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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:
15 - 22 Nov 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
EC Number:
281-589-3
EC Name:
5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
Cas Number:
83969-12-4
Molecular formula:
C17H27N6S.CH3O4S
IUPAC Name:
4-{2-[(2E)-5-[bis(propan-2-yl)amino]-3-methyl-2,3-dihydro-1,3,4-thiadiazol-2-ylidene]hydrazin-1-ylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium methyl sulfate
Test material form:
liquid
Details on test material:
Basic Blue 159 methyl sulfate

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: one animal/cage (type III)
- Diet (e.g. ad libitum): "ssniff K4", ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl
Duration of treatment / exposure:
4h exposure
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed patch (hypoallergenic)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4h after exposure

OBSERVATION TIME POINTS
1h, 24h, 48h, 72h, 7d and 14d

SCORING SYSTEM:
- Method of calculation: Draize

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
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

irritation scores

animal nr    observation time
24h 48h 72h
I erythema 0 0 0
edema 0 0 0
II erythema 0 0 0
edema 0 0 0
III erythema 0 0 0
edema 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not cause any signs of irritation on rabbit skin. The substance is not classifiable according to CLP criteria.