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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium triphosphate
EC Number:
231-838-7
EC Name:
Pentasodium triphosphate
Cas Number:
7758-29-4
Molecular formula:
H5O10P3.5Na
IUPAC Name:
pentasodium triphosphate
Details on test material:
- Name of test material (as cited in study report): Sodium tripolyphosphate
- Physical state: White granules
- Analytical purity: >99%
- Lot/batch No.: 587G005B

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
- Age at study initiation: Young adult
- Weight at study initiation: 2.29 - 2.59 kg
- Housing: Individually housed in suspended steel rabbit cages
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326 provided ad libitum
- Water (e.g. ad libitum): Fresh tap water provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 62 - 72
- Humidity (%): 32 - 57
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye of rabbit served as the control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
See details on study design
Observation period (in vivo):
1, 24, 48 and 72 hours and on day 4.
Number of animals or in vitro replicates:
4
Details on study design:
The eyes of two rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 ml of tap water approximately 20-30 seconds after treatment. Eyes were scored using the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
12
Remarks on result:
other: Unwashed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
6
Remarks on result:
other: Washed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
7
Remarks on result:
other: Unwashed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
0
Remarks on result:
other: Washed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 h
Score:
2
Remarks on result:
other: Unwashed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 h
Score:
0
Remarks on result:
other: Washed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 h
Score:
2
Remarks on result:
other: Unwashed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: Washed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: day 4
Score:
0
Remarks on result:
other: Unwashed
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: day 4
Score:
0
Remarks on result:
other: Washed

Any other information on results incl. tables

One hour after dosing severe discharge was noted in all eyes and mildchemosisand slight redness were present in unwashed eyes. Washed eyes recovered within 24 hours of dosing, while unwashed eyes had slight to mild conjunctivitis. One of the unwashed eyes had slight conjunctivitis through day three and recovered on day four at which time the test was terminated.

 

Individual eye scores

One hour

Animal number

Cornea Opacity/area

Iris

iritis

Conjunctiva

Redness

Chemosis

Discharge

B5306M

0/0

0

1

2

3

B5321M

0/0

0

1

2

3

B5309M (w)

0/0

0

0

0

3

B5313M (w)

0/0

0

0

0

3

 

Twenty four hours

Animal number

Cornea Opacity/area

Iris

iritis

Conjunctiva

Redness

Chemosis

Discharge

B5306M

0/0

0

2

0

2

B5321M

0/0

0

1

0

2

B5309M (w)

0/0

0

0

0

0

B5313M (w)

0/0

0

0

0

0

 

Forty eight hours

Animal number

Cornea Opacity/area

Iris

iritis

Conjunctiva

Redness

Chemosis

Discharge

B5306M

0/0

0

0

0

0

B5321M

0/0

0

1

0

1

B5309M (w)

0/0

0

0

0

0

B5313M (w)

0/0

0

0

0

0

 

Seventy two hours

Animal number

Cornea Opacity/area

Iris

iritis

Conjunctiva

Redness

Chemosis

Discharge

B5306M

0/0

0

0

0

0

B5321M

0/0

0

1

0

1

B5309M (w)

0/0

0

0

0

0

B5313M (w)

0/0

0

0

0

0

 

Day 4

Animal number

Cornea Opacity/area

Iris

iritis

Conjunctiva

Redness

Chemosis

Discharge

B5306M

0/0

0

0

0

0

B5321M

0/0

0

0

0

0

B5309M (w)

0/0

0

0

0

0

B5313M (w)

0/0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test material is temporarily approximated to be mildly irritating to unwashed eyes and non-irritating to washed eyes. Washing the eyes with tap water shortly after exposure decreased both the severity and the duration of the irritation observed.

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