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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:
22 Sep - 03 Oct 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

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:
-
EC Number:
400-640-4
EC Name:
-
Cas Number:
198153-89-8
Molecular formula:
C32ClH25N10Na2O9S3
IUPAC Name:
disodium 2-(4-{[4-({3-[2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]-4-sulfonatophenyl}amino)-6-chloro-1,3,5-triazin-2-yl]amino}phenyl)-6-methyl-1,3-benzothiazole-7-sulfonate
Test material form:
solid: particulate/powder
Details on test material:
Reactive Yellow 161

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 wks
- Weight at study initiation: 2000 - 2200 g
- Housing: Metal cages, housed individually
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum): ad lib.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70% rh
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
24 h prior to exposure
Vehicle:
water
Remarks:
to moisten powder
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patch, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72 h after removal

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal: 1, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
No corrosive effects observed
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not cause any significant skin irritating effects. It is not classifiable according to the CLP criteria.