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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:
15 July - 28 July 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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 (incl. QA statement)

Test material

Constituent 1
Reference substance name:
4-chloro-6-ethyl-5-fluoropyrimidine; dichloromethane
EC Number:
929-144-0
IUPAC Name:
4-chloro-6-ethyl-5-fluoropyrimidine; dichloromethane
Test material form:
liquid
Details on test material:
Clear yellow liquid
Storage conditions: Room temperature in the dark
Specific details on test material used for the study:
Clear yellow liquid
Storage conditions: room temperature in the dark
Bach number: 5494/95/2

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
They were in the weight range of 2.6 to 3.0 kg and approximately 11 to 13 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment for a period of 20 days prior to the start of the study. The rabbits were selected without conscious bias for the study. They were housed individually in stainless steel cages with perforated floors. A standard laboratory rabbit diet and drinking water were provided ad libitum. Animal room temperature was maintained at 17.5 to 23.5°C and relative humidity at 42 - 74%. Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. Each animal was identified by a numbered aluminium tag placed through the edge of one ear.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Approximately 0.5 ml of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact site on each animal.
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 females
Details on study design:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.

Approximately 0.5 ml of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact site on each animal.

Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.

At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (38°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 945
Time point:
14 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal: 945
Time point:
14 d
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 946
Time point:
14 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal: 946
Time point:
14 d
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 947
Time point:
14 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal: 947
Time point:
14 d
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14days
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14days
Irritant / corrosive response data:
DERMAL RESPONSES
Well-defined erythema with moderate oedema was seen in all animals. These reactions were accompanied in all rabbits by thickening of skin. Responses gradually ameliorated, however very slight erythema was persistent in all animals to study termination on Day 14.
Other effects:
CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
A single semi-occlusive application of UK-103,444 to intact rabbit skin for four hours elicited moderate dermal irritation.
Executive summary:

UK-103,444 will require labelling with the risk phrase of GHS classification of Skin irrit. category 2, H-315: "Causes skin irritation".