Phosphoric acid, 2-ethylhexyl ester, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1987-03-04 to 1987-03-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, 2-ethylhexyl ester, sodium salt

EC Number:

269-044-8

EC Name:

Phosphoric acid, 2-ethylhexyl ester, sodium salt

Cas Number:

68186-64-1

Molecular formula:

C8 H18 O . x H3 O4 P . x Na

IUPAC Name:

.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by Cassella AG, labeled: CA799

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.60 - 2.89 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum rabbit diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 45
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm, dorsal /flank area
- Type of wrap: gauze patch, animals were wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool and distilled water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48, 72 hours and 7 days after removal of the patch

SCORING SYSTEM:
Draize J.H. (1959) Association of Food and Drug OfficÍals of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: desquamation was observed from 48 h onwards until termination of the study

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: desquamation was observed on day 7

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

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:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Well-defined erythema with very slight oedema was noted at two application sites one hour after treatment and at one application site at subsequent 24 and 48-hour observations, very slight erythema was also noted at this application site at the 72-hour observation. Very slight erythema with very slight oedema was noted at the remaining application site one hour after treatment, and at the 24-hour observation. One application site showed desquamation at the 48 and 72-hour observations, with desquamation at two application sites on day seven.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating on the rabbits' skin.

Executive summary:

The study was performed according to OECD Guideline 404 to assess the irritancy potential of the test material following a single 4-hour, semi-occluded application to the intact rabbit skin of three New Zealand White rabbits. After removal of the patch and washing of the test site, skin reactions were scored after 1, 24, 48, 72 hours and on day 7. As a result, only slight reactions were recorded (mean values over the time points 24/48/72 h: erythema, animal 1/2/3: 0.3 / 0.3 / 1.7; edema: 0.3 / 0 / 0.7). As the reactions were reversible until day 7, the study was terminated. As a conclusion, the test substance is not irritating to skin.