Sodium metaphosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From: 01/04/1986 To: 05/04/01986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FMC Preliminary Eye Irritation Protocol dated March 17, 1986

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

see deviations in any other information on materials and methods.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium metaphosphate

EC Number:

233-343-1

EC Name:

Sodium metaphosphate

Cas Number:

10124-56-8

Molecular formula:

H6O18P6.6Na

IUPAC Name:

Sodium metaphosphate

Details on test material:

- Name of test material (as cited in study report): Sodium Hexametaphosphate
- Substance type: White granules
- Physical state: Solid
- Analytical purity: >99%
- Lot/batch No.: 571G029B
- Stability: Stable indefinitely
- Storage condition of test material: Room temperature in dry area

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, Pennsylvania on February 26 and March 19, 1986
- Age at study initiation: Young rabbits.
- Weight at study initiation: 2.52kg - 3.26 kg
- Housing: The animals were individually housed in suspended stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9°C-25°C (reported as 66°F to 77°F)
- Humidity (%): 32%-55%
- Photoperiod (hrs dark / hrs light): 12 fluorescent light and 12 hour dark cycle.


IN-LIFE DATES: From: 26/02/1986 To: 05/04/1986

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated left eyes of the animal's served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg per eye

Duration of treatment / exposure:

Two of the rabbits were exposed for 20-30 seconds before having their eye's rinsed.
Two of the rabbits did not have their eyes washed during the course of the study - 72 hours.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Four animals, two did not have their eyes washed, the other two did.

Details on study design:

REMOVAL OF TEST SUBSTANCE
Two of the four exposed animals had their eyes was 20-30 seconds after exposure.

SCORING SYSTEM:
The eyes were scored for irritation potential using the method of Draize J.H., G. Woodard and H.O. calvery, J. Pharmacol. Exp. ther., 83, 387 (1944).
The Primary Eye Irritation Index was calculated according to Novermber, 1984, U.S. E.P.A. Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Series 81-4.

TOOL USED TO ASSESS SCORE: After the 24 hour examination with a penlight type light, the eyes were examined with the aid of fluorescein dye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after dosing, both of the unwashed eyes had severe discharge, one of which also had slight chemosis; both of the washed eyes exhibited slight discharge. At the 24-hour and 48-hour scorings, one of the unwashed eyes had a slight discharge. At the 72-hour scoring all irritation had resolved and the test was terminated.

Other effects:

No data.

Any other information on results incl. tables

Table 1 - eye examination, individual scores at one hour

Animal Number	Cornea	Iris	Conjunctiva
	Opacity/Area	Iritis	Redness	Chemosis	Discharge
Male 1	0/0	0	0	1	3
Male 2	0/0	0	0	0	3
Male 3 (w)	0/0	0	0	0	1
Male 4 (w)	0/0	0	0	0	1

(w) - denotes that the eyes of the animal were washed.

Table 1 continued – results at twenty-four hours

Animal Number	Cornea	Iris	Conjunctiva			Cornea
	Opacity/Area	Iritis	Redness	Chemosis	Discharge	Stain/area
Male 1	0/0	0	0	0	1	0/0
Male 2	0/0	0	0	0	0	0/0
Male 3 (w)	0/0	0	0	0	0	0/0
Male 4 (w)	0/0	0	0	0	0	0/0

(w) - denotes that the eyes of the animal were washed.

Table 1 continued – results at forty-eight hours

Animal Number	Cornea	Iris	Conjunctiva			Cornea
	Opacity/Area	Iritis	Redness	Chemosis	Discharge	Stain/area
Male 1	0/0	0	0	0	1	NA
Male 2	0/0	0	0	0	0	NA
Male 3 (w)	0/0	0	0	0	0	NA
Male 4 (w)	0/0	0	0	0	0	NA

(w) - denotes that the eyes of the animal were washed.

Table 1 continued – results at seventy-two hours

Animal Number	Cornea	Iris	Conjunctiva			Cornea
	Opacity/Area	Iritis	Redness	Chemosis	Discharge	Stain/area
Male 1	0/0	0	0	0	0	NA
Male 2	0/0	0	0	0	0	NA
Male 3 (w)	0/0	0	0	0	0	NA
Male 4 (w)	0/0	0	0	0	0	NA

(w) - denotes that the eyes of the animal were washed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the author concludes that the test material is temporarily approximated to be minimally irritating to unwashed eyes and non-irritating to washed eyes. Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed.
Although the study has only been conducted on two animals (unwashed eyes) it is considered to be sufficient for classification and labelling due to the minimal effects noted. This study is therefore submitted as a key study to provide the relevant classification according to Regulation (EC) No. 1272/2008 (EU CLP)