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Toxicological information

Acute Toxicity: oral

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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:
2009
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

Constituent 1
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%

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:
no signs of toxicity
Body weight:
None of the animals showed weight loss during the observation period
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