3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]

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:

comparable to guideline study with acceptable restrictions

Remarks:

(mostly due to limited documentation before GLP (no data on test substance purity); Draize test; deviation: washing conducted at 3 of 6 animals).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

(washing conducted at 3 of 6 animals)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]

EC Number:

226-970-7

EC Name:

3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]

Cas Number:

5580-57-4

Molecular formula:

C43H35Cl5N8O6

IUPAC Name:

3,3'-{(2-chloro-5-methyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis[4-chloro-N-(3-chloro-2-methylphenyl)benzamide]

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- source: no data
- Weight at study initiation: 1.4 to 1.8 kg
- Housing: individually
- Diet: standard diet of Nafag ad libitum
- Water: drinking water ad libitum
- Acclimation period: yes, unspecified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1 min (3 animals were rinsed after application with physiologic saline); for the other three animals: see observation period, no rinsing conducted

Observation period (in vivo):

observation after 1 and 6h, 1, 2, 3, 6 and 8 days

Number of animals or in vitro replicates:

6 rabbits (3 male and 3 female animals)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of 3 animals were rinsed after application with physiologic saline.
- Time after start of exposure: 1 minute

SCORING SYSTEM: according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO (Draize)

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal 1-6; with and without washing)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal 1-6; with and without washing)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal 1-6; with and without washing)

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Conjunctivae redness (score 1-2) at all animals 1 h after administration; reversible in 3 animals (with and without washing) 6 h after application; the other 3 animals recovered within 24 h after administration

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal 1-6; with and without washing)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 6 h

Remarks on result:

other: Chemosis in 1 animal (with washing) 1 h after administration; reversible within 6 h

Irritant / corrosive response data:

The preparation was found to cause minimal conjunctival irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of little but assessable effect.
Discharge (Score 1) was observed in 5 of 6 animals (with and without washing) 1 h after administration.
All findings were negative after 24 hours.

Any other information on results incl. tables

Primary irritation score in unrinsed eyes: 0.4

Primary irritation score in rinsed eyes: 0.2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment preparation the test substance was found to cause minimal irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of little but assessable effect. No classification according to CLP requirements is necessary.