Registration Dossier
Registration Dossier
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EC number: 203-818-8 | CAS number: 110-95-2
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 on test substance and test animals)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (application amount, limited documentation, 2 animals)
- Principles of method if other than guideline:
- 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 h 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.
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N,N',N'-tetramethyltrimethylenediamine
- EC Number:
- 203-818-8
- EC Name:
- N,N,N',N'-tetramethyltrimethylenediamine
- Cas Number:
- 110-95-2
- Molecular formula:
- C7H18N2
- IUPAC Name:
- N,N,N',N'-tetramethyltrimethylenediamine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Tetramethyl-propylendiamin
- Analytical purity: no data
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.03 kg and 3.24 kg (males)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as saline control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- Single application, no rinsing
- Observation period (in vivo):
- 8 days
- 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:
- animal #1
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis 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:
- chemosis 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:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: conjunctivae score of 2 in animal#2 on day 8.
- Irritant / corrosive response data:
- 1 h post application: nictitating membrane and mucosae reddish-brown, discharge of blood.
24 h post application: nictitating membrane grey, mucosae reddish-brown, margins of eyelid necrotic.
8 days post application: nictitating membrane grey, mucosae grey, margins of eyelid necrotic, beginning staphyloma.
Any other information on results incl. tables
Findings animal1:
Time |
Opacity |
Chemosis |
Erythema |
Iris |
1h |
3 |
3 |
0 |
0 |
24h |
3 |
3 |
0 |
0 |
48h |
3 |
3 |
0 |
0 |
72h |
3 |
3 |
0 |
2 |
8d |
3 |
3 |
0 |
2 |
Findings animal2:
Time |
Opacity |
Chemosis |
Erythema |
Iris |
1h |
3 |
3 |
0 |
0 |
24h |
3 |
3 |
0 |
0 |
48h |
3 |
3 |
0 |
0 |
72h |
3 |
3 |
0 |
0 |
8d |
3 |
3 |
2 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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