Registration Dossier
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EC number: 947-398-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-03-18 to 1996-03-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glyceryl Citrate/Lactate/Linoleate/Oleate
- IUPAC Name:
- Glyceryl Citrate/Lactate/Linoleate/Oleate
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts
- EC Number:
- 294-585-1
- EC Name:
- Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts
- Cas Number:
- 91744-23-9
- IUPAC Name:
- 91744-23-9
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Physical state: liquid
- Stability under test conditions: > 1 year
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 2.8 - 3.8 kg
- Housing: Conventional, singly in stainless steel cages
- Diet: Ssniff K4 - Complete feed for rabbits, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: Drinking water, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany, ad libitum
- Acclimation period: At least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 15 per hour
- Photoperiod: 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 cm³ - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: With warm physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD Guideline 405
TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 24 hours after administration
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Marked hyperaemias of some blood vessels in all animals one hour after application, after 24 hours no effects was noticed.
Any other information on results incl. tables
Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0 |
0 |
Area effected |
- |
- |
- |
- |
Maximum average score (including area affected, max 110) |
0 |
0 |
0 |
0 |
Reversibility*) |
- |
- |
- |
- |
Average time (unit) for reversion |
- |
- |
- |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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