Registration Dossier
Registration Dossier
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EC number: 248-329-0 | CAS number: 27214-38-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 10 Mar 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No details on analytical purity of the substance.
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:
- yes
- Remarks:
- no details on analytical purity of the substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerol monomyristate
- EC Number:
- 248-329-0
- EC Name:
- Glycerol monomyristate
- Cas Number:
- 27214-38-6
- Molecular formula:
- C17H34O4
- IUPAC Name:
- 2-hydroxy-1-(hydroxymethyl)ethyl myristate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white pellets
- Analytical purity: no data
- Lot/batch No.: 00010271
- Expiration date of the lot/batch: 10 years
- Storage condition of test material: ambient temperature and out of light
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 Supplier, Saint-Aubin-Les-Elbeuf, France
- Age at study initiation: not reported
- Weight at study initiation: > 1.8 kg
- Housing: individually in stainless steel cages on floor grid
- Diet: pellets (Ergilap Anco, COFNA, France), ad libitum
- Water: tap water (periodically analysed chemicophysically and bacteriologically), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g, ground to a fine dust using a pestle in a mortar - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein after 24 h observation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Slight to moderate redness of conjunctivae occurred in all three tested animals, which was fully reversible within 72 h. At the 1 h reading time point, slight chemosis was observed in all animals, and persisted in 2 of 3 tested animals up to 24 h after test substance instillation. However, chemosis was fully reversible within 48 h in all animals.
- Other effects:
- During the 72-h observation period, no clinical signs of toxicity were noted in the treated animals.
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:
- CLP: not classified
DSD: not classified
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