Registration Dossier
Registration Dossier
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EC number: 231-838-7 | CAS number: 7758-29-4
Eye irritation
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:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- 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 bis(phosphonatooxy)phosphinate
- 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
Constituent 1
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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