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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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:
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: all time points
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
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

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