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EC number: 268-938-5 | CAS number: 68155-09-9
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 20, 1999 to November 24, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- March 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- EC Number:
- 268-938-5
- EC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- Cas Number:
- 68155-09-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- Details on test material:
- - Purity: approximately 81%
- Lot/batch No.: 876 TK
- Physical state: off white paste
- Storage condition of test material: room temperature, in the dark.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Stepan Company, Illinois, USA
- Batch No.of test material: 876 TK
- Date received: 10 May 1999
- Description: white paste
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Freshly prepared as a solution in distilled water
- Final dilution of a dissolved solid: The dose levels were selected using a correction factor based on the purity of the supplied test material, to ensure that the animals received equivalent to 200 or 2000 mg/kg of pure test material
FORM AS APPLIED IN THE TEST: solution
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: males weighed 228 to 236 g, and the females 201 to 236 g
- Fasting period before study: overnight immediately before dosing
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): ad libitum with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): The rate of air exchange was approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): cycles of twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 217.4 mg/ml and 21.8 mg/ml
- Amount of vehicle (if gavage): 10 ml
DOSAGE PREPARATION: The test material solutions were prepared using a correction factor based on the purity of the test substance to ensure that the animals received 2000 and 200 mg/kg of the pure test material
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD
- Rationale for the selection of the starting dose: Using all available information, 2174 mg/kg bodyweight was selected as the starting dose. (This dose level was selected using a correction factor based on the purity of the supplied test material, to ensure that the animals received a dose equivalent to 2000 mg/kg bodyweight of pure test material).
OTHER:
- animals were dosed once only by gavage - Doses:
- 2174 mg/kg (equivalent to 2000 mg pure test material/kg) and 218 mg/kg (equivalent to 200 mg pure test material/kg)
- No. of animals per sex per dose:
- 2174 mg/kg: a group of 3 female rats.
218 mg/kg: 6 rats, one group of 3 females and one group of 3 males - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observation: Death or overt signs of toxicity were checked at 1/2, 1, 2, and four hours after dosing and subsequently once daily
- Frequency of observations and weighing: Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 500 - <= 1 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: Pure test substance
- Mortality:
- Two animals treated with 2174 mg/kg were found dead one or two days after dosing. There were no deaths noted at a dose level of 218 mg/kg.
- Clinical signs:
- other: Clinical signs in animals treated with 2174 mg/kg were hunched posture, diarrhoea and increased salivation with incidents of pallor of the extremities, emaciation, lethargy, pilo-erection, decreased respiratory rate, laboured respiration, red/brown staini
- Gross pathology:
- Necropsy results of animals that died during the study (treated with 2174 mg/kg) were haemorrhagic lungs, dark liver, dark kidneys, haemorragic gastric mucosa, sloughing and/or haemorrhage of the non-glandular epithelium of the stomach and haemorrhagic small and large intestines. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Any other information on results incl. tables
Mortality data
Dose level [mg/kg] |
Animal number and sex |
Number of animals treated |
Deaths during day of dosing (hours) |
Effects noted after dosing (days) |
|||||||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
Deaths |
|||
2174 |
female |
3 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2/3 |
218 |
female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
male |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Individual Clinical Observations
Dose level mg/kg |
Animal Nº and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
2174 |
|
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
18 |
9 |
10 |
11 |
12 |
13 |
14 |
1-0 Female |
H |
H |
HD |
HD |
HPD Ss |
HP |
H |
H |
|
|
|
|
|
|
|
|
|
|
|
1-1 Female |
HS |
HS
|
HSD |
HSD |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1-2 Female |
HS |
HS |
HSD |
HSD |
H P Em Ss Rd RL Wt E |
X |
|
|
|
|
|
|
|
|
|
|
|
|
D: diarrhea E: pallor of extremities
Em: emaciation H: hunched posture
L: lethargy P: pilo-erection
Rd: decreased respiratory rate RL: labored respiration
S: increased salivation Ss: red/brown stainig around snout
Wt: tiptoe gait X: animal death
No clinical observations were noted at the dose of 218 mg/kg.
Body weights
Only the animals that died during the study showed a loss of weight
Dose Level mg/kg |
Animal Nº and sex |
Body weight (g) at day |
Body weight (g) at |
||
2174 |
|
0 |
7 |
14 |
Death |
1-0 Female |
204 |
243 |
246 |
|
|
1-0 Female |
201 |
|
|
175 |
|
1-0 Female |
207 |
|
|
170 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 of the test substance in Sprague-Dawley rats was in the range of 500 – 1000 mg/kg of pure test substance.
- Executive summary:
The Acute Oral toxicity – Acute Toxic Class method study for the test substance was performed in Sprague-Dawley CD strain rats. A stepwise procedure was used; a group of 3 females was treated with a dose of 2174 mg/kg (equivalent to 2000 mg of pure test material/kg) and 2 groups (3 females and 3 males) were treated with a dose of 218 mg/kg (equivalent to 200 mg of pure test material /kg). The test substance was administered as a solution in distilled water. An oral single dose of 10 ml/kg was given by gavage.
Clinical observations were made at 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for up to 14 days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment or at death. All animals including those that died during the study were subjected to gross pathological observations. Two animals treated with 2174 mg/kg died. No mortalities were noted in animals treated with 218 mg/kg. The acute oral LD50 of the test substance in Sprague-Dawley rats was in the range of 500 – 1000 mg/kg of pure test substance.
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