Registration Dossier
Registration Dossier
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EC number: 947-726-2 | CAS number: -
Acute Toxicity: oral
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:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides
- EC Number:
- 269-924-1
- EC Name:
- Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides
- Cas Number:
- 68391-05-9
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- Molecular formula:
- C3H8O
- IUPAC Name:
- propan-2-ol
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system 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:
- other: No clinical signs were observed.
- 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
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