Phosphoric acid, dodecyl ester, potassium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16. Dec 1986 - 06. Jan 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP- and guideline-conform study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

test item was applied as 77% paste in water

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, dodecyl ester, potassium salt

EC Number:

254-414-3

EC Name:

Phosphoric acid, dodecyl ester, potassium salt

Cas Number:

39322-78-6

Molecular formula:

not applicable

IUPAC Name:

potassium dodecyl hydrogen phosphate

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Ag, Kastengrund, conventional breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3 - 3,4 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 (Altromin GmbH, Lage/Lippe, Germany) ad libitum, 15 g hay/day
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/-20 %
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 16. Dec. 1986 To: 06. Jan. 1987

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg of 77% test substance in water

Duration of treatment / exposure:

4 h

Observation period:

a. 30-60 min post applicationem
b. 24 h post applicationem
c. 48 h post applicationem
d. 72 h post applicationem
e. 7 d post applicationem
f. 14 d post applicationem
g. 21 d post applicationem

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
- Type of wrap if used: The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skinarea and covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.89

Max. score:

4

Reversibility:

fully reversible within: 21 d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 d

Other effects:

Treated skin areas were mostly dry and rough.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the reported scores and the reversibility of the observed effects the test item has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

The test item was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. The only deviation was that the test item was applied as 77% paste in water, but since according to the guideline dry powders have to be moistened, the testing conditions and results are considered to be the same. Effects on the skin (erythema grades up to 4 and edema scores up to 3) were observed in all animals 24 hours after application. These signs were reversible within the 21 days observation period.

With reference the reported scores and the reversibility of the observed effects the test item has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation, skin irritant category 2) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).