Registration Dossier
Registration Dossier
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EC number: 240-212-2 | CAS number: 16068-37-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- EC Number:
- 240-212-2
- EC Name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- Cas Number:
- 16068-37-4
- Molecular formula:
- C14H34O6Si2
- IUPAC Name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology, Löhndorf, GERMANY
- Age at study initiation: 2.5-3.5 months
- Weight at study initiation: 1.6-1.9 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 55 +/-15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 2002-04-29 To: 2002-05-03
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye is the control in each case.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: neat - Duration of treatment / exposure:
- Single exposure, unwashed. Exposure until end of study (72 h).
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: After Draize, as given in OECD 405
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: each of 3 animals
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Minor (grade 1) corneal redness and chemosis in 1 of 3 animals at 1 h. No corneal or iridial effects. No other observations.
- Other effects:
- None.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctival redness |
Conjuctival chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/0/0 |
1/0/0 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Reversibility* |
- |
- |
c |
c |
Average time (unit) for reversion |
- |
- |
24 h |
24 h |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A reliable study, conducted according to OECD 405 and GLP, reported transient irritation - grade 1 corneal redness and chemosis at 1 h. The mean score (24, 48, 72 h) was 0/13 and 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane was found to be not irritating to the eyes of rabbits.
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