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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 - 27 Nov 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
EC Number:
240-267-2
EC Name:
Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
Cas Number:
16102-99-1
Molecular formula:
C22H18N2O11S3.2Na C22H16N2Na2O11S3
IUPAC Name:
disodium 1-amino-9,10-dioxo-4-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Albino New Zealand Rabbit
Source: Hoechst AG
Food: Altromin 2123 for rabbits
Water: deionised and chlorinated water
Food and water ad libitum
Single housing
Weight: 2.3 to 2.7 kg
Age: ca. 3 - 5 months
Temperatur: 20°C
Relative air humidity: 50%
Light: 12/12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg (pasting with 0.3 mL physiological saline) on 2.5 cm x 2.5 cm cellulose patches
Duration of treatment / exposure:
4 h
Observation period:
30 min, 60 min, 24 h, 48 h, 72 h after exposure end
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure shaved skin: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 x 2.5 cm cellulose patch, semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours, washed with tepid water

SCORING SYSTEM: OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no irritation
Remarks on result:
no indication of irritation
Other effects:
Up to 60 min after exposure, 3 / 3 animals showed large-scale discolouration (blue). After 24 h, still 2 / 3 animals showed the discolouration (blue).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No irritating effect on rabbit skin was observed after 24/48/72 h (erythema/edema score). The test item does not meet the classification criteria according to the CLP Regulation.