Registration Dossier
Registration Dossier
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EC number: 203-058-7 | CAS number: 102-82-9
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- Tributylamine
- EC Number:
- 203-058-7
- EC Name:
- Tributylamine
- Cas Number:
- 102-82-9
- Molecular formula:
- C12H27N
- IUPAC Name:
- tributylamine
- Details on test material:
- - Name of test material (as cited in study report): Tributylamin
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenach, Germany
- Weight at study initiation: 2.78, 2.66, 2.78 kg
- Housing: single
- Diet: KLIBA 341, 4mm; klingentalmuehle AG, CH, ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single application - eyes were not washed out
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Maximum score is the sum of individual findings for one animal.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Given score is the mean value for all three time points.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Given score is the mean value for all three time points.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Given score is the mean value for all three time points.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Findings animal1/animal2/animal3:
| Time | Conjunctiva | |||||||||||
| Opacity | Iritis | Erythema | Chemosis | |||||||||
| 1 h | 0/0/0 | 0/0/0 | 2/2/2 | 0/0/0 | ||||||||
| 24 h | 0/0/0 | 0/0/0 | 2/1/2 | 0/0/0 | ||||||||
| 48 h | 0/0/0 | 0/0/0 | 1/1/1 | 0/0/0 | ||||||||
72 h |
0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | ||||||||
Mean values over 24, 48, and 72 h:
Animal1:Opacity: 0; Iritis: 0; Erythema: 1; Chemosis: 0
Animal2:Opacity: 0; Iritis: 0; Erythema: 0.7; Chemosis: 0
Animal3:Opacity: 0; Iritis: 0; Erythema: 1; Chemosis: 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test the test item was not irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008.
- Executive summary:
A reliable experimental study was performed with three rabbits (BASF AG, 1985; similar to OECD 405, RL 2, key study). Animals were exposed to 0.1 mL of neat test item and were observed for 72 hours. At the 1, 24, 48 and 72 h reading there were no effects on the cornea, iris and no conjunctivia chemosis was observed (score 0 for all endpoints at all time points). Only a mean conjuctiva redness score of 0.9 (mean of all animals; 24 -48 -72 h) was observed, effects were fully reversible within 72 h, thus the test item is not irritating to the eyes.
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