L-Ascorbic acid, 2-(dihydrogen phosphate), sodium salt (1:3)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1997-06-09 to 1997-07-16

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EEC

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

edition November 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-180-1

EC Name:

-

Cas Number:

66170-10-3

Molecular formula:

C6 H9 O9 P . 3 Na (CAS) C6 H6 Na3 P O9 (Hill)

IUPAC Name:

trisodium mono-(5-(1,2-dihydroxyethyl)-4-oxido-2-oxo-2,5-dihydro-furan-3-yl)phosphate

Details on test material:

- Name of test material (as cited in study report): Sodium Ascorbyl Phosphate
- Physical state: solid (powder), beige
- Analytical purity: 85.4 g/100 g (HPLC)
- Date of Manufacturing: 1997-05-02
- Lot/batch No.: 28600/37-9
- 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: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adult animals (2 females, 4 males)
- Weight at study initiation: 3.75 kg (mean)
- Housing: single housing, stainless steel wire mesh cages with grating, floor area: 3000 cm2, no bedding in the cages, sawdust in the waste trays
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: acclimatization for at least 1 week.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 H/12 H (6.00 A.M. - 6.00 P.M. / 6.00 P.M. - 6.00 A.M.)


IN-LIFE DATES: From: 1997-06-09 To: 1997-06-19

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.1 mL bulk volume (about 58 mg of the comminuted test substance)

VEHICLE
No vehicle used.

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

72 hrs

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The substance was washed out with tap water about 24 hours after application (before 24 hour reading)
- Time after start of exposure: 24 hrs


SCORING SYSTEM:
according to OECD guideline 405 (Adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992):
In addition to specific observations recommended by regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Area of cornea involved (ar):*
1 = >0; <=1/4
2 = >1/4; <1/2
3 = > 1/2 ; < 3/4
4 = > 3/4
* The assessment of these ocular reactions is performed independently of the quoted guidelines.

Discharge (di):*
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the Iids and hairs, and considerable area around the eye
* The assessment of these ocular reactions is performed independently of the quoted guidelines.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Remarks on result:

other: result for all animals and time points observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

2

Remarks on result:

other: result for all animals and time points observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24,48,72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24,48,72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: 24,48,72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

other: 24,48,72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 24,48,72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0.8

Max. score:

3

Reversibility:

fully reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

other: 24,48,72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible

Results 14

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 15

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 0.8 for conjunctivae redness and 0.1 for chemosis. The findings were reversible in all animals withing 72 hours after application, thus the study was terminated.

Other effects:

No mortality.

Any other information on results incl. tables

readings	animal	cornea		iris	conjunctiva			symptoms
		OP	AR		red	sw	di
1 h	01 02 03 04 05 06	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	1 2 1 2 1 1	1 1 0 1 1 1	2 1 1 1 1 1	- - - - - -
24h	01 02 03 04 05 06	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 2 2 2 1 2	0 0 0 1 0 0	0 0 0 0 0 0	- - - - - -
48 h	01 02 03 04 05 06	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 1 1 2 1 1	0 0 0 1 0 0	0 0 0 0 0 0	- - - - - -
72 h	01 02 03 04 05 06	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	- - - - - -
mean	01 02 03 04 05 06	0.0 0.0 0.0 0.0 0.0 0.0	0 0 0 0 0 0	0.0 0.0 0.0 0.0 0.0 0.0	0.0 1.0 1.0 1.3 0.7 1.0	0.0 0.0 0.0 0.7 0.0 0.0	- - - - - -	- - - - - -
mean	-	0.0		0.0	0.8	0.1	-	-

Calculation of the mean according to 93/21/EEC criteria of April, 27th, 1993 (for calculation of the means of corneal opacity, iris, redness and swelling of the conjunctiva only the readings of 24, 48 and 72 hours are used).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information