Reaction mass of Sodium, bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]chromate(1-) and sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1Hpyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

October 03, 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

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:

Acid Orange 074 - Similar Substance 01

IUPAC Name:

Acid Orange 074 - Similar Substance 01

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 1.5 to 2 kgs
- Housing: separately in V2A wire cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 h

Observation period:

72 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure:
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: plastic film 5 x 5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24 hours

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

SCORING SYSTEM:
- Method of calculation:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3, 5, 6

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

other: no symptomes observed

Results 2

Irritation parameter:

erythema score

Basis:

animal: 4

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

edema score

Basis:

animal: 1, 3, 5, 6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no symptomes observed

Results 4

Irritation parameter:

edema score

Basis:

animal: 2, 4

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

Method

The skin irritation potential of the test substance was evaluated in six rabbits (3 males and 3 females) according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)".

Results

Not skin irritant