Registration Dossier

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:
3-methyl-1-p-tolyl-5-pyrazolone
EC Number:
201-708-4
EC Name:
3-methyl-1-p-tolyl-5-pyrazolone
Cas Number:
86-92-0
Molecular formula:
C11H12N2O
IUPAC Name:
5-methyl-2-(4-methylphenyl)-1,2-dihydro-3H-pyrazol-3-one

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Madörin AG, Füllingsdorf, Schweiz
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser system

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylenglycol 400
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test material (mixed with 0,35 ml vehicle)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0,35 ml vehicle (mixed with 500 mg test material)
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: adhesive plaster with cellulose patch wraped by use of semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes by use of lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:

Erythema: 0-4
Edema: 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 189, 191 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Irritation parameter:
erythema score
Basis:
animal: # 190
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal: # 189, 190, 191 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant, not corrosive to skin

Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008.
Executive summary:

Skin irritation/corrosion was tested according to OECD guideline 404. Following this protocol the test item (0.5 g mixed with 0.35 ml Polyethylenglycol 400) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four houres. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the test item. No skin reactions, neither erythema nor edema, were observed at any time point (all scores 0) with the exceptin of one animal that developed erythema grade 0.3. All signs of irritation were fully reversible within 48 h. No signs of sytemic toxicity were reported.