Registration Dossier

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:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 402.
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay Labor für biologische Analytik GmbH, 69120 Heidelberg
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Soybean oil, epoxidized, reaction products with methanol
- Physical state: Liquid / yellow
- Test item No.: 12/0114-1
- Homogeneity: The test item was homogeneous by visual inspection.
- Expiration date of the lot/batch: December 2013
- Storage Stability: The stability of the test item under storage conditions over the test period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature.
- Lot/batch No.: CE61910022
- Composition of test material, percentage of components: 0.123 area-% tridecanoic acid, 0.146 area-% tetradecanoic acid, 22.456 area-% hexadecanoic acid, 0.176 area-% heptadecanoic acid methyl ester, 6.878 area-% octadecanoic acid, 0.748 area-% eicosanoic acid. Determined by GC-analysis (for details see analytical report No.: 12L00136).

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 9 weeks, female animals approx. 13 weeks
- Weight at study initiation: Male: 256-268 gram, Female: 212-231 gram. Animals of comparable weight (± 20% of the mean weight)
- Housing: Single housing in Makrolon cage, type III. As bedding material H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany) was used and for enrichment NGM E-022; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria.
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Clipping of the fur: About 24 hours before administration
- Route of application: Single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk); covering of the application site with a semi-occlusive dressing for 24 hours. The test item was covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG). Afterwards removal of the semi-occlusive dressing, rinsing of the application site with warm water.
- Area of exposure: About 40 cm² (corresponds to at least 10% of the body surface)
- Time of day of application: In the morning

TEST MATERIAL
- Amount(s) applied: 4.97 mL/kg bw

Duration of exposure:
14 days
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
- Frequency of observations and weighing: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animals was made at least once each workday, these records are archived by Bioassay. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes. Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination. Furthermore, no local effects were observed.
Body weight:
The mean body weight of the animals increased throughout the study period within the normal range, with the exception of one male and one female, which showed stagnation of body weight during the second post-exposure week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion