Vanadyl pyrophosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with internationally recognised test methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vanadyl pyrophosphate

EC Number:

406-260-5

EC Name:

Vanadyl pyrophosphate

Cas Number:

58834-75-6

Molecular formula:

V2P2O9

IUPAC Name:

divanadium(4+) (phosphonatooxy)phosphonate dioxidandiide

Details on test material:

- Name of test material (as cited in study report): BTN/A
- Chemical name: Vanadyl pyrophosphate
- Chemical formula: (VO)2P207
- Relative molar mass: 307.8
- Physical state Fine, dark-brown powder
- Lot/batch No.:0003
- Purity: Vanadium - 30.1%, phosphorous 21.0% by weight
- Storage condition of test material: Cool, dry, well ventilated room

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Age at study initiation: circa 13 weeks
- Weight at study initiation: 2.92 - 3.34 kg
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): SQC rabbit diet from Special Diet Services, ad libitum
- Water (e.g. ad libitum): Municipal tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1990-03-26 To: 1990-04-16

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

1 day

Observation period (in vivo):

The behaviour of each rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response.
Ocular reactions to treatment assessed one hour, 24, 48 and 72 hours, 7 and 14 days after treatment.

Number of animals or in vitro replicates:

3 male

Details on study design:

Each animal was gently restrained. The dose was instilled into the right eye by pulling the lower eyelid away from the eyeball to form a cup into which 0.1 g of the test material was dropped. The eyelids were gently held together for one second and then released. The left eye remained untreated
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: Ophthalmoscope. Fluorescein staining used to assist in assessment of corneal lesions

Results and discussion

In vivo

Irritant / corrosive response data:

A beefy-red appearance to the conjunctiva, slight chemosis, slight discharge with mucus, iridial congestion, slight opacity covering up to one quarter of the cornea and two small areas of haemorrhage were observed by the 48 hour examination in one rabbit. Due to the severity of this response the animal was humanely killed immediately after this examination.

The other two surviving rabbits showed slight injection of the conjunctival blood vessels, a diffuse crimson-red and/or a beefy-red appearance to the conjunctivae until the 72 hour observation or Day 8, very slight and/or slight chemosis until the 24 hour examination and very slight and slight discharge until the 48 hour or 72 hour observations. Iridial congestion was apparent in both rabbits at the 24 hour and/or 48 hour examinations. One of these rabbits also displayed a slight opacity at the 24 hour observation, covering up to one quarter of the cornea. The eyes of the two surviving animals were overtly normal on Day 15.

Instillation of the test material caused very slight initial pain response.

Any other information on results incl. tables

INDIVIDUAL IRRITATION SCORES

Unwashed		Animal Number: 1207M
		Ocular reaction
Region of eye	Parameter	Hours				Days
		1	24	48	72	8	15
	Discharge:	2	2	1	1	0	0
Conjunctivae:	Chemosis:	1	2	0	0	0	0
	Redness:	1	2	1	1	1	0
Iris:	Inflammation:	0	1	0	0	0	0
Cornea:	Opacity:	0	1	0	0	0	0
	Area:	0	1	0	0	0	0

 

Unwashed		Animal Number: 1246M
		Ocular reaction
Region of eye	Parameter	Hours				Days
		1	24	48	72	8	15
	Discharge:	2	2	2
Conjunctivae:	Chemosis:	1	2	2
	Redness:	1	2	3
Iris:	Inflammation:	0	1	1
Cornea:	Opacity:	0	1	1
	Area:	0	1	1

 

Unwashed		Animal Number: 1247M
		Ocular reaction
Region of eye	Parameter	Hours				Days
		1	24	48	72	8	15
	Discharge:	2	2	1	0	0	0
Conjunctivae:	Chemosis:	1	1	0	0	0	0
	Redness:	1	3	2	1	0	0
Iris:	Inflammation:	0	1	1	0	0	0
Cornea:	Opacity:	0	0	0	0	0	0
	Area:	0	0	0	0	0	0

MEAN IRRITATION SCORES

Animal Number	Conjunctival Redness	Conjunctival Chemosis	Iris Inflammation	Corneal Opacity
1207M 1246M * 1247M	1.3 2.5 2.0	0.7 2.0 0.3	0.3 1.0 0.7	0.3 1.0 0.0
The mean score recorded for each animal is the average of the individual scores observed at the 24, 48 and 72 hour examinations (* with the exception of No. 1246M, terminated after 48 hours).

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance has an irritant effect on the eye with a degree of variation in severity of response elicited.

Although the mean scores recorded are insufficient to meet the criteria for classification as irritant under the EC classification scheme, the severity of the observed response in one animal was such that it has been proposed to classify the substance and apply the risk phrase R36. The revised criteria of GHS require classification as a category 2 eye irritant.

Executive summary:

Eye irritation has been investigated using OECD/EU test methods. The substance has an irritant effect on the eye with a degree of variation in severity of response elicited.

Although the mean scores recorded are insufficient to meet the criteria for classification as irritant under the EC (DSD) classification scheme, the severity of the observed response in one animal was such that it has been proposed to classify the substance and apply the risk phrase R36. The revised criteria of GHS require classification as a category 2 eye irritant.