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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
EC Number:
239-032-7
EC Name:
Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
Cas Number:
14960-06-6
Molecular formula:
C18H35NO4.Na
IUPAC Name:
sodium 3-[(2-carboxyethyl)(dodecyl)amino]propanoate
Specific details on test material used for the study:
- Name of test material (as cited in study report): DERIPHAT 160 C
- Physical state:Solid, white
- Analytical purity: 97% The test substance was characterized analytically (for details see the analytical report; project no.: AU 122958-1)
- Lot/batch No.:4986V1
- Expiration date of the lot/batch: until 03 Jun 2014

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation:203-236g
- Housing:Makrolon cage, type III
- Diet & water: ad libitum
- Acclimation period: At least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure:40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used: semi-occlusive dressing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: suspension in olive oil

VEHICLE (olive oil)
- Amount(s) applied (volume or weight with unit): 20 mL/kg bw (substance in vehicle)
- Concentration (if solution): 25 g/100 mL (concentration of substance in olive oil)
Duration of exposure:
24h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1) and several times (see results) until the last day of observation
- Mortality: Check for any dead or moribund animals at least once each workday
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period
Statistics:
common statistics

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No systemic clinical signs were observed during clinical examination
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Other findings:
Skin effects:
Very slight erythema (grade 1) at the application site was observed in all male animals, during study day 1 and 2.
Very slight erythema (grade 1) at the application site was observed in four out of five female animals during study day 1 until day 2
One female animal revealed very slight erythema (grade 1) during study day 1 and day 2, well-defined erythema (grade 2) during study day 2 and day 3 and scaling on day 6.
Scaling was observed in 2 more female animals, of which one also revealed incrustations,during study day 6.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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