Registration Dossier
Registration Dossier
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EC number: 916-226-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Principles of method if other than guideline:
- Four groups of 5 male and 5 groups of 5 female Wister rats (average weight 171-177 g) each received per gavage a single dose of 500 to 2300 mg/kg bw Katalysator WAZ 5596 B. The animals were observed for mortality, weight and clinical signs through day 14.
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Benzyldodecylbis(2-hydroxypropyl)ammonium chloride
- EC Number:
- 265-345-3
- EC Name:
- Benzyldodecylbis(2-hydroxypropyl)ammonium chloride
- Cas Number:
- 65059-91-8
- Molecular formula:
- C25H46NO2.Cl
- IUPAC Name:
- N-benzyl-N,N-bis(2-hydroxypropyl)dodecan-1-aminium chloride
- Details on test material:
- Katalysator WAZ 5596 B = benzyldodecylbis(2-hydroxypropyl)ammonium chloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- male rats: 500, 1000, 2000, 2300 mg/kg bw
female rats: 500, 1000, 1300, 1600, 2000 mg/kg bw - No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 457 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
The corresponding mortality for male rats was 0% (500 mg/kg bw), 20% (1000 mg/kg bw), 40% (2000 ml/kg bw), 100% (2300 mg/kg bw), respectively.
The corresponding mortality for female rats was 0% (500 mg/kg bw), 0% (1000 mg/kg bw), 60% (1300 ml/kg bw), 60% (1600 mg/kg bw) and 100% (2000 ml/kg bw) respectively.
A single dose of 1000 to 2300 mg/kg bw Katalysator WAZ 5596 B caused on male and female rats the following signs of intoxication: reduction of general condition, sedation and rough fur. Surroundings of the eye was bloody in 1 male animals dosed with 2000 mg/kg bw and a bloody snout was visible on 2 female animale dosed with 1300 mg/kg bw. Gasping was observed 1 male and 1 female rats dosed with 1000 mg/kg bw. A swelled belly was observed in 1 male rat dosed with 1000 mg/kg bw and a increased diuresis on female animals dosed with 1600 mg/kg bw.A staggered gait was evident on females doses with 1300 or 1300 mg/kg bw.
Additional, with doses of 1000 to 2000 mg/kg bw (males) and 1000 to 1600 mg/kg bw (females) a weight reduction was observed.
Symptoms were evident 2 hour after application and continued until day 11 of the examination period.
Necropsy on animals dosed with 1000 to 2300 mg/kg bw, which died during post-observation period:
stomach mucosa was damaged, stomach and intestines were inflated, partly stomach was adhered with liver, spleen and diaphragm.
Animals dosed with 2300 mg/kg bw showed a strong reddened lung and in the chest cavity a clear reddish fluid was found
Necropsy of animals killed of post-observation period:
animals dosed wth 500 to 1000 mg/kg bw showed were without pathological findings
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information
- Executive summary:
Four or five groups of 5 male and female Wister rats (average weight 171-177 g) each received per gavage a single dose of 500 to 2300 mg/kg bw Katalysator WAZ 5596 B. The animals were observed for mortality, weight and clinical signs through day 14.
As signs of intoxication reduction of general condition, sedation and rough fur, gasping and staggered gait were observed in the dose range of 1000 to 2300 mg/kg bw. body weight gain was retared in the first post-observation period.
A single dose of 500 mg/kg bw Katalysator WAZ 5596 B was tolerated by male and female rats without symptoms; LD50 = 1457 mg/kg bw.
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