Registration Dossier
Registration Dossier
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EC number: 217-461-0 | CAS number: 1860-26-0
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- study protocol is in principle similar to OECD TG 405, with acceptable restrictions (only 50 µL instilled, only 2 animals used, observation period only 8 days)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 50 µL instilled, only 2 animals used, observation period only 8 days.
- 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 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. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
- EC Number:
- 217-461-0
- EC Name:
- 2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
- Cas Number:
- 1860-26-0
- Molecular formula:
- C24H51N
- IUPAC Name:
- tris(2-ethylhexyl)amine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tri-2-Aethylhexylamin
- Physical state: liquid
- Analytical purity: approx. 98%
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: 3.06 and 3.19 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Table 1: Eye irritation parameter observed in two treated animals
| Exposure time | Opacity | Iritis | Erythema | Chemosis | ||||
| animal 1 | animal 2 | animal 1 | animal 2 | animal 1 | animal 2 | animal 1 | animal 2 | |
| 1 h | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| 24 h | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| 48 h | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| 72 h | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| 8 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mean value over 24/48/72 h | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After exposure times of 25, 48 and 72 h the application of the test material caused slight reversible erythema to the eyes of the exposed animals.
At the end of the observation period of 8 days all effects were reversible.
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