Vanadate(1-), oxo[phosphato(3-)-.kappa.O]-, hydrogen, hydrate (2:2:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Divanadyl pyrophosphate

EC Number:

407-130-0

EC Name:

Divanadyl pyrophosphate

Cas Number:

65232-89-5

Molecular formula:

(VO)2P2O7

IUPAC Name:

Divanadyl pyrophosphate

Details on test material:

- Physical state: greyish-green powder
- Analytical purity: 100%
- Lot/batch No.: 3883559 A
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton-Dutchland Inc., Denver, Pennsylvania.
- Age at study initiation: young adults (at least 8 weeks old)
- Weight at study initiation: no data
- Housing: individually
- Diet: Lab Rabbit Chow HF (Purina #5326), 125 g/day while on test.
- Water: tap water, ad libitum.
- Acclimation period: 56 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the adjacent eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 cm3

Duration of treatment / exposure:

Single application

Observation period (in vivo):

max. 28 days

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Approximately 24 h after application, the treated eyes were rinsed to remove any residual test application.

SCORING SYSTEM: draize score, with the following deviations:

Cornea:
Opaclity - degree of density
No opacIty = 0
SIight dulling of normal luster = +
Scattered or difuse areas of opacity (other than slight dulling of normal luster). details of iris clearly visible . = 1*
Easily discerniole transluscent areas; details of iris slightly obscured = 2*
Nacrous area. no detalles of iris visible, size of pupil barely discernible = 3*
Opaque cornea, iris not discernisle through opacity = 4*

Iris
Normal = 0
Slight deepening of the rugae or slight hyperemia of the circumcorneal blood vessels = +
Markedly deepened folds (above normal). congestion, swelling, moderate circumcorneal hyperemia or injection (any or all of these or combination of thereof), iris still reacting to light (sluggish reaction is positive} = 1*
No reaction to light, hemorrhage, gross destruction (any or all of these} = 2*

"*" = Score considered positive;
"+" = Not included in SPA grading system, values assigned if finding present.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 28 days in 3 of 6 animals

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1.1

Max. score:

2

Reversibility:

fully reversible within: 28 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

2.7

Max. score:

3

Reversibility:

not fully reversible within: 28 days in 3 of 6 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

2.4

Max. score:

4

Reversibility:

not fully reversible within: 28 days in 2 of 6 animals

Other effects:

The test substance caused serious damage to eyes. All six animals exhibited severe conjunctival irritation (redness, chemosis, discharge, necrosis), corneal opacity, ulceration and iridial damage. All six animals also exhibited pannus (vascularized connective tissue like excrescence) one or more times between days 7 and 28. On day 7 one animal had an enlarged blood vessel on the anterior surface of the iris. Two animals had a fluid filled blister on the corneal surface on day 21 and/or 28. Three animals were noted to have hair loss around the eye. All six animals continued to exhibit severe irritation at termination of the study (day 28).

Any other information on results incl. tables

Findings animals 1/2/3/4/5/6 (undiluted test substance):

Time	Opacity	Iritis	Conjunctival  Erythema		Conjunctival Chemosis
1 h	+/+/+/0/+/+	+/0/+/+/0/+	2/1/1/1/1/1		0/0/0/0/0/1
24 h	2/1/2/2/2/2	1/1/1/1/1/1	3/3/3/3/3/3		3/3/3/3/3/3
48 h	2/+/2/1/2/2	2/1/1/1/1/1	3/3/3/2/2/3		3/2/3/2/2/2
72 h	2/+/1/+/+/+	2/1/1/1/+/1	3/2/3/2/2/2		2/2/2/2/2/2
7 d	4/+/1/2/+/1	2/1/1/1/0/+	2/2/2/2/1/2		1/1/2/1/1/1
14 d	2/+/2/1/0/0	2/1/1/0/0/0	2/2/2/2/2/1		2/1/1/1/0/0
21 d	+/+/1/1/0/0	1/0/0/0/0/0	1/1/1/1/1/1		1/0/0/1/0/0
28 d	2/+/2/2/0/0	0/0/0/0/0/0	1/1/0/1/0/0		1/0/0/1/0/0