:

No eye responses were observed except conjunctivae score 6 (incl. chemosis, discharge) in animal #3 (group 1) 24 h after application, fully reversible by 48 h after application.

Any other information on results incl. tables

	Rabbit #3 (group 1)
Days after appl.	Cornea	Iris	Conjunctivae
1	0	0	6
2	0	0	0
3	0	0	0
4	0	0	0
7	0	0	0

Conjunctivae = [Redness (max. score 3) + Chemosis (max. score 4) + Discharge (max. score 3)] x 2

The conjunctivae score for animal #3 one day after application is put together like (3 + 0 + 0) for redness score 3 or (0 + 3 + 0) for chemosis score 3 in the worst case. Discharge is not relevant for classification according to the criteria of Regulation (EC) No 1272/2008. Therefore, the maximum mean value for either conjunctival redness or chemosis over 24 h, 48 h and 72 h after application is 1, which falls below critical values for classification according to the criteria of Regulation (EC) No 1272/2008.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information 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. 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 the observed eye responses were fully reversible 48 hours after application.

Executive summary:

The test material was tested for eye irritancy according to the technique 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 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 other 3 animals, group 2) and eye responses were watched for seven days. No eye responses were observed except conjunctival score 6 (incl. redness, chemosis, discharge) in animal #3 (group 1) 24 h after application, fully reversible by 48 h 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.