Phosphoric acid, bis(phenylmethyl) ester, potassium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

1996-01-21

Test material

Test material information

Constituent 1

Reference substance name:

potassium dibenzyl phosphate

EC Number:

616-628-9

Cas Number:

78543-37-0

Molecular formula:

C14-H14-O4-P.K

IUPAC Name:

potassium dibenzyl phosphate

Test material form:

solid

Details on test material:

Batch 97/8

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 to 16 wekkks old
- Weight at study initiation: 2.73 to 2.92 kg
- Housing: individually housed in suspended metal cage
- Diet (e.g. ad libitum): free access to food (STANRAB SQC Rabbit diet, Special Diets Services Ltd, Withan, Essex, UK)
- Water (e.g. ad libitum): Free access
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 20 °C
- Humidity (%): 50% to 66%
- Air changes (per hr): approximately fifteen changes per hours
- Photoperiod (hrs dark / hrs light): 12h continuous light and 12h darkness

IN-LIFE DATES: From: To: 15 may 1997 and 29 may 1997

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: distilled water

Controls:

no

Amount / concentration applied:

0.5g of test material moitened with 0.5 mL of distilled water

Duration of treatment / exposure:

Pre-test: 3 minutes, 1h and 4h
Main test: 4h

Observation period:

24h and 72h, day 7 and14 after treatment

Number of animals:

3

Details on study design:

The substance was introduced under 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with strip of surgical adhesive tape (Blenderm: approximate size 2.5 cm x 4.0 cm).
To prevent animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset (Tubigrip) and the animal return to its cage for the duration of the exposure period.

Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

Approximately 1 hour following the removal of the patches, 24, 48 and 72h later, the test sites were examinated for evidence of primary irritaiton and scored according to the scale form Draize.

The scores for erythema and oedema at the 24 and 72h reading (4 hours exposure) were totalled for the three test rabbits (12 values) and this total was divided by six to gie the primary irritation index of the test material.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7d

Remarks on result:

other: 4-Hour exposure

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Reversibility:

fully reversible within: 7d

Remarks on result:

other: 4-Hour exposure

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72h

Remarks on result:

other: 4-Hour exposure

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Reversibility:

fully reversible within: 7d

Remarks on result:

other: 4-Hour exposure

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72h

Remarks on result:

other: 4-Hour exposure

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48h

Remarks on result:

other: 4-Hour exposure

Any other information on results incl. tables

Individual skin reaction following 4-hour exposure period

Skin reaction	Observation time	Individual Scores – Rabbit Number and Sex (BW in kg)			Total
		128 female (2.73)	108 female (2.78)	134 female (2.92)
Erythema / eschar Formation	1 hour	2 Hd	2	2	(6)
	24 hours	2 Hd	2	2	6
	48 hours	2 Hd	1	1	(4)
	72 hours	2 Hd	1	0	3
	7 days	0 Cf	0	0	(0)
	14 days	0	-	-	(0)
Oedema formation	1 hour	2	2	1	(5)
	24 hours	3	1	1	5
	48 hours	3	1	0	(4)
	72 hours	2	0	0	2
	7 days	0	0	0	(0)
	14 days	0	-	-	(0)
Sum of 24 and 72-hour reading (S) : 16
Primary Irritaion Index (S/6): 16/6 = 2.7
Classification: Moderate Irritant

( ) = Total values not used for calculation of primary irritation index

Hd = Small area of dermal haemorrhage, approximately 2mm x 4mm in size

Cf = crust formation

- = no data, observation not performed

 

Individual daily and mean scores for dermal irritation following 1-hour exposure

Skin reaction	Reading (h)	Individual Scores – Rabbit Number and Sex (BW in kg)
		128 female (2.73)	108 female (2.78)	134 female (2.92)
Erythema / eschar Formation	24	2	2	2
	48	2	1	1
	72	2	1	0
Total		6	4	3
Mean score		2.0+	1.3	1.0
Oedema formation	24	3	1	1
	48	3	1	0
	72	2	0	0
Total		8	2	1
Mean score		2.7+	0.7	0.3

+ = positive criterion

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the study, the dibenzyl Potassium Phosphate was not considered to be classified as irritant for the skin.

Executive summary:

The Skin irritation of the Dibenzyl Potassium Phosphate has been determinated according to OECD 404 test guideline in compliance with GLP.

The substance was determinated to be not irritant to the skin.