Trisodium bis[3-[[1-(anilinocarbonyl)-2-oxopropyl]azo]-5-chloro-2-hydroxybenzenesulphonato(3-)]cobaltate(3-)

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:

From December 17 to January 9, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 204 - Similar Substance 01

IUPAC Name:

Acid Yellow 204 - Similar Substance 01

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: IVANOVAS
- Age at study initiation: 2-3 kg
- Weight at study initiation:
- Housing: metal cage
- Diet: standard rabbit food - NAFAG ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod : 10 hours light cycle dark/light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

other: propylene glycol + saline (70 : 30 parts)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g of the test material
- Concentration: 50 %

Duration of treatment / exposure:

24 hour

Observation period:

7 days

Number of animals:

3 male and 3 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 164, 169

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal: 165, 166, 167, 168

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No signs of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal: 164, 169

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal: 165, 166, 167, 168

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No signs of irritation

Any other information on results incl. tables

Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Evaluation of the skin reactions

TIME		After 24 h						After 49 h						After 72 h
SEX		MALE			FEMALE			MALE			FEMALE			MALE			FEMALE
Animal N°		164	165	166	167	168	169	164	165	166	167	168	169	164	165	166	167	168	169
Erythema	a	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Edema	a	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Total	a	2	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mean	a	0.6			0.6			0			0			0			0
	b	0			0			0			0			0			0
Group mean	a	0.6						0						0
	b	0						0						0
TIME		After 4 days						After 7 days
SEX		MALE			FEMALE			MALE			FEMALE
Animal N°		164	165	166	167	168	169	164	165	166	167	168	169
Erythema	a	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0
Edema	a	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0
Total	a	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0
Mean	a	0			0			0			0
	b	0			0			0			0
Group mean	a	0						0
	b	0						0

mean reaction score
time after exposure	erythema		edema
	intact skin	abraded skin	intact skin	abraded skin
24	0.3	0	0.3	0
72	0	0	0	0
total	0.3	0	0.3	0	0.6

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Non irritant

Executive summary:

The substance has been tested According to EPA OPP 81 -5 guideline. Under the conditions of the present experiment the test item was found to cause no irritation when applied to intact and abraded rabbit skin according to the Regulation EC n. 1272/2008.