Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

of 30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Deviations:

no

Test guideline 4

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

Test material information

Constituent 1

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