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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[bis(2-hydroxyethyl)amino]ethyl oleate
EC Number:
233-621-2
EC Name:
2-[bis(2-hydroxyethyl)amino]ethyl oleate
Cas Number:
10277-04-0
Molecular formula:
C24H47NO4
IUPAC Name:
2-[bis(2-hydroxyethyl)amino]ethyl octadec-9-enoate
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Breeding
- Age at study initiation: approx 7 weeks (males); approx. 8 weeks (females)
- Weight at study initiation: 171 +/- 3 g (males); 169 +/- 4 g (females)
- Fasting period before study: approx 16 hours pre dosing
- Housing:macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour period

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000 mg/kg/bw
No. of animals per sex per dose:
5 male
5 female
Control animals:
no
Details on study design:
The test item (Vehicle: Sesame oil, dose level was 2000 mg/kg/bw) was applicated via gavaging. The observation peroide was 14 days. The occurence of symptomes was recorded twice a day (forenoon and afternoon) during the week. On the week-end and on public holidays the occurence of symtoms was recorded once a day. During this time periode the weight of the animals was recorded once a week.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
male: 0
female: 0
Clinical signs:
other: male: unspecific symptoms, i.e. stilted gait and reduced spontaneous activity occured 30 min - 2 hours after application of the test item female: no toxic symptoms were observed during the whole study period.
Gross pathology:
male and female: no macroscopic effects were observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD 50 of the test item is >2000 kg/mg/bw.
Executive summary:

The acute oral toxicity of the test item was investigated in 5male and 5 female Wistar rats using sesame oil as vehicle. The study was performed according to OECD test guideline 401 and followed the principles of GLP. The animals were administered the test compound by single-dose gavage at a dose-level of 2000 mg/kg body weight. The observation period was 14 days. No deaths occurred during the study. Beside unspecific findings like stilted gait and reduced spontaneous activity shortly after dosing, no clinical signs of intoxication were observed during the course of the study. Body weight development was normal and within the range commonly recorded for this strain and age. At necropsy no macroscopic findings were recorded. Based on the findings of this limit-test the median lethal dosage (LD50) of the test item in the rat is greater than 2000 mg/kg body weight.