Registration Dossier
Registration Dossier
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EC number: 270-299-2 | CAS number: 68424-38-4 This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid sodium salt and SDA Reporting Number: 19-006-04.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- IUPAC Name:
- palmitic acid
- Reference substance name:
- [TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
- IUPAC Name:
- [TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
- Details on test material:
- no data
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Züchter Fa. Thomae, Biberach, Germany
- Weight at study initiation: mean: 2452.5g
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12712
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 4
- Details on study design:
- The substance Edenor C16 was tested in undiluted form for primary skin irritation. 0.5 g of the product were applied to a 2.5 cm x 2.5 cm linen cloth and evenly distributed on the linen cloth. The linen cloth were placed on the shaved back skin of the rabbits and covered with a large plastic foil, which was fixed at the edges with tape. To achieve a secure fixation and an occlusive cover all was covered with acrylastic band. The duration of treatment was 4 hours and the observation period 3 days.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- 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
- Conclusions:
- No skin reactions were observed.
- Executive summary:
The substance Edenor C16 was tested for its primary skin irritation under occlusive conditions on the shaved back skin of 4 rabbits according the OECD guideline 404.
After a contact time of 4 hours the skin reactions were evaluated.
No skin reactions were observed.
Therefor the substance Edenor C16 is not irritating.
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