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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
october 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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)
Deviations:
yes
Remarks:
7 days post observation period only
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(2+) bis(5-chloro-2-[(1E)-2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]-4-methylbenzene-1-sulfonate)
Test material form:
solid: nanoform
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

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:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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:
GHS criteria not met