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Registration Dossier
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EC number: 700-282-1 | CAS number: 66922-99-4
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: GLP guideline study Analytical purity not given, responsibility of the sponsor.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Analytical purity not reported, responsibility of the sponsor
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, 2009
Test material
- Reference substance name:
- tripotassium trihydrogen phosphate dihydrate
- EC Number:
- 700-282-1
- Cas Number:
- 66922-99-4
- Molecular formula:
- H304P.H20.3/2K
- IUPAC Name:
- tripotassium trihydrogen phosphate dihydrate
- Details on test material:
- - Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given, responsibility of the sponsor
- Lot/batch No.: 9086
- Storage condition of test material: RT in the dark under nitrogen
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.03 - 2.50 kg
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL corresponding to 92 mg (as measured by gently compacting the required volume into an adapted syringe) - Duration of treatment / exposure:
- Single treatment without washing
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Other effects:
- No systemic toxicity, abnormal body weight changes or clinical signs were observed during the study period.
Any other information on results incl. tables
Table 1: Individual scores
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
1 |
1 |
0 |
0 |
2 |
2 |
|
24 |
0 |
0 |
1 |
1 |
|
48 |
0 |
0 |
1 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
168 |
0 |
0 |
0 |
0 |
|
Mean 24-72 h |
0 |
0 |
0.66 |
0.33 |
2 |
1 |
0 |
0 |
2 |
2 |
|
24 |
0 |
0 |
1 |
1 |
|
48 |
0 |
0 |
1 |
1 |
|
72 |
0 |
0 |
1 |
0 |
|
168 |
0 |
0 |
0 |
0 |
|
Mean 24-72 h |
0 |
0 |
1 |
0.66 |
3 |
1 |
0 |
0 |
2 |
2 |
|
24 |
0 |
0 |
1 |
1 |
|
48 |
0 |
0 |
1 |
1 |
|
72 |
0 |
0 |
1 |
0 |
|
168 |
0 |
0 |
0 |
0 |
|
Mean 24-72 h |
0 |
0 |
1 |
0.66 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Although slight, reversible irritation was observed, the test substance has not to be classified according to DSD and CLP.
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