Registration Dossier
Registration Dossier
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EC number: 293-170-2 | CAS number: 91052-13-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- May 7th, 1990 - May 10th, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study with acceptable restrictions Lack of details on test substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , lack of details on test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- EC Number:
- 294-574-1
- EC Name:
- Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- Cas Number:
- 91744-13-7
- IUPAC Name:
- 91744-13-7
- Details on test material:
- - Name of test material (as cited in study report): Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- Physical state: brownish liquid
- Analytical purity: no data
- Lot/batch No.: 0189-0-040
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany.
- Age at study initiation: 21 - 24 months
- Weight at study initiation: approx. 2560 g
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2023, Lage, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with handwarm water
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 treated animals and mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 treated animals and mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 treated animals and mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 treated animals and mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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