Potassium hexadecyl hydrogen phosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-03-08 until 2005-03-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 2004-04-29

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2002-04-24

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hexadecyl hydrogen phosphate

EC Number:

242-768-1

EC Name:

Potassium hexadecyl hydrogen phosphate

Cas Number:

19035-79-1

Molecular formula:

C16H35O4P.K

IUPAC Name:

potassium hexadecyl hydrogen phosphate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353, 88353 kißlegg
- Weight at study initiation: 2.0-2.4 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in in battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours light / dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

other: sesame oil was used as a vehicle for pasting the test item

Controls:

not required

Amount / concentration applied:

Single dose of 0.5 g of the test substance (pasted with 0.3 mL sesame oil)

Duration of treatment / exposure:

4 hours

Observation period:

60 minutes and 24, 48, 72 hours after removal of the patches.

Number of animals:

3 animals

Details on study design:

TEST SITE
The test item was evenly distributed over the whole surface of a 2.5 x 2.5 cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
After the exposure period all remainings of the test item were carefully removed from the skin with warm tap water.

SCORING SYSTEM:
Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded as well.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

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:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Basis:

mean

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:

No signs of irritations were observed during the study

Any other information on results incl. tables

An initial test was performed using one animal. As no corrosive effects were observed in the initial test a confirmatory test with two further animals was conducted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study the test substance is not irritating to skin.

Executive summary:

An initial test was performed using one animal. As no corrosive effects were observed in the initial test a confirmatory test with two further animals was conducted. Altogether, 3 female New Zealand White rabbits were tested for skin irritation according to OECD Guideline 404 and EU Method B.4 with 0.5 g of the test substance moistened in 0.3 mL sesame oil per animal for an exposure period of 4 hours. No signs of irritation were observed occurred during the whole observation period. Based on the system of evaluation defined by EC, the following overall mean scores for dermal irritation after 24, 48 and 72 hours were calculated: Erythema and eschar formation - 0 and Edema formation - 0. It can be concluded, based on the results of this study that the test substance is not imtating to skin of rabbits.