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Registration Dossier
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EC number: 205-745-7 | CAS number: 149-73-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-11-16 to 1992-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trimethyl orthoformate
- EC Number:
- 205-745-7
- EC Name:
- Trimethyl orthoformate
- Cas Number:
- 149-73-5
- Molecular formula:
- C4H10O3
- IUPAC Name:
- trimethoxymethane
- Details on test material:
- - Name of test material (as cited in study report): Trimethylorthoformiat (TMOF)
- Substance type: pure active substance
- Physical state: liquid, colorless
- pH: 5.02
- Water solubility: 10 g/liter
- Analytical purity: 99.8 area-% (method not stated)
- Impurities (identity and concentrations): no data
- Lot/batch No.: 20217, 222.1-263 / manufactured 1992-02-17
- Expiration date of the lot/batch: 1993 February
- Stability under test conditions: Sensitive to hydrolysis
- Storage condition of test material: Closed container, in hood
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleine Weisse Russen, strain Chbb:HM, SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Kleine Weisse Russen, strain Chbb:HM, SPF
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: conventional, individual animals in stainless steel cages
- Diet: ad libitum, Ssniff K 4 Alleindiaet fuer Kaninchen
- Water: communal drinking water ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1992-11-16 To: 1992-12-07
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3 liquid test substance placed into the conjunctival sac of one eye
- Untreated eye serves as control
VEHICLE
- none - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours, 6, 8, 10, 13, 17, 20 days after application
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with warm physiological saline
- Time after start of exposure: 24 hours after application (after fluorescein test)
FLUORESCEIN TEST
- 24, 48, 72 hours and 6 days after application
SCORING SYSTEM: OECD Guideline 405: Table 1: Grading of ocular lesions
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 20 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 20 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.45
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no changes at any time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
Any other information on results incl. tables
Time post application |
|
1 h |
|
|
24 h |
|
|
48 h |
|
|
72 h |
|
|
6 d |
|
8, |
10, |
13 d |
|
17 d |
|
|
20 d |
|
Animal |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Conjunctivae: erythema |
2 |
2 |
2 |
2 |
3 |
3 |
2 |
3 |
3 |
2 |
3 |
3 |
2 |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
||
Conjunctivae: chemosis |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
0 |
Cornea |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
2 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
0 |
Examination w. fluorescein |
|
|
0 |
3 |
4 |
0 |
3 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
|
|
|
|||||||
Exudation |
x |
x |
x |
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|||||||||
Exudation (white, slimy) |
x |
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctivae incl. nictitating membrane: bleeding |
|
|
|
slight |
severe |
severe |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
Iris: reddened |
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From the numerical scores of the individual animals at 24, 48, and 72 hours, the following averages were calculated:
|
Animal 1 |
Animal 2 |
Animal 3 |
Average |
Conjunctivae: erythema |
2.00 |
3.00 |
3.00 |
2.67 |
Conjunctivae: chemosis |
1.00 |
2.00 |
2.00 |
1.67 |
Iris |
0 |
0.67 |
0.67 |
0.45 |
Cornea |
0 |
1.00 |
1.33 |
0.78 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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