Registration Dossier
Registration Dossier
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EC number: 266-928-5 | CAS number: 67701-03-5 This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid and SDA Reporting Number: 19-005-00.
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:
- 29 Jan - 04 Feb 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- occlusive dressing; no details on reading time points
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Commission Directive 84/449/EEC
- Deviations:
- yes
- Remarks:
- occlusive dressing; no details on reading time points
- 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:
- hexadecanoic acid
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, Germany
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, Kuchen, Germany
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20 - 21
- Humidity (%): approx. 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:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 4 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: The substance was applied to the intact skin using a patch (2.5x2.5 cm), which was covered by a plastic foil using adhesive plasters and an acrylastic band aid.
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- other: mean over all reading time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- other: mean over all reading time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- no details on reading time points given
- Irritation parameter:
- edema score
- Basis:
- animal:
- Remarks:
- #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- no details on reading time points given
- Irritant / corrosive response data:
- No skin reactions were observed.
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
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