Registration Dossier
Registration Dossier
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EC number: 200-312-9 | CAS number: 57-10-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Jan - 04 Feb 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- application under occlusion; 4 animals used
- GLP compliance:
- yes
Test material
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Details on test material:
- - Name of test material (as cited in study report): Edenor C16
- Physical state: white powder
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach/D.
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, 7343, Kuchen, D
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, 4902 Bad Salzuflen; ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): ca. 45 - 50
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days; since no scores could be observed within 3 days the experiment was cancelled due to animal welfare reasons; therefore the short observation period of 3 days does not represent a deviation to the OECD guideline)
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: ~2.5 x 2.5 cm
- Type of wrap if used: plastic foil with adhesive plasters and an acrylastic band aid
SCORING SYSTEM: Skin irritation/corrosion was evaluated according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, 2, 3, 4
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: #1, 2, 3, 4
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- No skin reactions were observed.
- Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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