Reaction products of diazotised 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid and 3-amino-4-hydroxy-5-nitrobenzenesulphonic acid, coupled with resorcinol, metalized with Ferric Chloride, condensed with Formaldehyde, sodium salts

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:

November 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

study performed on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 1.

Justification for type of information:

Justification for read-across is detailed at section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Royal Decree 363/1995, of 10 March

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Royal Decree 1078/93 of 2 July

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

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: authorized breeder.
- Weight at study initiation: 2001, 2453, 2607 g
- Housing: single housed in a stainless steel cage, brand Tecniplast.
- Diet: daily dose of 150 g special diet for rabbits experimental provided by an authorized provider.
- Water: filtered tap water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 25 %
- Air changes: 15 ACH with air filtered 5 µm.
- Photoperiod: 12 hour cycle dark/light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

moistened

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

24, 48, 72 hours, 7, 14 and 21 days

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 20 cm x 13 cm
- Coverage: 6 cm^2
- Type of wrap if used: Gauze type dressings (Melolin) or equivalent, Sticking plaster, hypoallergenic adhesive bandage (Fixomull Seretch) or equivalent.

REMOVAL OF TEST SUBSTANCE
- Washing: yes; after the exposure period the substance is gently removed with water or suitable solvent.

EVALUATION OF SKIN REACTIONS
Eschar formation
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Well-defined erythema....................................2
Moderate to severe erythema.........................3
Severe erythema to slight eschar formation...4

Oedema formation
No oedema..............................................................................................................0
Very slight oedema (barely perceptible).................................................................1
Slight oedema (edges well-defined)........................................................................2
Moderate oedema (raised ca. 1 mm).......................................................................3
Severe oedema (raised more than 1 mm; extending beyond area of exposure)....4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: shaved skin

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: shaved skin

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: shaved skin

Other effects:

In the three animals was observed a brown skin coloured into the application site. This effect persists after 21 days in the rabbit no. 1 and disappears after 14 days in the rabbits no. 2 and no. 3.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The substance was found to cause no irritation when applied to intact rabbit skin.

Executive summary:

The substance has been tested for skin irritation according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree1078/93.

Three male rabbits are tested with 0.5 g of test item to the shaved skin after 4 hours of patch treatment. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion.

The values of erythema and oedema, calculated as mean individual scores at 24, 48 and 72 hours, were below the trigger values for classification (2.3), therefore the substance is not classified under the CLP Regulation (EC 1272/2008).