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EC number: 245-366-4 | CAS number: 22984-54-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Specific investigations
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 Aug 1983 - 11 Aug 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- yes
- Remarks:
- No sequential testing. Use of 9 animals (3 rinsed, 6 not rinsed).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butan-2-one O,O',O''-(methylsilylidyne)trioxime
- EC Number:
- 245-366-4
- EC Name:
- Butan-2-one O,O',O''-(methylsilylidyne)trioxime
- Cas Number:
- 22984-54-9
- Molecular formula:
- C13H27N3O3Si
- IUPAC Name:
- butan-2-one O,O',O''-(methylsilanetriyl)oxime
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Methyl Oximino Silane
- Physical state: colorless, viscous liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Pine Acres Rabbitry, Brattleboro, VT, USA
- Age at study initiation: 10-12 wk
- Weight at study initiation: 2.1-2.7 kg (based on age not weight)
- Housing: single housing
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: quarantine at least 2 wk, no further data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 50±15
- Air changes (per hr): 12-16
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1983-08-04 To: 1983-08-11
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye is generally used as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: neat - Duration of treatment / exposure:
- 3 rabbits had the treated eye washed for 1 min after 20 secs. The remaining 6 were unwashed.
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 h and daily until day 7 - Number of animals or in vitro replicates:
- 9 (3 washed, 6 unwashed)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the eyes of 3/9 were washed
- Time after start of exposure: 20 seconds
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Corneal opacity, circumcorneal injection of the iris, conjunctival redness, chemosis, and discharge was observed in 5 of 6 unirrigated eyes within 24 hours of treatment. All irritation associated with exposure to the test substance was reversible within 7 days. Rinsing test eyes with tap water 20 seconds following instillation appeared to be beneficial in that it prevented positive ocular irritation in 2 of the 3 additional animals. For details see table 1.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time until effects no longer evident (observations continued to day 7)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
1/0/1/0/1/1 |
1/1/1/0/1/1 |
1/2/2/1/1/2 |
24 h |
2/2/2/0/2/2 |
0/1/0/0/1/1 |
1/1/1/0/1/1 |
0/1/0/0/1/1 |
48 h |
1/1/2/0/2/1 |
0/0/0/0/1/1 |
1/1/1/0/1/1 |
0/0/0/0/0/0 |
72 h |
0/0/1/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/1 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
1 |
0.3 |
0.6 |
0.16 |
Reversibility* |
c |
c |
c |
c |
Time for reversion |
Day 4 |
72 h |
Day 4 |
48 h |
* Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- CLP Implentation.
- Conclusions:
- In a reliable eye irritation study, conducted in a manner similar to OECD 405 and with GLP (RL2) butan-2-one O,O',O''-(methylsilylidyne)trioxime was irritating to the eyes of rabbits based on 4/6 animals having a mean (24, 48 and 72 hour) score ≥1 for corneal effects.
- Executive summary:
An eye irritation study was conducted with a method similar to OECD guideline 405 in accordance to GLP-standards. The undiluted test substance was applied to one eye of nine New Zealand white rabbits, the untreated eye served as control. Three rabbits had the treated eye washed for 1 min after 20 secs. The remaining six were unwashed. The eye reactions were scored according to Draize system at 1, 24, 48, 72 hours and daily up to day 7 after the substance application. Corneal opacity, circumcorneal injection of the iris, conjunctival redness, chemosis, and discharge was observed in 5 of 6 unirrigated eyes within 24 hours of treatment. All irritation associated with exposure to the test substance was reversible within 7 days. Rinsing test eyes with tap water 20 seconds following instillation appeared to be beneficial in that it prevented positive ocular irritation in 2 of the 3 additional animals. It was concluded that the test substance is irritating to the eyes based on 4/6 animals having mean (24,48,72h) score ≥ 1 for corneal effects.
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