Registration Dossier
Registration Dossier
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EC number: 243-573-4 | CAS number: 20193-20-8
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Draize Test (Federal Register 38, No. 187 § 1500.42 (eye), p. 27019, 23.09.1973):
0.10 mL of the test substance were applied to the conjunctival sac of one eye in each of 6 rabbits. The animals were observed after 1, 24, 48 and 72 h and 7 d after installation. The eyes were not washed out. - GLP compliance:
- no
Test material
- Reference substance name:
- N-ethylpropylamine
- EC Number:
- 243-573-4
- EC Name:
- N-ethylpropylamine
- Cas Number:
- 20193-20-8
- Molecular formula:
- C5H13N
- IUPAC Name:
- N-ethylpropan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Aethylpropylamin
- Physical state: liquid
- Analytical purity: 99 %
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 - 4 kg
- Housing: individually
- Diet: standard pellet feed for rabbits ad libitum
- Water: ad libitum
- Acclimation period: > 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- see Observation period (no washing conducted)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-6)
- Time point:
- 24/48/72 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- (within 7 days)
- Remarks on result:
- other: 5 animals with a corneal opacity score of 4 at the end of the observation period;
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1 - 6)
- Time point:
- 24/48/72 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h (7 days after instillation: no data)
- Remarks on result:
- other: 7 days post application: purulent conjunctivae, in part necrotic with nasty smell; no chemosis score could be therefore determined on day 7;
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1 - 6)
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h (7days after instillation: no data)
- Remarks on result:
- other: 7 days post application: purulent conjunctivae, in part necrotic with nasty smell; no iritis score could be therefore determined on day 7;
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1 - 6)
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Due to substance staining assessment not possible for animal 1, 3, 5, 6, 24 and 48 h after instillation. The mean was only calculated for the available scores.
- Irritant / corrosive response data:
- The application of the test substance led initially to defense movement, pain cries and tightly shutting of the eyes. 24 h post application the eye was agglutinated by purulence and purulent discharge was noted. 7 days post application purulent conjunctivae, in part necrotic with nasty smell; 5 animals still showed corneal opacity score 4.
Any other information on results incl. tables
Findings:
animal 1/2/3/4/5/6
| Time | Opacity | Iritis | Erythema | Chemosis | Secretion | |||
| 24 h | 4/2/4/2/4/4 | 2/0/2/0/2/2 | #/2/#/2/#/# | 3/4/3/2/2/2 | 0/2/2/2/1/2 | |||
| 48 h | 4/2/4/2/4/4 | 2/0/2/0/2/2 | #/2/#/2/#/# | 4/4/4/3/4/4 | 1/2/2/2/3/3 | |||
| 72 h | 4/3/4/3/4/4 | 2/2/2/1/2/2 | 0/2/0/1/0/0 | 4/4/4/3/4/4 | 2/2/2/2/2/2 |
#: due to substance staining assessment not possible.
Irritation Index >/= 88.3 (max. 110)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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