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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-10-16 to 2008-11-18
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
, 2001- 12-17
GLP compliance:
yes (incl. QA statement)
signed 2007-10-15
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Molecular formula:
A: C25H50O2 B: C27H54O2
Details on test material:
- Name of test material (as cited in study report): Sym08/181598
- Synonym: SymMollient S
- Molecular formula: A: C25H50O2; B: C27H54O2
- Molecular weight: A: 382.68 g/mol; B: 410.73 g/mol
- Physical state: Colourless liquid to solid
- Storage condition of test material: Ambient temperature (10 - 30 °C), dark, dry, in original container
No further information on the test material was stated.

Test animals

Crj: CD(SD)
Details on test animals or test system and environmental conditions:
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: Eight to twelve weeks of age
- Weight at study initiation: Body weight range: 171 g - 204 g
- Fasting period before study: Overnight fast immediatley before dosing and for approximately three to four hours after dosing.
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (ad libitum): 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (ad libitum): Mains drinking water
- Acclimation period: At least five days
The animals were provided with environmental enrichment items which were considered not to obtain any contaminant of a level that might have affected the purpose or integrity of the study.

- Temperature: 19 °C - 25 °C
- Relative humidity: 30 to 70 %
- Air exchanges: At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
(in main study)
Details on oral exposure:
In the absence of data regarding the toxicity of the test material, 300 mg/kg was chosen as the starting dose. A single animal was dosed (Concentration: 30 mg/ml; Dose volume: 10 ml/kg). In the absence of mortality at a dose of 300 mg/kg, an additional animal was treated as follows: Dose level 2000 mg/kg ; Dose volume: 2.34 ml/kg. In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of four animals was treated as follows: Dose level: 2000 mg/kg; Dose volume: 2.34 ml/kg. A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
The volume administered to each animal was calculated according to the fasted body weight at the time of dosing.

DOSAGE PREPARATION: For the purpose of the 2000 mg/kg dose level the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg dose level the test material was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
No further information on the oral exposure was stated.
300 mg/kg (Sighting study)
2000 mg/kg (Sighting study / Main test)
No. of animals per sex per dose:
300 mg/kg: one female rat (Sighting study)
2000 mg/kg: five female rats (Sighting study / Main test)
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissue were retained.
No further information on the study design was stated.
An estimate of the acute oral median lethal dose (LD50) of the test material was made.

Results and discussion

Preliminary study:
300 mg/kg: There was no mortality. Signs of systemic toxicity noted were ataxia, hunched posture, pilo erection and tiptoe gait. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Based on the results at a dose level of 300 mg/kg, a dose level of 2000 mg/kg body weight was investigated in a limit test.
Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
2000 mg/kg: There were no deaths.
Clinical signs:
other: 2000 mg/kg: No signs of systemic toxicity were noted during the observation period.
Gross pathology:
2000 mg/kg: No abnormalities were noted at necrospy.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The acute oral median lethak dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg body weight.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic by the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic by the oral route.