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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-07-16 to 2012-09-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
of 30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay Labor für biologische Analytik GmbH 69120 Heidelberg
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 8-(3-octyloxiran-2-yl)octanoate; methyl 8-[3-({3-[(3-ethyloxiran-2-yl)methyl]oxiran-2-yl}methyl)oxiran-2-yl]octanoate; methyl 8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoate
EC Number:
605-143-8
Cas Number:
158318-67-3
Molecular formula:
Unspecified (UVCB)
IUPAC Name:
methyl 8-(3-octyloxiran-2-yl)octanoate; methyl 8-[3-({3-[(3-ethyloxiran-2-yl)methyl]oxiran-2-yl}methyl)oxiran-2-yl]octanoate; methyl 8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoate
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material: Sovermol 1055
- Substance type: organic
- Physical state: Liquid / colourless, clear
- Analytical purity: The test item is a mixture of several single compounds. The composition of the substance was verified by GC analysis
- Lot/batch No.: CE80580015
- Expiration date of the lot/batch: February 27, 2013
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: The test item was stable under storage conditions.
- Storage condition of test material: Room temperature
- The CAS RN cited in the test report is 91051-90-0 (chemical name: Fatty acids, tallow, Me esters, epoxidized). However, after the finalization of the study, it became evident that the test material is better described by CAS RN 158318-67-3 (Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized).

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: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: male mean weight: 239.0 g ± 7.31 g; female mean weight: 205.6 g ± 7.16 g
- Fasting period before study:
- Housing: Makrolon cage, type III
- 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): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used: 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)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2.20 mL/kg bw
- Concentration: undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: 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 atleast once each workday. 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.
Statistics:
Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No systemic clinical signs were observed during clinical examination. In four male animals very slight erythema (grade 1), noted on study day 1, increased to well-defined erythema (grade 2) on study day 2 in all animals and persisted in one animal until s
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

Interpretation of results:
GHS criteria not met