Chromate(2-), [5-(diethylamino)-2-[(2-hydroxy-4-nitrophenyl)azo]phenolato(2-)][5-hydroxy-6-[(2-hydroxy-4-nitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, sodium

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 May 31 to June 03, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 284 - Similar Substance 01

IUPAC Name:

Acid Blue 284 - Similar Substance 01

Test material form:

other: solid

Details on test material:

- Commercial Name: Acid Blue 317
- EC# 271-351-7
- CAS # 68541-71-9
- Batch n. FAT-20'011/D
- Purity and composition: 52% of dye.
- IC50: >320 mg/l

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: between 2190 to 2310 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: A gauze patch (approx. 12-16 cm2) bearing 0.5 g of test substance

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 071/M, 197/M, 187/M

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

animal: 071/M, 197/M, 187/M

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No deremal effects observed

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to Regulation 1272/2008

Conclusions:

Not irritating.

Executive summary:

Method:

The Skin irritation was determined in an irritation test on rabbits according to the OECD Guideline 404 and the EU Method B.4.

Result:

Not irritating