Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

according to OECD and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EEC

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

EC Number:

225-935-3

EC Name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

Cas Number:

5160-02-1

Molecular formula:

C17H13ClN2O4S.1/2Ba

IUPAC Name:

barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Animal specifics: New Zealand White , conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (fully air-conditioned)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 mL to moisten the test item
- Lot/batch no. (if required): polyethylene glycol 400, Ch-B 2322 , Riedel de Haen AG

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
approximately 24 h before treatment the test site was clipped free of hair (25 cm2).
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG), fixed with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
as in EU Method B.4, assessed approximately 30 - 60 min, 24, 48, and 72 h after the removal of the test item

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3 each

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0

Max. score:

4

Reversibility:

other: Animal 1: Erythema grade 1 observed at 30-60 min reading was fully reversible within 24 hours. Animal 2 & 3: Reversibility not relevant since no effects occured.

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3 each

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects occured

Irritant / corrosive response data:

Scores (oedema or erythema) were 0 at 24, 48 and 72 h after removal of dressing in all animals

Other effects:

light-red staining produced by the color of the test item was present in all animals at all reading time points.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.

The application of the test item to the skin resulted in slight, early-onset and transient erythema in one animal. This effect was reversible and no longer evident 24 hours after treatment. Light-red staining of the treated skin (caused by the color of the test item) was noted in all animals throughout the whole study. Mean scores of all animals for edema and erythema were 0. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.

Therefore, the test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008.