Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

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:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Remarks:

prior to GLP implementation

Test material

Test material information

Constituent 1

Reference substance name:

(3Z)-4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-(3-methylphenyl)diazen-1-yl]phenyl}imino)-2,3-dihydro-1H-isoindol-1-one; 4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-{4-[(4,5,6,7-tetrachloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]phenyl}amino)-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; N-{4-[(1E)-2-(2-methyl-4-{[(1Z)-4,5,6,7-tetrachloro-3-oxo-2,3-dihydro-1H-isoindol-1-ylidene]amino}phenyl)diazen-1-yl]phenyl}acetamide

EC Number:

600-734-7

Cas Number:

106276-78-2

Molecular formula:

C13H14N.C9H3Cl4NO2.CH4O.Na

IUPAC Name:

(3Z)-4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-(3-methylphenyl)diazen-1-yl]phenyl}imino)-2,3-dihydro-1H-isoindol-1-one; 4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-{4-[(4,5,6,7-tetrachloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]phenyl}amino)-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; N-{4-[(1E)-2-(2-methyl-4-{[(1Z)-4,5,6,7-tetrachloro-3-oxo-2,3-dihydro-1H-isoindol-1-ylidene]amino}phenyl)diazen-1-yl]phenyl}acetamide

Test material form:

solid: nanoform

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit food, NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped back and flank, left side also abraded, right side not abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

up to 48 hour after removal of the dressings, 72 hours after initiation of treatment

Number of animals:

6, 3 males, 3 females

Details on study design:

Two days before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on the left side was slightly scarified. For treatment gauze patches of 2.5 x 2.5 cm with test material were applied to the prepared abraded and non abraded skin, in quantities of 0,5 g.

The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure. The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment). Skin irritation was scored in accordance with the irritation score described below. The severity of skin irritation was rated as follows: A mean value of less than 2 indicated mild, from 2 to 6 moderate and above 6 severe skin irritation.

SCORING SYSTEM:
Erythema and eschar formation:
No erythema; 0
Very slight erythema (barely perceptible); 1
Well defined erythema; 2
Moderate to severe erythema; 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth); 4
Maximum possible erythema score: 4

Edema formation:
No edema; 0
Very slight edema (barely perceptible); 1
Slight edema (edges of area well defined by definite raising); 2
Moderate edema (raised approximately 1 mm); 3
Severe edema (raised more than 1 mm and extending beyond area of exposure); 4
Maximum possible edema score: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Abraded skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Abraded skin

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

8

Remarks on result:

other: No description in this study report if the test substance is moistened to ensure good skin contact.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not an irritant to the rabbit skin.

Executive summary:

A study similar to OECD Guideline 404 was performed. The primary irritation index, a measure of the acute irritation to the rabbit skin was 0. This indicates that the test material is not an irritant to the rabbit skin.