Registration Dossier
Registration Dossier
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EC number: 600-813-6 | CAS number: 1072-68-0
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- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- 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
- 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
Constituent 1
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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