Registration Dossier
Registration Dossier
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EC number: 287-370-9 | CAS number: 85480-89-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a protocol which was equivalent to current guideline but not compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HLE protocol number P520/22/6/-/553/Rev.1
- GLP compliance:
- no
Test material
- Reference substance name:
- EDTMP-xCaxNa
- IUPAC Name:
- EDTMP-xCaxNa
- Reference substance name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
- EC Number:
- 287-370-9
- EC Name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
- Cas Number:
- 85480-89-3
- Molecular formula:
- C6H20-2x-yN2O12P4.xCa.yNa
- IUPAC Name:
- x calcium y sodium {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)
- Details on test material:
- - Name of test material (as cited in study report):
- Physical state: white powder
- Storage condition of test material: room temperature
- -EDTMP-xCa.xNa 26%, NaCl 12%, and water 62%. Phosphonate content ca. 92%.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: > 2kg
- Housing: Caged individually in grid floor cages in a single room with fan controlled air circulation.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): lower limit of 14
- Humidity (%): not controlled
- Photoperiod (hrs dark / hrs light): natural lighting conditions supplemented with fluorescent lighting during 8.45-17.00
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- The eyes were examined for signs of irritation 1, 2, 3, 4 and 7 days after treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: The irritation was scored according to Draize (1959).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal up to 72 hours
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/1 |
1/1/1/1/1/2 |
1/0/1/1/1/2 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/0/0/0/0/1 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/0/0/0/0/1 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0.1 |
0.6 |
0.3 |
Reversibility*) |
C |
C |
C |
C |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The test material was found mildly irritating in a study conducted according to a protocol which was equivalent to guideline, but not compliant with GLP.
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