Registration Dossier
Registration Dossier
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EC number: 500-110-3 | CAS number: 50586-59-9 1 - 6.5 moles ethoxylated
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:
- other: Study was conducted in accordance to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated
- EC Number:
- 500-110-3
- EC Name:
- Propylidynetrimethanol, ethoxylated
- Cas Number:
- 50586-59-9
- Molecular formula:
- C3H5(CH2O(C2H4O)nH) sum of n: >1 - <6.5 mol EO
- IUPAC Name:
- Propylidynetrimethanol, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report): Polyol TP30
Trimethylolpropane, ethoxylated, molar ratio 1 : 3
clear viscous liquid
purity > 99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Buckmasters, Henham, hertfordshire, England
- Age at study initiation: 12 - 14 weeks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye remained untreated and served as a control
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Observation period (in vivo):
- after 1 hour and 1, 2, 3, 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Not rinsed
SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: Standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 - #3
- Time point:
- other: 1 hour, 1, 2, 3, 4 and 7 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #3
- Time point:
- other: 1 hour and 1, 2, 3, 4 and 7 days
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- > 0 - <= 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- > 0 - <= 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- > 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Conclusions:
- No corneal damage or iridial inflammation was recorded in any of the animals. Mild conjunctival irritation was recorded in all three animals, this had resolved two or three days after instillation. Thus instillation of the test substance into the rabbit eye did notelicit a positive response in any of the three treated animals.
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