Reaction mass of 1,2-Diacetoxy-3-butene and 1,2-Dihydroxy-3-butene, monoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-03-14 - 2003-06-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD), GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

445-630-0

EC Name:

-

Molecular formula:

Unspecified

IUPAC Name:

1-(acetyloxy)but-3-en-2-yl acetate; 2-hydroxybut-3-en-1-yl acetate

Details on test material:

- Name of test material (as cited in study report): Vinylglykoldiacetat ca. 75%ig
- Analytical purity: 74.8 area% (73.3 g/100 g)
- Other constituents:
4-Acetoxy-3-hydroxy-1-butene and 2-Acetoxy-1-hydroxy-1-butene: 17.3 area-%.(17.0 g/100 g)
3,4-Diacetoxy butane: 2.0 area-% (2.0 g/100 g)
1-Acetoxy-2-hydroxy butane: 0.8 area-% (0.8 g/100 g)
2-Acetoxy-1-hydroxy butane : 0.4 area-% (0,3 g/100 g)
4-Acetoxy crotonaldehyd: 1.8 area-% (1.8 g/100 g)
- Test substance No.: 02/0526-1
- Lot/batch No.: 1, 2, 4, 5
- Date of production: Oct. 21, 2001
- Stability under test conditions: confirmed by reanalysis
- Storage condition of test material: temperature, exclusion of oxygen (storage under nitrogen)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lago S.A., 01540 Vonnas, France
- Identification: ear tattoo
- Age at study initiation: about 4 - 5 months
- Weight at study initiation: 3.22 - 3.27 kg
- Housing: individually in wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: at least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animals

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

4 hours

Observation period:

1, 24,48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsolateral part of the trunk
- Type of wrap if used: patch (2.5 cm x 2 .5 cm; Idealbinde, Pfälzische Verbandstoff- Fabrik, Kaiserslautern) was moistened with a dose of 0 .5 ml of the undiluted liquid test substance. The test patch was secured in position with a semiocclusive dressing (Fixomull® stretch adhesive fleece, Beiersdorf AG)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrole and Lutrol : water (1 : 1).
- Time after start of exposure: 4 h


OBSERVATIONS
Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays .


SCORING SYSTEM:
The evaluation of skin reactions is performed according to the quoted guidelines.


EVALUATION
For evaluation, the calculation of the mean values of erythema and edema for readings 24, 48 and 72 hours were quoted . Additionally, the reversibility of the observed findings was taken into account.
The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Results:

Readings	Animal	Erythema	Edema	Additional findings
0 h	1	2	0
	2	1	0
	3	1	0
1 h	1	2	0
	2	1	0
	3	1	0
24 h	1	2	0
	2	1	0
	3	1	0
48 h	1	1	0
	2	0	0
	3	0	0
72 h	1	0	0
	2	0	0
	3	0	0
mean 24 - 72 h	1	1.0	0.0
	2	0.3	0.0
	3	0.3	0.0
mean 24 - 72 h		0.6	0.0