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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:
No systemic clinical signs were observed during clinical examination
Body weight:
The mean body weight of the:
- male animals increased throughout the study period within the normal range.
- female animals did not change significantly, during the first post-exposure observation week. The reason is that female animals have already reached the phase of slow growth when they are used for the experiment at the required age range
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