Registration Dossier
Registration Dossier
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EC number: 266-945-8 | CAS number: 67701-27-3 This substance is identified by SDA Substance Name: C14-C18 trialkyl glyceride and SDA Reporting Number: 17-001-00.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 25th, 1988 - May 28th, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Purity of test substance not given.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C12-18
- EC Number:
- 266-944-2
- EC Name:
- Glycerides, C12-18
- Cas Number:
- 67701-26-2
- IUPAC Name:
- 67701-26-2
- Reference substance name:
- C12-C18 trialkyl glyceride
- IUPAC Name:
- C12-C18 trialkyl glyceride
- Details on test material:
- - Name of test material (as cited in study report): C10-18 TRIGLYCERIDE
- Name of test material: Hydrogenated Coco-Glycerides
- Physical state: white, waxy solid
- Analytical purity: no data
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
- Date of arrival 23 March 1988
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.24 - 2.64 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 20
- Humidity (%): 68 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
The test material was warmed to approx. 40 ºC and applied as a liquid to the skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank area
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, surgical adhesive tap, elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
After exposure period of 4 h any residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of
- 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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