Registration Dossier
Registration Dossier
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EC number: 500-041-9 | CAS number: 25723-16-4 1 - 6.5 moles propoxylated
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
Test material
- Reference substance name:
- Propylidynetrimethanol, propoxylated
- EC Number:
- 500-041-9
- EC Name:
- Propylidynetrimethanol, propoxylated
- Cas Number:
- 25723-16-4
- Molecular formula:
- C3H5(CH2OR)3 R= (C2H3(CH3)O)nH sum of n: >1 - <6.5 mol PO
- IUPAC Name:
- Propylidynetrimethanol, propoxylated
- Details on test material:
- Propylidenetrimethanol, propoxylated mw 310; clear, colourless, viscous liquid; purity not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Cheshire, UK.
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2000 - 3500 g
- Housing: Suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye was used as control
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- 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
- 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Dulling of the normal lustre of the cornea was noted in one treated eye 1 h after treatment. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 h after treatment. Iridial inflammation was noted in all treated eyes 1 and 24 h after treatment. Moderate conjunctival irritation was noted in all treated eyes 1, 24 and 48 h after treatment with minimal conjunctival irritation noted 72 h after treatment. Moderate to minimal swelling (chemosis) was found at the 1, 24 and 48 h reading in all animals.
Any other information on results incl. tables
AVERAGE SCORE (24,48,72 hours) per animal 1 / 2 / 3
- Cornea: 0.0 / 0.3 / 0.3
- Iris: 0.3 / 0.3 / 0.3
- Conjunctivae (Redness): 1.7 / 1.7 / 1.7
- Conjunctivae (Chemosis): 0.7 / 1.0 / 1.0
All treated eyes appeared normal after 7 days.
Additional data supporting the information is attached below under 'Attached background material'.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Propylidentrimethanol, propoxylated resulted in only slight irritation of the skin of rabbit, which was fully reversible within 7 days.
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