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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cherschire, UK
- Age at study initiation: 12 to 16 wekks old.
- Weight at study initiation: 3.32 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): free access to food (STANRAB SQC rabbit diet, Special diets services Witham, Essex, UK)
- Water (e.g. ad libitum): Free access to water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): 51 to 70 %
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h continuous light and 12h darkness

IN-LIFE DATES: From: To: 2 june 1997 to 23 june 1997

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 mL

Observation period (in vivo):

Approximately 1h, 24, 48,72h after treament.
aditional observations were made on day 7, 14 and 21 to assess the reversibilty of the occul r effects.

Number of animals or in vitro replicates:

1 animal

Details on study design:

SCORING SYSTEM: Draize method
Examination of the eye was facilited by the use of a standard ophtalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 21d

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 21d

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 14d

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 21d

Results 5

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 1h

Score:

57

Reversibility:

not fully reversible within: 21 days

Any other information on results incl. tables

Areas of translucent corneal opacity were noted in the treated eye one hour after treatment with areas of diffuse corneal opacity at the 24 and 48-hour observation, area of translucent corneal opacity at the 7 and 14-day observations. Sloughing of the cornea was noted in the treated eye at the 72 -hour observation.

Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour and 7-day observations. No other iridial effects were noted.

Moderate conjunctival irritation was noted in the treated eye one hour after treatement and 24, 48, 72-hour and 7-day observations. Pale green discolouration of the nictitating and the conjunctival menbrane was noted in the treated eye one hour after treatment. An off white appearance of the nictating membrane and approximately half of the lower conjunctival membrane was noted in the treated eye at the 24, 48, 72-hour and 7-day observations. An aera of haemorrhage approximately 3 mm² in size on the conjunctival membrane of the lower eyelid was noted in the treated eye at the 48, 72-hour and 7-day obsevations. An abnormally shaped nictating membrane was noted in the treated eye at he 14 and 21-day observations.

Individual scored and total scores for ocular irritation

Rabbit Number and sex (Bodyweight kg)		IPR = 3
Time after treatment		63 Female (3.32)
		1 hour	24 hours	48 hours	72 hours	7 days	14 days	21 days
CORNEA	E = Degree of opacity	2	1	1	2SI	1	1	0
	F = Area of Opacity	4	4	4	3	3	1	0
	Score (E x F) x 5	40	20	20	30	15	5	0
IRIS	D	1	1	1	1	1	0	0
	Score (D x 5)	5	5	5	5	5	0	0
CONJUNCTIVAE	A = Redness	2G	2W	2WH	2WH	2WH	1AB	1AB
	B = CHEMOSIS	2	2	2	2	2	1	0
	C = Discharge	2	3	3	1	1	0	0
	Score (A+B+C) x 2	12	14	14	10	10	4	2
	Total Score	57	39	39	45	30	9	2

IPR = initial pain reaction

AB = Abnormally shaped nictitating membrane

G = Pale green discolouration of the nictitating and conjunctivalmembranes

H = area of haemorrhage approximately 3mm² located on conjunctival membrane of lower eyelid

W = off white appearance of nictitating membrane and approximately half of the lower conjunctival membrane

SI = sloughing of corneal membrane

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The dibenzyl Potassium Phosphate was considered to be corrosive to the eye.

Executive summary:

The eye irritation of Dibenzyl Potassium Phosphate has been determinated according to OECD 405 test guideline in compliance with GLP.

The substance was determinated to be corrosive to the eye.