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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

october 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, GLP conform, according then in force OECD guideline (7 days post observation period only), acclimatization period not mentioned, in life data not given, rationale for vehicle (undiluted PEG 400) not given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

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

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:

TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ·C
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: PEG 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): pasted with 0.9 ml polyethylene glycol 400

VEHICLE (PEG 400, Riedel-de Häen Ag, Seelze)
- Amount(s) applied (volume or weight with unit): about 1 ml

Duration of treatment / exposure:

4h

Observation period:

30 - 60 minutes, and 24, 48 and 72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal region
- % coverage: 25 cm2
- Type of wrap if used: surgical plaster and semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4h, with luke warm water

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: all time points

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: all time p oints

Score:

0

Max. score:

4

Irritant / corrosive response data:

Three days after the application 2 animals showed very slight up to well-defined erythema. The skin surfaces were slightly discolourered, and dry-rough and fine up to coarse scales were noted. Seven days after the application all signs of irritation were reversible.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU