Uridine, 2'-deoxy-5-ethyl-, 3',5'-bis(4-chlorobenzoate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 31st, 2000 - December 15st, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Uridine, 2'-deoxy-5-ethyl-, 3',5'-bis(4-chlorobenzoate)

EC Number:

607-566-3

Cas Number:

25137-84-2

Molecular formula:

C25H22Cl2N2O7

IUPAC Name:

Uridine, 2'-deoxy-5-ethyl-, 3',5'-bis(4-chlorobenzoate)

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate)
- Physical state: Solid (Whitish crystalline powder)
- Lot/batch No.: 2/98-G
- Expiration date of the lot/batch: 30th November 2003
- Storage: At room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by, Charles River Italia S.p.A., (Como) and bred by P.O.A.D.A. Mandello Lario (CO)
- Age at study initiation: approximately 8 to 10 weeks
- Sex: females
- Weight at study initiation: 2 Kg
- Housing: stainless steel cages measuring 69 x 45 x 51 cm
- Diet: anti-biotic free pelleted laboratory diet (Altromin MSK, A. Rieper, Bolzano, Italy) ad libitum
- Water: drinking water ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light : 12 hours light /12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0,5 g

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 hours after dosing

Number of animals:

3 

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm
A 0.5 g aliquot of the test item was mixed to a paste using 2.0 mL of distilled water and spread evenly over a gauze square measuring 2.5x2.5 cm. The gauze square was then placed onto the animal’ s skin with the test item in direct contact with the skin. A strip of aluminium foil was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The treated site was cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature.
- Time after start of exposure: 4 h


SCORING SYSTEM:

Erythema and eschar formation Value
No erythema 0
Very slight erythema (barely perceptibie) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema 4

Oedema formation Value
No oedema 0
Very slight oedema (barely perceptibie) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No irritation or other reaction was apparent on the treated skin of any animal.

Other effects:

- Other adverse systemic effects: There was no indication of a systemic effect of treatment

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results of this study indicate that the test item, 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate), has no irritant effect on the skin of the rabbit.

Executive summary:

The acute dermal irritation of 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate) was investigated in the rabbit.

A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after the end of the exposure period.

No irritation was apparent following a 4 hour period of exposure to the substance.

There was no indication of a systemic effect of treatment.

Body weight changes were not remarkable.

These results indicate that 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate) has no irritant effect on the skin of the rabbit.