Registration Dossier
Registration Dossier
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EC number: 221-201-1 | CAS number: 3030-47-5
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:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, application amount)
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-dimethylaminoethyl)(methyl)amine
- EC Number:
- 221-201-1
- EC Name:
- Bis(2-dimethylaminoethyl)(methyl)amine
- Cas Number:
- 3030-47-5
- Molecular formula:
- C9H23N3
- IUPAC Name:
- (2-{[2-(dimethylamino)ethyl](methyl)amino}ethyl)dimethylamine
- Details on test material:
- - Name of test substance (as cited in study report): Pentamethyl-diaethylen-trieamin
- Analytical purity: no data
- Physical state: liquid
- Density: 0.829 g/cm³
- Substance number: XXIII/80
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- - Source: Gaukler
- Weight at study initiation: 3.37 kg (female), 3.32 kg (male)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent eye served as control
- Amount / concentration applied:
- 50 mm³ of the undiluted test substance
- Duration of treatment / exposure:
- single application without rinsing
- Observation period (in vivo):
- 8 days (reading after end of treatment at 10 min, 1h, 3 h, 24 h, 48 h, 72 h, 4 d, 7 d and 8 d)
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
Any other information on results incl. tables
Reading |
Animal 1 |
Animal 2 |
||||||||
Cornea |
Iris |
Conj |
Chem |
Remarks |
Cornea |
Iris |
Conj |
Chem |
Remarks |
|
10 min |
2 |
|
|
|
NMr, NP, S |
1 |
|
|
|
NMw, NP, S |
1 h |
2 |
|
|
1 |
NMr, BS |
2 |
|
|
1 |
NMw, BS |
3 h |
2 |
|
|
2 |
NMg, BS |
3 |
|
|
2 |
NMr, BS |
24 h |
3 |
|
2 |
2 |
NMg, CE |
3 |
|
2 |
4 |
Su, CE |
48 h |
3 |
|
|
2 |
NMg, S, N |
3 |
|
2 |
2 |
NMw, Su, CE |
72 h |
3 |
|
|
4 |
NMg, Su, CE |
3 |
|
|
4 |
NMg, Su, CE |
4 d |
3 |
|
|
4 |
N |
3 |
|
|
2 |
NMr, CE, Su |
7 d |
3 |
|
|
2 |
NMg, Su, CE |
3 |
|
|
2 |
NMr, Su, CE |
8 d |
3 |
|
|
2 |
N |
3 |
|
|
2 |
NMr, Su, CE |
Conj.: Conjunctivae Score
Chem: Chemosis Score
NMr: nictitating membrane red-brown; NMg: nictitating membrane grey; NMw: nictitating membrane white; NP: narrowed pupil; S: secretion; BS: bloody secretion
CE: crusted eyelids; N: necrotic eyelids; Su: suppuration
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information
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