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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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-Dimethyl-1H-pyrazole
EC Number:
600-813-6
Cas Number:
1072-68-0
Molecular formula:
C5H8N2
IUPAC Name:
1,4-Dimethyl-1H-pyrazole
Details on test material:
- Name of test material (as cited in study report): 1,4-dimethylpyrazol
- Batch No.: ALB.J.NO.: TLJN 1020, Report NO.: LN 93-232
- Purity: 98.8%
- Physical state/appearance: Liquid, achromatic-yellowish
- Storage conditions: refrigerator

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: males 3.15 and 3.74 kg, and female 3.86 kg
- Housing: single housing, in stainless steel wire mesh cages with grating; floor area: 3000 cm2; no bedding in the cages; sawdust in the waste trays
- Diet: about 130 g per animal per day, Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL unchanged liquid test substance
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
2 males, 1 female
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap if used: the test substance has been covered with a test patch (idealbinde, pfaelzische verbandstoff-fabrik, Kaiserslautern) and Fixomull® stretch (adhesive sleeve), Beiderdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with lutrol® (Polyethylenenglycol DAB, BASF Aktiengesellschaft) and lutrol®/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: readings were performed 1 h, 24 h, 48 h, 72 h and 8 d after removal of the patch

GENERAL OBSERVATIONS: A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In animal #3 scaling was observed at the 72 h reading.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information

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