Registration Dossier
Registration Dossier
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EC number: 237-864-5 | CAS number: 14025-15-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relatively well reported study, no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)
- EC Number:
- 237-864-5
- EC Name:
- Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)
- Cas Number:
- 14025-15-1
- Molecular formula:
- C10H12CuN2O8.2Na
- IUPAC Name:
- Copper(2+) ion disodium 2-({2-[bis(carboxylatomethyl)amino]ethyl} (carboxylatomethyl)amino)acetate
- Test material form:
- solid - liquid: suspension
- Details on test material:
- Name: TRILON B-CU 15
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: two males (2.62 and 2.73 kg), one female (2.96 kg)
- Housing: 1 per cage (stainless steel)
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Test system
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml bulk volume was applied (ca. 61 mg of the comminuted test substance)
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- Up to 8 days; scoring at 1, 24, 48, and 72 h and 8 days after application
- Number of animals or in vitro replicates:
- 3 (2 males, 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable
SCORING SYSTEM: according to 83/467/EEC
TOOL USED TO ASSESS SCORE: no info
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below
- Other effects:
- No info
Any other information on results incl. tables
Summary of ocular lesions
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3
|
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||||
1 |
1 |
2 |
3 |
8 |
|
|
|
|
|
||
1 (M) |
Cornea Iris Redness Chemosis |
0 0 2 2 |
1 0 2 1 |
1 0 2 0 PC |
1 0 1 0 |
0 0 0 0 |
|
1.00 |
0 |
1.67 |
0.33 |
2 (F) |
Cornea Iris Redness Chemosis |
0 0 2 2 |
1 0 2 2 |
1 0 1 1 |
0 0 1 0 |
0 0 0 0 |
|
0.67 |
0 |
1.33 |
1.00 |
3 (M) |
Cornea Iris Redness Chemosis |
0 0 2 2 PC |
1 0 2 2 PC/S |
1 1 2 1 PC/S/DC |
1 1 2 1 PC |
1 0 1 0 |
|
1.00 |
0.67 |
2.00 |
1.33 |
Mean all anim. |
|
|
|
|
|
|
|
0.89 |
0.22 |
1.67 |
0.89 |
PC = pupil contracted, DC= detachment of the cornea, S = suppuration
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Because two animals out of three showed corneal opacity >= 1 calculated as the mean score following grading at 24, 48 and 72 h after instillation and is expected to be fully reversible within an observation period of 21 days, the test material needs to be classified as eye irritant Cat. 2 (2A).
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