Registration Dossier
Registration Dossier
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EC number: 616-639-9 | CAS number: 78620-07-2
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: conducted to OECD/EC guidelines with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Belcor 575 trisodium salt
- Physical state: Aqueous solution
- Aqueous sodium salt solution formed by neutralising acid with sodium hydroxide (52% Belcor 575, 48% NaOH)
- Lot/batch No.: PAD-A-240-226-D
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2310 - 2880 grams
- Housing: metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814
- Water (e.g. ad libitum): ad libitum fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- Test material was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control.
- Observation period (in vivo):
- 1, 24, 48, 72 hours.
- Number of animals or in vitro replicates:
- 3 male rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: not irritating
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: not irritating
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 2.22
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: not irritating
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.45
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: not irritating
Any other information on results incl. tables
The occular reactions were evaluated according to the OECD scoring system 1, 24, 48 and 72 hours after instillation of the test material. The test material induced irritation of the conjunctiva within 72 hours after instillation. The observation period was therefore extended to 7 days to determine the reversibility of the reactions. Because the mean values of the scores 24 to 72 hours after instillation are below the threshold of significance, the test material can be classed as non irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Trisodium [carboxy(oxido)methyl]phosphonate is not irritating to the eye.
- Executive summary:
In a primary eye irritation study 0.1 mL of Trisodium [carboxy(oxido)methyl]phosphonate was instilled into the conjunctival sac of three 9 -13 week old male New Zealand white rabbits for 72 hours. Animals then were observed for 7 days.
In this study, trisodium [carboxy(oxido)methyl]phosphonate is not an eye irritant
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