Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): pyrazolon
- Physical state: crystalline powder, light-beige
- Analytical purity: 100.5 g/100 g (H-NMR and IR spectroscopy)
- Storage condition of test material: room temperature, exclusion of light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Federal Republic of Germany
- Age at study initiation: young adults
- Weight at study initiation: 3.32 kg (animal 1), 3.42 kg (animal 2) and 3.87 kg (animal 3)
- Housing: single housing, stainless steel wire mess cages with grating
- Diet (e.g. ad libitum): about 130 g/animal/day (Kliba labor diet 341, regularly assayed for chemical and microbiological contaminants)
- Water (e.g. ad libitum): about 250 ml/animal/day (tap water, regularly assayed for chemical contaminants)
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C (there were no deviations from these ranges which influenced the results of the study)
- Humidity (%): 30 - 70% (there were no deviations from these ranges which influenced the results of the study)
- 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 of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): unchanged solid test substance moistened with water


Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm (upper third of the back or flanks)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed with polyethyleneglycol and polyethylenegylcol/water (1/1)
- Time after start of exposure: 4h


SCORING SYSTEM:
Readings: 1h, 24h, 48h, and 72 h after removal of the patch (scored according to OECD 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 48 h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicalbe

Any other information on results incl. tables

All animals had a erythema score of 1 and a edema score of 0 1h after the removal of the patch.

(For calculation of the means of erythema and edema score only the readings of 24, 48 and 72 hours are used.)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met