Registration Dossier
Registration Dossier
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EC number: 293-170-2 | CAS number: 91052-13-0
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:
- March 6th, 2000 - March 10th, 2000
- 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:
- 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:
- , lack of details on test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C14-18 mono- and di-
- EC Number:
- 266-952-6
- EC Name:
- Glycerides, C14-18 mono- and di-
- Cas Number:
- 67701-33-1
- IUPAC Name:
- 67701-33-1
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white pellets
- Analytical purity: not reported
- Lot/batch No.: 00010271
- Expiration date of the lot/batch: 10 years
- Storage condition of test material: amient 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 (76410 Saint-Aubin-Les-Elbeuf, France).
- Age at study initiation: not reported
- Weight at study initiation: 1.8 kg and more
- Housing:individually in stainless steel cages on floor grid
- Diet (e.g. ad libitum): Ergilap Anco, COFNA, France.
- Water (e.g. ad libitum): tap water, periodically analyzed chemicophysically and bacteriologically
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: 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
VEHICLE
The crunched test substance (fine powder) was applied soaked with mineral oil (Sigma batch 116 H 1202)
- Amount(s) applied (volume or weight with unit): 0.25 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Readings at 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal trunk
- % coverage: 2.5 cm x 2.5 cm gauze patch
- Type of wrap if used: Micropore tape of 5 cm x 5 cm, extensible bandage (type of varicose vein bandage) fixed with Micropore
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool with water
- Time after start of exposure: 4h
SCORING SYSTEM:
Draize system
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: 48 h
- 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:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals and 3 reading timepoints
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- 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 at any timepoint and in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information and not classified according to EU classification criteria Criteria used for interpretation of results: EU
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