Registration Dossier
Registration Dossier
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EC number: 239-590-1 | CAS number: 15541-60-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 2010 to 7 January 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- EC Number:
- 239-590-1
- EC Name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Cas Number:
- 15541-60-3
- Molecular formula:
- C3H6N6.xH4O7P2
- IUPAC Name:
- diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): MPP
- Appearance: White powder
- Analytical purity: 97.04%
- Lot/batch No.: G10170
- Storage conditions: room temperature, under dry conditions
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: reputable laboratory animal supplier
- Age at study initiation: 31 or 34 weeks
- Weight at study initiation: 3.69 to 4.30 kg
- Housing: each animal was housed individually in a plastic cage with perforated floors
- Diet: standard laboratory rabbit diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 12 or 20 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20
- Humidity (%): 40 to 0
- Air changes (per hr): continuous air supply
- Photoperiod (hrs dark / hrs light): 12 hours / 24 hour period
IN-LIFE DATES: From: 3 November 2010 To: 30 November 2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of each animal was used as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (approximately 92 mg) - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 15 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none - test substance not removed
SCORING SYSTEM:
Ocular irritation: cornea opacity 0-4; area of cornea 0-4
Corneal ulceration: iris 0-2; conjunctivae redness 0-3; chemosis 0-4
Discharge: 0-4
TOOL USED TO ASSESS SCORE: ophthalmoscope or pencil beam torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
A crimson-red conjunctival appearance was apparent in all animals throughout the first 48 hours after instillation persisting in two at the 72 hour examination; injection of the conjunctival blood vessels was apparent in all cases 24 hours later. Very slight to moderate chemosis was evident in all animals throughout the first 48 hours after instillation persisting in two at the 72 hour examination. Very slight to substantial discharge was also apparent during the first 72 hours after instillation.
Scattered or diffuse areas of opacity covering up to half the corneal surface were apparent in all animals 24 hours after instillation, persisting in one animal at the 48 hour examination and in the remaining animal at the 72 hour observation.
The treated eye of each animal was overtly normal 15 days after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- other: slightly irritating
- Remarks:
- Criteria used for interpretation of results: other: Kay and Calandra method (1962)
- Conclusions:
- The highest total mean score was 20.0 occurring at the 24 hour observation; accordingly under the criteria Kay and Calandra (1962) MPP was classified as “mildly irritating” to the eye.
At least 2 out of 3 animals showed a conjunctival redness score ≥2 and an oedema (chemosis) score ≥2 which was reversible within 21 days when. Calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material. MPP is therefore classified under CLP as Irritating to Eyes, Category 2.
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