Registration Dossier
Registration Dossier
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EC number: 219-909-0 | CAS number: 2568-90-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 20. Aug 1968 - 28. Aug 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
- Principles of method if other than guideline:
- Method: BASF test
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,1'-[methylenebis(oxy)]dibutane
- EC Number:
- 219-909-0
- EC Name:
- 1,1'-[methylenebis(oxy)]dibutane
- Cas Number:
- 2568-90-3
- Molecular formula:
- C9H20O2
- IUPAC Name:
- 1,1'-[methylenebis(oxy)]dibutane
- Details on test material:
- - Name of test material (as cited in study report): Butylal; Formaldehyddibutylacetal
- Physical state: liquid
- Analytical purity: 98-99 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.04 kg and 2.13 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as saline control.
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no symptoms observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms observed
Any other information on results incl. tables
Findings animal1/animal2:
| Time | Opacity | Iritis | Erythema | Chemosis | |||||||
| 1h | 1/1 | 0/0 | 2/2 | 0/0 | |||||||
| 24h | 1/1 | 0/0 | 1/1 | 0/0 | |||||||
| 48h | 0/0 | 0/0 | 0/0 | 0/0 | |||||||
| 72h | x | x | x | x | |||||||
| 8d | 0/0 | 0/0 | 0/0 | 0/0 |
x: reading is missing.
Mean values over 24h, 48h (72h reading is missing):
Animal1: Opacity: 0.3; Iritis: 0; Erythema: 0.3; Chemosis: 0;
Animal2: Opacity: 0.3; Iritis: 0; Erythema: 0.3; Chemosis: 0;
The application of the test substance caused slight to moderate erythema and slight corneal opacity in the first 24 h. 48 h post application the symptoms were reversible.
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Applicant's summary and conclusion
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