Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From the 26th of November, to the 7th of December, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Test conducted according to internationally accepted testing guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)

EC Number:

277-554-7

EC Name:

Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)

Cas Number:

73612-40-5

Molecular formula:

C32H24Cl2CoN10NaO8S2

IUPAC Name:

sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)

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
Breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
Age: 12-14 weeks old
Weight at study initiation: 2330 to 2680 g. The body weight was recorded at start and on day 3 and 7of the test.
Housing: metal cages, individually numbered ear tags
Diet: rat food -NAFAG 814, Gossau SG, ad libitum
Water: ad libitum. The quality of the drinking water was according to the specification "Schweizerisches Lebensmittelbuch" (Edition 1972)
All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results available.
Acclimatization: 5 days

ENVIRONMENTAL CONDITIONS
Temperature: 20°C (+/- 3°)
Humidity: 30-70 %
Photoperiod (hrs dark / hrs light): 12 hours light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g of the test substance

Duration of treatment / exposure:

72 hours

Observation period:

The animals were checked d aily for systemic symptoms and mortality.
1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Number of animals:

3 rabbits (3 females)

Details on study design:

PREPARATION OF THE SKIN
An area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
A gauze patch 12-16 cm2 bearing 0.5 g of the test substance was applied to the flank. The skin area exposed directly to the test article was approx. 6 cm2.
A control gauze patch was applied to the contralateral flank. Both gauze pa tches were moistened before application with distilled water.
COVER
The patches were loosely covered with an aluminum foil (36 cm2) and held in place for 4 hours by an adhesive tape (Isoplast , Isoplast AG CH-5200 Brugg).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Because reactions were observed within 72 hours after removing the bandages, the observation period was extended to 7 days to determine the reversibility of the skin reactions. The skin reactions observed were reversible until the end of the observation period on day 7.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

Not irritating

Executive summary:

The test was carried out according to the OECD401 Guideline, in GLP.

Under the experimental conditions employed the substance induced erythema end edema reactions when applied to the clipped albino rabbit skin. The mean values of the recordings from 24 to 72 hours after application are:

Erithema (mean 24, 48, 72 hours):

animal 1: 0.67

animal 2: 1.0

animal 3: 1.0

Edema (mean 24, 48, 72 hours):

animal 1: 0.0

animal 2: 0.33

animal 3: 0.33