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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dibutyloleamide
EC Number:
227-410-4
EC Name:
N,N-dibutyloleamide
Cas Number:
5831-80-1
Molecular formula:
C26H51NO
IUPAC Name:
N,N-Dibutyloleamide
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 Aktiengesellschaft , Kastengrund, SPF breeding colony
- Age at study initiation: 7-8 weeks
- Weight at study initiation: m: 179 g; f: 161 g
- Fasting before study: yes

- Diet (e.g. ad libitum): ssniff R/M-H (v 1534), ad líbitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least one day (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 50 + 20 %

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Oleum sesami Ph. Eur. III, Fa. Mainland Pharmazeutische Fabrik GmbH
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily observation; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
None
Clinical signs:
other: None
Gross pathology:
No relevant findings
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of Ölsäuredibutylamid 7O% for the male and female Wistar rat is greater than 2000 mg/kg body weight
Executive summary:

The animals received the compound by oral gavage as a 20% solution in sesame oil, the application volume being 10 ml/kg body weight.

Results: No deaths occurred during the whole study. Development of body weight was not impaired. No symptcms were observed after application of 2000 mg/kg body weight. The animals killed at the end of the observation period showed no macroscopically visible changes.

Based on the results obtained in this study the median lethal dose value (LD50) of Ölsäuredibutylamid 70% for the male and female Wistar rat is greater than 2000 mg/kg body weight