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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed GLP and OECD 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)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid
EC Number:
204-303-0
EC Name:
m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid
Cas Number:
119-17-5
Molecular formula:
C10H10N2O4S
IUPAC Name:
3-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): Pyrazolsäure 3 TF

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Hoechst AG breeding colony
- Number of animals: 3
- numbered earmarks
- Weight: 3.0 - 4.2 kg
- Age: ca. 3 - 5 months
- Housing: single cages in air conditioned rooms
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Diet: Altromin 2123 - rabbit, ad libitum, and hay (approx. 15 g/day).
- Water: deionized, chlorinated water from automatic feeders, ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
- Amount: 500 mg Pyrazolsäure 3 TF mixed with 0.2 ml of a 0.9 % NaCl solution.
Duration of treatment / exposure:
exposure period: 4 hours
removal of remnant test substance with lukewarm water at the end of the exposure period
Observation period:
30-60 minutes, 24, 48 and 72 hrs after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water after 4 hours of exposure

SCORING
- According to OECD TG

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: # 61, 62, 143 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritation parameter:
erythema score
Basis:
animal: # 61, 62, 143 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritant / corrosive response data:
no signs of irritation/corrosion
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Not irritating, not corrosive
Executive summary:

The test item was tested for skin irritation/corrosion in rabbits according to OECD guideline 404. 500 mg of the test item pasted with physiol. saline were applied to the clipped dorsal skin of 3 rabbits for 4 h under semiocclusive conditions. Thereafter the residual test item was removed using lukewarm tap water. Mean scores for edema and erythema were calculated (24, 48, and 72h) for each rabbit. During the entire observation period, no signs of irritaion or corrosion occured. Based on this findings the test substance was considered not to be irritant or corrosive to skin.