Reaction mass of Chromate(1-), [N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-, hydrogen, compd. with N-cyclohexylcyclohexanamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1) and hydrogen bis[N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

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

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

12237-23-9

Specific details on test material used for the study:

- Name of test material (as used in study report): TK-10358

Test animals

Species:

rabbit

Strain:

other: English Silver

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: separately in V2A wire cages,
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: 50% polyethylene glycol suspension (PEG 400)

Controls:

not specified

Amount / concentration applied:

0.5 g at each side

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6 (3 males / 3 females)

Details on study design:

TEST SITE
- Area of exposure: whole back using a gauze patch 2.5 x 2.5 cm soaked with the test item
- Type of wrap if used: 5 x 5 cm plastic film

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24 h and 72 h

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
Total 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
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

24 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: all

Time point:

24 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal: all

Time point:

72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24/72h

Score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met