Phosphoric acid, mono- and di-C16-18-alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 27/7/2005 to 15/9/2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP 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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, mono- and di-C16-18-alkyl esters

EC Number:

291-938-1

EC Name:

Phosphoric acid, mono- and di-C16-18-alkyl esters

Cas Number:

90506-73-3

IUPAC Name:

90506-73-3

Test material form:

solid: pellets

Details on test material:

- Physical state: white solid pellet
- Analytical purity: 100 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Granja Cunícula San Bernardo s.L
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.3-2.6 kg
- Housing: individually in stainless steel cages with a grille floor placed on racks.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test item

Duration of treatment / exposure:

At first only one animal was used, applying three patches sequently for 3 minutes, 1 and 4 hours. After each one of these exposure periods, the corresponding bandage and patch were removed. The remaining test item was remioved with water. The test was completed using two other animals, applying a dressing to each one for 4 hours. After this exposure period, the bandages and patches were removed. The remaining test item was removed wih water.

Observation period:

The response in the application area was assessed after 60 minutes, 24, 48 and 72 hours after the period of exposure.

Number of animals:

Three female

Details on study design:

TEST SITE
- Area of exposure: 6.2 cm^2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

other: 60 min

Score:

0.33

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

other: mean 24, 48 and 72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

other: mean 24, 48, 72 h

Score:

0

Irritant / corrosive response data:

At first only one animal was used and after 4 hours exposure to the test item, very slight erythema (hardly noticeable) (grade 1) was recorded one hour after removing the patch.

Any other information on results incl. tables

Primary Dermal Irrtation Test
Nº animal (Exposure)	Response	60 min	24 h	48 h	72 h
2267 (3 minutes)	Erythema	0	0	0	0
	Edema	0	0	0	0
2267 (1Hour)	Erythema	0	0	0	0
	Edema	0	0	0	0
2267 (4hours)	Erythema	1	0	0	0
	Edema	0	0	0	0
Primary Dermal Irrtation Test
Nº animal (Exposure)	Response	60 min	24 h	48 h	72 h
2267	Erythema	1	0	0	0
	Edema	0	0	0	0
2269	Erythema	0	0	0	0
	Edema	0	0	0	0
2271	Erythema	0	0	0	0
	Edema	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The test item is considered to be NON IRRITANT based on the criteria set out in Directive 2001/59/EC, Annex VI, and CLP, EU GHS (Regulation (EC) No 1272/2008)

Executive summary:

In a primary dermal irritation study according to the OECD Guideline for the Testing of Chemicals 404 and Commission Directive 2004/73/EC Method B.4, 3 female, young adult New Zealand white rabbits were dermally exposed to 0.5 g of Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters (100% a.i.) for 3 minutes, 1 and 4 hours to 6.2 cm² skin surface. Animals then were observed for 3 days.

No skin lesions were recorded after removing the patches applied for 3 minutes and 1 hour in the observation carried out 1 hour after removing the patches. After the 4 hour exposure to the test item, very slight erythema (hardly noticeable) (grade 1) was observed one hour after removing the patch. No skin lesions were observed in this animal during the observations made 24, 48 and 72 hours after removing the patches applied for 3 minutes, 1 hour or 4 hours. A semiocclusive patch with test tem was applied for 4 hours in the other two animals. No skin lesions were recorded in any of the animals during the observations made 1, 24, 48 and 72 hours after removing the patch. The means of the erythema and edema evaluations at 24, 48 and 72 hours for the three animals after a four-hour exposure were 0.00 (erythema) and 0.00 (edema).

In this study Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters are not irritating to rabbit skin.