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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study conducted prior to GLP

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)
Version / remarks:
Juli 1983
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
m-(4,5-dihydro-5-imino-3-methyl-1H-pyrazol-1-yl)benzenesulphonic acid
EC Number:
268-387-0
EC Name:
m-(4,5-dihydro-5-imino-3-methyl-1H-pyrazol-1-yl)benzenesulphonic acid
Cas Number:
68083-38-5
Molecular formula:
C10H11N3O3S
IUPAC Name:
3-(5-imino-3-methyl-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill, Ltd., Huntingdon, England
- Weight at study initiation: ca. 3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Ssniff K Pellets, ad libitum
- Water (e.g. ad libitum): drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12h / 12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
area of 6x6 cm
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
4h
Observation period:
7d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: gauze pad occluded with elastic, adhesive dressing

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

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

SCORING SYSTEM:
- Method of calculation: Draize-grading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h-7d
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h-7d
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Test item is not irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study was conducted according to OECD guideline 404 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the skin irritating properties of the test substance in rabbits. The substance has been determined to be not irritating to the skin.
Executive summary:

In a primary dermal irritation study (OECD guideline 404), male rabbits (three animals, New Zealeand White) were dermally exposed to 0.5g of substance in water. Animals then were observed for 7 days; irritation was scored by the method of Draize. The substance has been determined to be not irritating to the skin.