[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

September 19, 1984

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

EC Number:

613-004-8

Cas Number:

62285-89-6

Molecular formula:

C28 H32 O2 P . Cl

IUPAC Name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

Details on test material:

- Name of test material (as cited in study report): C5-NPG-ACETAL
- Substance Number: 92/128
- Physical state: white powder
- Analytical purity: 99 %
- Lot/batch No.: 92/33 - 1 ((Technikum B 15 S)
- Stability under test conditions: The stability of the test substance in aqua bidest. for at least 4 hours was confirmed by analysis.
- Storage condition of test material: refrigerator; exclusion of moisture

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler; Offenbach, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: males: 2.75; 2.24 kg; female: 2.58 kg
- Housing: Single housing
- Diet (e.g. ad libitum): KLIBA Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): About 250 ml tap water per animal per day
- Acclimation period: for at least 1 week

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: At least 24 hours before the test, the fur was removed by clipping the dorsal of the trunk of the animals.

Vehicle:

other: moistened with aqua bidest

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged solid or semi-solid test substance and has been moistened with aqua bidest.

VEHICLE
- Amount(s) applied (volume or weight with unit): only moistened.
- Justification: because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological
conditions as possible.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males, one female

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: The test patch (2.5 cm x 2.5 cm) was covered with unchanged solid or semi-solid test substance
- Type of wrap if used: Fixomull® Stretch (adhesive fleece)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol® E400 (= Polyethyleneglycol DAB) and Lutrol®/water (1 : 1).
- Time after start of exposure: after 4 hours

SCORING SYSTEM: Draize system.

READINGS: 1, 24, 48 and 72 hours after removal of the patch

General observations: A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 0.2 for erythema and 0.0 for edema.
The findings were reversible within 72 hours, thus the study was terminated.

Other effects:

No other effects

Any other information on results incl. tables

Under the test conditions chosen and considering the described findings C5-NPG-Acetal does not give indication of an irritant property to the skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Classification: not irritating