Registration Dossier
Registration Dossier
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EC number: 286-490-9 | CAS number: 85251-77-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 11th, 1999 - March 11th, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono- and di-
- EC Number:
- 286-490-9
- EC Name:
- Glycerides, C16-18 mono- and di-
- Cas Number:
- 85251-77-0
- Molecular formula:
- C19H38O4; C21H42O4; C35H68O5; C39H76O5
- IUPAC Name:
- Glycerides, C16-18 mono- and di-
- Details on test material:
- - Name of test material (as cited in study report): Glyceryl Palmitostearate
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: August 1st, 2000
- pH = 5.8
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.23 - 2.40 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet (e.g. ad libitum): pelleted complete rabbit diet 112 C-10, Usine d'Alimentation Rationnelle, France.
- Water (e.g. ad libitum): softened and filtered mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/-3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: sterile Codex liquid paraffin
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g prepared as a paste with 0.21 g of sterile Codex liquid paraffin.
The paste was administered within 4 hours of preparation.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.21 g sterile Codex liquid paraffin
- Lot/batch no. (if required): T0122B
- Expiry date: December 1st, 1999 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage: 2.5 cm x 2.5 cm (about 6 cm2) gauze pad, perforated tape
- Type of wrap if used: crimped gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water was used to remove the excess of test article
- Time after start of exposure: 4 hourse
SCORING SYSTEM:
Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean of 3 readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- No mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information to rabbit skin Criteria used for interpretation of results: EU
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