Oxazolidine, 3-butyl-2-(1-ethylpentyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-11-14 to 1995-11-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 17th 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31st 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-660-0

EC Name:

-

Cas Number:

165101-57-5

Molecular formula:

C14H29NO

IUPAC Name:

3-butyl-2-(heptan-3-yl)-1,3-oxazolidine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd, Manston
- Age at study initiation: 13-18 weeks old
- Weight at study initiation: 2.36-3.65 kg
- Housing: individually in single floor pens throughout the study
- Diet (e.g. ad libitum): SQC TRB Rabbit Diet 9603 (pelleted), ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: three to six weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL undiluted

Duration of treatment / exposure:

4 hours

Observation period:

8 days (all irritation reactions resolved within 7 days)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: clipped dorsum (30 x 20 mm area)
- Type of wrap if used: open weave, elasticated adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with moist cotton wool
- Time after start of exposure: 4 hours

SCORING SYSTEM:

Erythema and eschar

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness)
or eschar preventing reading of erythema 4

Oedema

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 mm) 3
Severe oedema (raised > 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:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

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:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Well defined erythema and very slight edema affected the dermal test site of one rabbit immediately after completion of a four hour exposure period. This dermal test site showed very slight erythema and very slight oedema one hour after treatment and very slight erythema alone 24, 48 and 72 hours after treatment. The other dermal test sites subjected to a four hour exposure to Incozol 2 showed no irritation reactions or other dermal changes.

Other effects:

No

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the skin irritation study on New Zealand white rabbits the test substance Incozol 2 is regarded to be non irritant to the skin.

Executive summary:

This study was conducted to determine the irritation/corrosion potential caused to the intact skin of rabbits following a single (4 hour) semi-occluded topical application of Incozol 2. The method followed was in compliance with that described EU Method B4 and OECD TG 404. A single rabbit was subject to a single topical application of 0.5 mL undiluted Incozol 2 at each of three closely clipped dermal test sites measuring 30 x 20 mm. The applied doses were covered by semi-occlusive dressings that remained in place for three minutes, one hour or four hours. Subsequently, two further rabbits were subject to a single semi-occluded topical application of the test substance at one dermal test site for four hours. The dermal test sites exposed to Incozol 2 for three minutes or one hour showed a very slight erythematous response that resolved within 24 hours of treatment. Well defined erythema and very slight edema affected the dermal test site of one rabbit immediately after completion of a four hour exposure period. This dermal test site showed very slight erythema and very slight edema one hour after treatment and very slight erythema alone 24, 48 and 72 hours after treatment. The other dermal test sites subjected to a four hour exposure to Incozol 2 showed no irritation reactions or other dermal changes. Therefore Incozol 2 does not classify as a skin irritant (Corning Hazleton, 1995).