Registration Dossier
Registration Dossier
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EC number: 221-336-6 | CAS number: 3069-29-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-336-6
- EC Name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-29-2
- Molecular formula:
- C8H22N2O2Si
- IUPAC Name:
- N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Sandbach, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 3.05 kg
- Housing: 1/suspended metal cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1987-11-09 To: 1987-11-09
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required - untreated eye is the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: neat - Duration of treatment / exposure:
- 30 mins. (Test animal sacrificed for humane reasons after 30 mins.)
- Observation period (in vivo):
- 30 mins
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not irrigated
SCORING SYSTEM: Draize (max 110)
TOOL USED TO ASSESS SCORE: light from standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 30 mins
- Score:
- 85
- Max. score:
- 110
- Reversibility:
- other: not possible to assess reversibility; unlikely to be reversible
- Remarks on result:
- other: one animal; observation 30 mins
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
- Irritant / corrosive response data:
- Total score (one rabbit @ 30 mins): 85/110. Opalescent corneal opacity, iridial inflammation, severe conjunctival irritation. See table 1.
- Other effects:
- Conjunctival blood stained discharge and haemorrhage. Haemorrhage from nictitating membranes.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for a single animal (study terminated at 30 mins)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
30 min |
3 |
1 |
3 |
4 |
3 |
Area effected |
4 |
- |
- |
- |
- |
Total score 85/110 |
60/80 |
5/10 |
20/20 |
||
Reversibility |
Not possible to assess; unlikely to be reversible |
||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- A reliable study, conducted according to OECD Test Guideline 405 and in compliance with GLP, reported corneal opacity, iridial inflammation and severe conjunctival irritation and a Draize score of 85 out of 110, in a single rabbit. The score was judged in the report to indicate that the test material was a very severe to extremely severe irritant to the eyes of rabbits, and would be considered to cause irreversible eye effects according to EU criteria.
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