3-(3-hydroxypropyl)oxazolidin-2-one

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: OECD guideline study + GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(3-hydroxypropyl)oxazolidin-2-one

EC Number:

431-840-1

EC Name:

3-(3-hydroxypropyl)oxazolidin-2-one

Cas Number:

87010-29-5

Molecular formula:

C6 H11 N O3

IUPAC Name:

3-(3-hydroxypropyl)oxazolidin-2-one

Test material form:

other: viscous liquid

Details on test material:

- Name of test material (as cited in study report): Oxypropazone
- Physical state: Light yellowish, viscous liquid
- Analytical purity: 96.5%
- Lot/batch No.: #120446/7.12.90
- Stability under test conditions: According to information from the sponsor, the test substance was stable throughout the experimental period
- Storage condition of test material: The test substance was kept in a closed container at room temperature

Test animals

Species:

rabbit

Strain:

other: Russian white

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld
- Age at study initiation: Males 7 and 9 months, female 7 months
- Weight at study initiation: Males 2.47 kg and 2.59 kg, female 2.56 kg
- Housing: stainless steel cages woth grating floor, one animal per cage
- Diet: approximately 120 g/day/animal, Standard diet, sniff K, Special diet for rabbits
- Water: ad libitum
- Acclimation period: Animals were kept one day under test conditions before application of the test substance

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-24
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

Rabbits were score 1, 24, 48, 72 h and 3 days after test substance application

Number of animals:

three (two males, one female)

Details on study design:

TEST SITE

0.5 ml of the test substance was given on the left slte of the vertebral colunn. The site of application vas covered with a patch (6,25 cm2) conslsting of the following layers:
1. cellulose gauze
2. artificial wool coated wlth natural rubber
3. synthetic film glue
4. aluninium foi1.
Tbe opposlte area of the dorsal skin was treated in the same way but without test substance (control site). A bandage wrapped several times around the trunk (Acrylastic No. 2408, width 8 cm) provlded a complete occlusion. After the end of the exposition time remaining (4h) test material was gently washed off as far as possible.

SCORING SYSTEM:
The Draize method was used to assess the irrtiation score qualitatively (Erythema and edema) and quantitatively (values 0-4); furthermore, attention was given to the occurence of further skin reactions (e.g. corrosive effects) and to clinical symptoms (systemic toxic effects).
The arithmetical mean values of the individual grades obtained fron the skin areas at observation times 1, 24, 48 and 72 hours were
calculated - separately for erythena/eschar and edema formation. The irritation index is represented by the sum of these tvo mean values,
A corresponding gradatlon was allocated to this index by the folloving scheme using a modified method according to Gilman et al.
Index Ranges
0.0 0.5 0.6 3.0
3.1 s.0
5.1 8.0
Gradation
non-irritant
slightly irritant
noderately irritant
severely irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48,72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48,72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

During the observation neither edema nor erythema have been detected. The primary Irritation index is 0.0, the gradation result based on Gilman is "non-irritant"

Other effects:

Systemic toxic effects could not be detected. The general condition of the test animals was not affected

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item did not produce skin irritation in rabbits in an OECD404 guideline study