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Registration Dossier
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EC number: 201-122-9 | CAS number: 78-51-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2 May 2000 to 4 july 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-butoxyethyl) phosphate
- EC Number:
- 201-122-9
- EC Name:
- Tris(2-butoxyethyl) phosphate
- Cas Number:
- 78-51-3
- Molecular formula:
- C18H39O7P
- IUPAC Name:
- tris(2-butoxyethyl) phosphate
- Details on test material:
- - Name of test material (as cited in study report): Hostaphat B 310 roh (Tributoxyethylphosphate, TBEP)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg
- Age at study initiation: no data
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- Clear colourless discharge was observed in all animals, persisting to 48 hours in one animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TBEP was found to be slightly irritating to New Zealand White rabbits. Under the conditions of this study, TBEP would not be classified for eye irritation according to the criteria of Annex VI Directive 67/748/EEC or EU GHS.
- Executive summary:
Twenty four hours before the start of the study, the test eyes of all animals were examined for corneal lesions under UV light. Only animals without ocular lesions were used in the study. Undiluted TBEP (0.1 ml) was administered once to the conjunctival sac of the left eye of three rabbits. The untreated right eyes served as controls. 24 hours after administration, the treated eyes were washed with warm isotonic saline. The eyes were examined at 1, 24, 48 and 72 hours. At 24, 72 hours and 7 days, eyes were also examined for corneal lesions under UV light. Lesions in cornea, iris or conjunctiva were scored numerically.
One hour up to 72 hours, the treated conjunctivae showed beefy-red blood vessels and slight to moderate swelling. From 24 to 48 hours, the iris of one animal was reddened. Diffuse translucent areas of the cornea were observed one hour after administration in two animals, persisting to72 hours in one animal. Clear colourless discharge was observed in all animals, persisting to 48 hours in one animal. All signs of irritation had resolved at 7 days.
Under the conditions of this study, TBEP was considered not irritating to eyes..
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