Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read across substance, no information about test substance or enviromental conditions of animals, some information about animals (e.g. age, source) are missing

Justification for type of information:

Category approach as part of CSR.

Cross-reference

Reason / purpose for cross-reference:

assessment report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: see below

Principles of method if other than guideline:

The procedure adopted was the patch-test 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).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

EC Number:

235-558-6

EC Name:

Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

Cas Number:

12286-66-7

Molecular formula:

C17H16N4O7S.1/2Ca

IUPAC Name:

calcium bis[4-({1-[(2-methylphenyl)carbamoyl]-2-oxopropyl}diazenyl)-3-nitrobenzenesulfonate]

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: English Silver strain

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 2-3 kg
- Housing: singly
- Diet (e.g. ad libitum): 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):/

IN-LIFE DATES: From: To:/

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and left hand side abraded

Vehicle:

other: 50 % polyethylene glycol suspension

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% solution

VEHICLE
- PEG 400

Duration of treatment / exposure:

24h

Observation period:

72h

Number of animals:

6 (3 per sex)

Details on study design:

TEST SITE
- Area of exposure: back and flanks
- % coverage: /
- Type of wrap if used: A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- no washing

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is to be considered as non-irritant to the skin of rabbits.