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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 29 May to 1 June 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
188416- 34-4
IUPAC Name:
188416- 34-4
Constituent 2
Reference substance name:
(2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
IUPAC Name:
(2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
Details on test material:
- Analytical purity: 96.5%
- Lot/batch No.: 5ABK-003

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10-13 weeks of age
- Weight at study initiation: 2.4-2.8 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19℃
- Humidity (%): 30-70%
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml distilled water
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Approximately 100 mm * 100 mm
- % coverage:
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment sites was washed with warm water (30 to 40 ℃) to remove any residual test substance.
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No reactions
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No reactions
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the observation period.

Any other information on results incl. tables

There were no signs of toxicity or ill health in any rabbit during the observation period.

Rabbit number and sex

E= Erythema

O= Oedema

Day

1*

2

3

4

2894 ♂

E

O

0

0

0

0

0

0

0

0

2895 ♂

E

O

0

0

0

0

0

0

0

0

2896 ♂

E

O

0

0

0

0

0

0

0

0

* Approximately 60 minutes after removal of the dressing.

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of this substance to intact rabbit skin for four hours elicited no dermal irritation.