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

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:

comparable to guideline study with acceptable restrictions

Remarks:

details about test substance, animal source/breeder, in life dates and animal enviroment (air changes per hour) are missing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

12 May 1981 / The study was performed before the guideline was published.

Deviations:

yes

Remarks:

exposure duration (24h instead of 6h), no washing step, no readings after 30-60 minutes and 48 hours, different scoring

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act

Version / remarks:

Sect. 191.11 (February 1965)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

276-057-2

EC Name:

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

Cas Number:

71832-85-4

Molecular formula:

C16H13ClN4O7S.1/2Ca

IUPAC Name:

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

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 3.09 kg male and 3.10 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, sterile
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and right hand site abraded

Vehicle:

other: PEG 50 % aqueous solution

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml containing 0.5 g
- Concentration (if solution): 50 %

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 ml
- Concentration (if solution): 50 %

10 g of the test compound mixed with 12 ml of a 50 % aqueous solution of polyethylene glycol to make a suspension of 20ml, 10 ml of which was applied to each test site on a 2.5 cm square gauze pad.

Duration of treatment / exposure:

24h

Observation period:

72h

Number of animals:

5 male, 1 female

Details on study design:

TEST SITE
- Area of exposure: back/flanks
- % coverage: 10
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: abraded skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: abraded skin

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: all time points

Score:

1.2

Max. score:

8

Remarks on result:

other: slightly irritating according Draize system

Irritant / corrosive response data:

24 hours:
Slight to well defined erythema was seen on all sites and very slight to slight oedema on 5/6 intact and 4/6 abraded.sites.
72 hours:
All sites were normal.

Any other information on results incl. tables

Generally, there was very little difference seen in the reactions between intact and abraded sites.

The primary irritation score was 1.2.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the test and the primary irritation score of 1.2, no indication for classification according to GHS is indicated.

Executive summary:

In the primary skin irritation test, similar to OECD 404, male and female New Zealand White rabbits were dermally treated with the test substance.

Five male and one female were singly housed and shaved (and partially abraded) before the substance was applied as a aqueous solution with polyethylene glycol as vehicle.

The test substance was covered by an occlusive coverage and the test site was treated for 24 hours.

After the removal of the coverage, the site was observed for further 72 hours.

There was very little difference seen in the reactions between intact and abraded sites and the primary irritation score was 1.2.

The test substance is not considered to be skin irritant to rabbits.