Registration Dossier

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:
other: Test performed before GLP guideline implementation. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Company guideline and § 1500.41 of Federal Register 38, No. 187, 27.9.1973, p 27019
Deviations:
no
GLP compliance:
no
Remarks:
previous to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(3-methyl-5-oxo-2-pyrazolin-1-yl)benzenesulphonic acid
EC Number:
201-901-3
EC Name:
4-(3-methyl-5-oxo-2-pyrazolin-1-yl)benzenesulphonic acid
Cas Number:
89-36-1
Molecular formula:
C10H10N2O4S
IUPAC Name:
4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzenesulfonic acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 2,3 - 3.1 kg
- Housing: single caged
- Diet: standard diet ERKA Z-6000 ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved intact or shaved abraded with a scarifying instrument
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): moistened with 0.25 mL physiological saline
Duration of treatment / exposure:
Removal of the patch: 24 h after application
Observation period:
72 h
Number of animals:
6
Details on study design:
0.5 g of the test substance, moistened with 0.25 mL physiological saline, is spread on a gauze patch, measuring 2,5 x 2,5 cm which is applied on the abraded and intact skin of 6 albino rabbits, clipped free of hair (6 x 3 cm) under occlusive conditions. After 24 hours of exposure, the patches are removed and reactions are recorded. Readings are made again 48 and 72 hours after application.
(Abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (erythema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (erythema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (erythema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (erythema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (edema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (edema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (edema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (edema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (edema) were observed at any time
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean of 24 and 48 h after patch removal
Score:
0
Max. score:
4
Reversibility:
other: Reversibility is inapplicable since no signs of irritation (edema) were observed at any time
Remarks on result:
other: intact skin
Irritant / corrosive response data:
24 h p.a. the skin was discoloured brownish and 48 to 72 h p.a. yellowish discolouration was noted.

Score values of the abraded skin were similar.
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: EU
Conclusions:
The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008
Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g of the test substance, moistened with physiolocical saline, for 24 h under occlusive conditions.The skin responses were recorded 24 h, 48 and 72 after application (i.e. 0, 24 and 48h after patch removal). Beside brownish and yellowish discoloration of the skin in all animals erythema grade 1 were observed in 4 animals (abraded skin) and 2 animals (intact skin). All signs of irritation were fully reversible within the observation period of 72 h.

Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.