Propyloxirane

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: Guideline study (OECD 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(observation period: 8 days)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Propyloxirane

EC Number:

213-701-3

EC Name:

Propyloxirane

Cas Number:

1003-14-1

Molecular formula:

C5H10O

IUPAC Name:

2-propyloxirane

Details on test material:

- Name of test material (as cited in study report): n-Pentenoxid - 1,2
- Physical state: colourless, liquid
- Analytical purity: 99.9%
- Expiration date of the lot/batch: 10/1982
- Substance No.: 81/355
- Storage condition of test material: keep cool

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean(males): 3.23 kg, female: 2.80 kg
- Housing: single
- Diet: daily ca. 130 g Ovator Solikanin 4 mm / animal (Muskator-Werke)
- Water: daily ca. 250 mL / animal (VE-water: monday-friday, tap water: saturday/sunday)
- Acclimation period: ca. 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

8 days

Number of animals:

3 (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: dressing, which is permeable to air


REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 h (2 animals) / 8 days (1 animal)

Remarks on result:

other: scale formation at the end of the observation period

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 24 h (2 animals) / 48 h (1 animal)

Remarks on result:

other: scale formation at the end of the observation period

Other effects:

organs without findings

Any other information on results incl. tables

Exposition:	4 h, semi-occlusive
Animal	Reading	Erythema	Edema	Symptoms
1	4 h	2	1
2	4 h	2	1
3	4 h	2	1
1	24 h	1	0
2	24 h	1	0
3	24 h	2	1
1	48 h	0	0
2	48 h	0	0
3	48 h	1	0
1	72 h	0	0
2	72 h	0	0
3	72 h	1	0
1	8 d	0	0	scale formation
2	8 d	0	0	scale formation
3	8 d	0	0	scale formation
1	24/48/72 h	0.3	0
2	24/48/72 h	0.3	0
3	24/48/72 h	1.3	0.3
mean	24 - 72 h	0.67	0.10

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS