Registration Dossier
Registration Dossier
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EC number: 203-312-7 | CAS number: 105-59-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-methyliminodiethanol
- EC Number:
- 203-312-7
- EC Name:
- 2,2'-methyliminodiethanol
- Cas Number:
- 105-59-9
- Molecular formula:
- C5H13NO2
- IUPAC Name:
- 2-[(2-hydroxyethyl)(methyl)amino]ethan-1-ol
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: 2.5 kg (mean)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as control treated with 0.9 % NaCl (saline).
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- single application - eyes were not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Irritant / corrosive response data:
- In the rabbit eye, 50 μL undiluted methyldiethanolamine caused redness, swelling and clouding of the cornea as well as conjunctival bleeding. The symptoms had disappeared after 8 days.
Any other information on results incl. tables
Table 1: Findings animal1/animal2:
| Time | Conjunctiva | ||||
Opacity |
Iritis |
Erythema |
Chemosis |
||
1 h |
3/3 |
0/0 |
2/2 |
2/2 |
|
24 h |
1/1 |
0/0 |
2/2 |
1/1 |
|
48 h |
1/1 |
0/0 |
2/2 |
1/1 |
|
72 h |
1/1 |
0/0 |
1/1 |
0/0 |
|
8 days |
0/0 |
0/0 |
0/0 |
0/0 |
|
Mean values over 24, 48, and 72 h:
Animal1: Opacity: 1; Iritis: 0; Erythema: 1.7; Chemosis: 0.7
Animal2: Opacity: 1; Iritis: 0; Erythema: 1.7; Chemosis: 0.7
In the rabbit eye, 50 μL undiluted methyldiethanolamine caused redness, swelling and clouding of the cornea as well as conjunctival bleeding. The symptoms had disappeared after 8 days.
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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