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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:
August 15, 2016 - November 23, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
May 30, 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: CD / Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 162 - 195 g
- Fasting period before study: approx. 16 hours before administration
- Housing: n groups of 3 animals in MAKROLON cages (type III plus)
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 12 - 18
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.38 mL/kg b.w.
Doses:
2000 mg a.i./kg bw
No. of animals per sex per dose:
6 females (3 in each step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- - Frequency of observations: before and immediately, 5, 15, 30, and 60 min, as well as 3, 6, and 24 hours after administration, least once a day afterwards
- Frequency of weighing: before administration of the test item and thereafter in weekly intervals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
No histopathology was carried out as no macroscopical findings were noted at autopsy.
Statistics:
No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
One of the 6 animals died prematurely on test day 7.
Clinical signs:
No clinical signs were observed.
Body weight:
One animal showed a reduced body weight gain.
Gross pathology:
No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of Di-C12-18 alkyldimethyl ammonium chloride in rat exceeds 2000 mg a.i./kg bw.
Executive summary:

In an acute oral toxicity study according to OECD Guideline 423 (December 17, 2001) and EU Method B.1 tris (May 30, 2008), 2 groups of 3 fasted, approx. 8 weeks old, female CD / Crl: CD(SD) rats were given a single oral dose of Di-C12-18 alkyldimethyl ammonium chloride (68% a.i.) by gavage at a limit dose of 2000 mg a.i./kg bw and observed for 14 days.

One of the 6 animals died prematurely on test day 7. No clinical signs were observed. One animal showed a reduced body weight gain. No pathological changes were observed at necropsy.

 

Oral LD50 females >2000 mg a.i./kg bw