3-methyl-1-p-tolyl-5-pyrazolone

Skin irritation / corrosion

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

Test material information

Constituent 1

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:

3-methyl-1-p-tolyl-5-pyrazolone

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

Results

Results 1

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

Results 2

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

Results 3

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.