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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:
Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized
EC Number:
605-143-8
Cas Number:
158318-67-3
Molecular formula:
Unspecified (UVCB)
IUPAC Name:
Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized
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:
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 study day 3. In three of these animals and the fifth animal very slight erythema was noted on study day 3. Slight edema (grade 2) was noted in all male animals on study day 2 and decreased to very slight edema (grade 1) on study day 3 after application. On study day 3 scaling was noted in all male animals, which persisted in one animal up to study day 6. Incrustations were observed in one animal from study day 3 until study day 6 and in one further animal on study day 6 only.
In all female animals very slight erythema (grade 1), noted on study day 1, increased to well-defined erythema (grade 2) on study day 2 and persisted in three animals until study day 3. In the two other animals very slight erythema was noted on study day 3. Very slight edema (grade 1) was noted in four female animals on study day 2 and 3. In one animal slight edema (grade 2) was observed on study day 2 which decreased to very slight edema on study day 1. Scaling was noted in four females on study day 3 and persisted in two animals until study day 6. In one animal incrustations were noted on study day 2 and 3.
Body weight:
The mean body weight of the animals increased throughout the study period within the normal range. Two females showed stagnation of body weight during the first postexposure week, but gained weight in a normal range during the second 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

Interpretation of results:
GHS criteria not met