Registration Dossier
Registration Dossier
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EC number: 248-329-0 | CAS number: 27214-38-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: mineral oil
- Controls:
- other: vehicle alone on different site of the treated animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g soaked with 0.25 mL mineral oil
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 mL
- Lot/batch no.: Sigma batch 116 H 1202 - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of the dorsal area of the trunk
- Type of wrap if used: the gauze patch was put on a Micropore tape of 5 cm x 5 cm and the semi-occlusive dressing was held in place with an extensible bandage (type of varicose vein bandage) fixed with Micropore.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed using a cotton wool with water or an appropriate solvent.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight erythema was observed in 2 of 3 animals 24 and 48 h after patch removal, which was fully reversible within 48 and 72 h, respectively. In the third animal no erythema was observed. No oedema occurred in any of the tested animals and no skin reactions were observed on the control sites of the animals treated with the vehicle alone.
- Other effects:
- All animals showed the expected increase in body weight. No clinical signs of toxicity were observed.
Any other information on results incl. tables
The vehicle alone caused no skin reactions in any of the animals at any reading timepoint.
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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