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Registration Dossier
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EC number: 204-800-2 | CAS number: 126-73-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP defined.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- publication
- Title:
- Acute Toxicologic Evaluation of Tri-n-butylphosphate
- Author:
- Bomhard E, Pauluhn J, Ruf J
- Year:
- 2 000
- Bibliographic source:
- Int J Toxicol 19, 338
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tributyl phosphate
- EC Number:
- 204-800-2
- EC Name:
- Tributyl phosphate
- Cas Number:
- 126-73-8
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- tributyl phosphate
- Details on test material:
- Purity: 99,80 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 2
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The test animals served also as control ( the other eye was not treated)
- Amount / concentration applied:
- 100 µl
- Duration of treatment / exposure:
- single application; the eye lids were hold together for 1 second; the eye was rinsed with saline 24 h after treatment
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3 female rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- 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:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- slightly irritating to the eyes
Any other information on results incl. tables
Irritation in eye:
| Animal Nr., sex (body weight) | examined organ | Symptoms | DRAIZE-Grade after | Irritation Value | ||||||
| 1h* | 24h | 48h | 72h | 7d | 14d | 21d | ||||
| E14, female (3,1 kg) | opacity of cornea | 1 | 1 | 1 | 0 | 0 | 0 | - | 0,7 | |
| cornea area | 2 | 1 | 1 | 0 | 0 | 0 | - | |||
| iris | 1 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| conjunctivae | R | 2 | 2 | 1 | 0 | 0 | 0 | - | 1,0 | |
| S | 2 | 1 | 0 | 0 | 0 | 0 | - | 0,3 | ||
| T | 2 | 0 | 0 | 0 | 0 | 0 | - | |||
| E15, female (3,5 kg) | opacity of cornea | 1 | 1 | 1 | 1 | 0 | 0 | - | 1,0 | |
| cornea area | 3 | 3 | 3 | 3 | 0 | 0 | - | |||
| iris | 1 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| conjunctivae | R | 2 | 2 | 2 | 2 | 1 | 0 | - | 2,0 | |
| S | 3 | 2 | 1 | 1 | 1 | 0 | - | 1,3 | ||
| T | 2 | 1 | 0 | 0 | 0 | 0 | - | |||
| E17, female (3,1 kg) | opacity of cornea | 0 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | |
| cornea area | 0 | 0 | 0 | 0 | 0 | 0 | - | |||
| iris | 0 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| conjunctivae | R | 2 | 2 | 1 | 0 | 0 | 0 | - | 1,0 | |
| S | 2 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| T | 1 | 0 | 0 | 0 | 0 | 0 | - | |||
*= only the values after 24h were taken in consideration!
R = reddening
S = swelling
- = not examined
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- slightly irritating
- Executive summary:
The test substance was tested in a 24 h eye irritation test in rabbits.
The test substance (100 µl) was administered into one eye of 3 rabbits (the other eye remained untreated and served as control). The substance was washed out after 24 hours with NaCl.
The animals were observed for 21 days after experiment.
The test substance was found to be slightly irritating to eye.
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