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EC number: 951-974-7 | CAS number: -
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-02-02 to 2009-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- 30 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 (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- MDEA Esterquat C18 satd.
- IUPAC Name:
- MDEA Esterquat C18 satd.
- Details on test material:
- - Name of test material (as cited in study report):Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride
- Physical state: solid
- Analytical purity: 98.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 223-240 g
- Fasting period before study: 16-19 hours
- Housing: Semi-barrier in an air conditioned room. The animals were kept in groups in IVC cages, type III H, polysulphone
cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): ad libitum (Altromin 1324 maintenance diet)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 20 - 24 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2009-02-02 To: 2009-02-20
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 % w/w
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: non-toxic characteristics
- Lot/batch no. (if required): B. Braun Melsungen, lot 7494A191, expiry date: November 2010
- Purity: aqua ad injectionem
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
DOSAGE PREPARATION (if unusual): The test item was ground to a fine dust with the help of a mortar. Then it was dissolved while stirring and heated up approx. 70 °C in the vehicle. - Doses:
- 2000 mg/kg bw
- 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 and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 0 (prior to the administration) and on days 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: no mortalities
- Mortality:
- No deaths occured during the study
- Clinical signs:
- other: no signs of toxicity
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were recorded for any animal of the two steps.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) 1272/2008)
- Conclusions:
- Under the conditions of the present study, the oral LD50 of MDEA Esterquat C18 satd. in female rats is > 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 (30 May 2008), 6 female, fasted, 8-12 weeks old Wistar strain rats were given a single oral dose of MDEA Esterquat C18 satd. in water (10% w/w) by gavage at the limit dose of 2000 mg/kg bw and observed for 14 days.
All animals survived until the end of the study period. No clinical signs were observed in any animal at any observation timepoint. The body weight of the animals was within the range commonly recorded for this strain and age. No test substance related macroscopic findings were recorded at necropsy.
Oral LD50 (rat, females) > 2000 mg/kg bw
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