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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
92/69/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
edition November 1984
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24,48,72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24,48,72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24,48,72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24,48,72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24,48,72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24,48,72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
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