2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-nitrobenzenamine and resorcinol, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

march 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not GLP compliant but good described study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: REAL DECRETO 363/1995, 10 march

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 75

IUPAC Name:

Acid Brown 75

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: authorized supplier.
- Weight at study initiation: 2033-2113 g
- Housing: Stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water: filtered tap water (5 µm) , ad libitum
- Acclimation period: 7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity (%): 55 ± 25%
- Air changes (per hr): 15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied:0.5 g

Duration of treatment / exposure:

4 hours of treatment

Observation period:

1, 24, 48 ,72 hours and 7+14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure:dorsal-column area near the spine, forming a rectangle 20 cm x 13 cm .
- % coverage: 6 cm^2
- Type of wrap if used: simple bandage and covered in turn with a light hypoallergenic adhesive bandage .

REMOVAL OF TEST SUBSTANCE
- Washing : yes

SCORING SYSTEM: erithema and edema (similar to OECD 404)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for skin irritation following OECD 404.Under the experimental conditions the substance did not show any irritation properties.

Executive summary:

The substance was tested for skin irritation following OECD 404 . Three New Zealand white rabbits were tested with an occlusive method. After 14 days of observation no rabbit shows signs of erythema or edema. The substance is classified as non-irritating to the skin.