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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
study used only to support the read-across for other endpoints
Adequacy of study:
key study
Study period:
2012-05-31 to 2012-06-22
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:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethylamino)propyl]stearamide
EC Number:
231-609-1
EC Name:
N-[3-(dimethylamino)propyl]stearamide
Cas Number:
7651-02-7
Molecular formula:
C23H48N2O
IUPAC Name:
N-[3-(dimethylamino)propyl]octadecanamide
Test material form:
solid: pellets

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Fasting period before study: overnight prior to dosing and until approximately 1 hour after the second administration of the test substance
- Housing: 3/cage- Diet (e.g. ad libitum): pelleted rodent diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Air changes (per hr): app. 15/h
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% w/w
- Amount of vehicle (if gavage): 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
2000 mg/kg bw were achieved by administration of two times 1000 mg/kg bw, since a 20% w/w formulation was not homogenous based on trial formulations.
Doses:
2000 mg/kg bw, given as 2 dosages of 1000 mg/kg bw within 24 hours. The first on t=0 and the second on t=3 hours. Multiple dosages given within 24 hours are regarded as a single dose
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: mortality: twice daily; clinical signs: 0, 2, 4 h, daily thereafter
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
2/6 animals died on day 2 and 3, respectively
Clinical signs:
Clinical signs shown by the animals found dead and surviving animals included lethargy, hunched posture, uncoordinated movements, piloerection, diarrhoea, chromodacryorrhoea, pallor, and/or ptosis.The surviving animals had recovered from the symptoms between days 7 and 10.
Body weight:
The two animals found dead showed either slight weight gain or weight loss. 3/4 surviving females showed body weight loss between days 1 and 8. These animals again gained body weight between days 8 and 15. One surviving female showed body weight gain that was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
One female found dead showed watery-turbid fluid in the stomach and watery-clear, yellowish fluid in the small intestines. The other female found dead showed a reduced size of the spleen. Pelvic dilation of the kidneys was noted in one surviving female. Other surviving females had no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of Stearic acid 3-(dimethylaminopropyl)amide in female rats was > 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study according to OECD guideline 423, adopted 17 December 2001 and EU method B.1 tris, May 2008, 6 female, fasted, 8-9 weeks old Wistar strain ratswere given a single oral dose of Stearic acid 3-(dimethylaminopropyl)amide in Propylene glycol by gavage at a dose of 2000 mg/kg bw and observed for 14 days.

The test substance was administered as 2 dosages of 1000 mg/kg bw within 24 hours. The first on t=0 and the second on t=3 hours. Multiple dosages given within 24 hours are regarded as a single dose.

2/6 animals died on day 2 and 3, respectively. Clinical signs shown by the animals found dead and surviving animals included lethargy, hunched posture, uncoordinated movements, piloerection, diarrhoea, chromodacryorrhoea, pallor, and/or ptosis.

The surviving animals had recovered from the symptoms between days 7 and 10.

The two animals found dead showed either slight weight gain or weight loss. 3/4 surviving females showed body weight loss between days 1 and 8. These animals again gained body weight between days 8 and 15. One surviving female showed body weight gain that was considered to be similar to that expected of normal untreated animals of the same age and strain.

One female found dead showed watery-turbid fluid in the stomach and watery-clear, yellowish fluid in the small intestines. The other female found dead showed a reduced size of the spleen. Pelvic dilation of the kidneys was noted in one surviving female. Other surviving females had no macroscopic abnormalities.

 

Oral LD50 (rat, females) > 2000  mg/kg bw