Registration Dossier
Registration Dossier
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EC number: 701-361-3 | CAS number: -
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:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylic acid (<6.5 mol EO and <6.5 mol PO)
- EC Number:
- 701-361-3
- Molecular formula:
- C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x . x C3 H4 O2
- IUPAC Name:
- Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylic acid (<6.5 mol EO and <6.5 mol PO)
Constituent 1
- Specific details on test material used for the study:
- Batch no. 7/85, 8.7.85
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach/Main
- Age at study initiation: not mentioned
- Weight at study initiation: male: 3.08 kg (mean of two animals); female: 2.94
- Housing: single housing
- Diet: Kliba 341, 4 mm, Klingentalmuehle AG, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- No washing performed.
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3 (two males, one female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing performed
OBSERVATIONS: Examination and scoring were performed after 1 hr, 24 hrs, 48 hrs, 72 hrs after instillation of the eye with the test substance.
SCORING SYSTEM: according to OECD Guideline 405; Calculation of the mean according to 83/467/EEC Criteria of July 29th, 1983, only the readings of 24, 48 and 72 hrs were used.
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
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- 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:
- iris score
- Basis:
- animal #3
- 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:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- 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
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- After 1 hr conjunctivae redness and chemosis could be detected. But the conjunctivae redness was reversible within 24 hrs (animal 1 and animal 3) or 48 hrs (animal 2), and the chemosis was reversible within 24 hrs.
- Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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