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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
EC Number:
221-083-1
EC Name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
Cas Number:
3001-63-6
Molecular formula:
C23H49ClNO.Cl
IUPAC Name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
Constituent 2
Chemical structure
Reference substance name:
Propane-1,2-diol
EC Number:
200-338-0
EC Name:
Propane-1,2-diol
Cas Number:
57-55-6
Molecular formula:
C3H8O2
IUPAC Name:
propylene glycol
Test material form:
liquid
Details on test material:
Aqueous solution

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mass: 127-168 g (male); 130-156 g (female), Age: 48-56 Days (male) .; 59-70 Days (female)
Acclimatization time before start of test: 5 days
Feeding: Standardized Laboratory Animal Feed ALTROMIN®, Hydration:Water ad libitum. room temperature: 21 ° C +/- 2 ° C, Relative humidity: 50 - 60%, Room lighting: 12 hrs. Illuminated tube lighting /12 hours Darkness,
room hygiene: Laboratory and cage cleaning by means of Commercial antiseptic, instrument disinfection and sterilization with autoclave and hot air sterilizer

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test product was in the form of a liquid of yellowish color and was applied undiluted. pH 5.85, Density 0.99g/ml. Application volume 2.15 ml/kg - 5.62 ml/kg. These volumes corresponded to a dosage range between 2129 and 5207 mg / kg
Doses:
2.15-5.62 ml / kg
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
3 784 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
5 137 mg/kg bw
Mortality:
The deaths took place mostly between the 4th and 6th day following application. Later death cases also occurred after 9 to 13 days.
Clinical signs:
A substance-specific poisoning picture could not be raised in either male or female animals. Irrespective of the dose in the test, their well-being was negatively impacted 1 to 3 days after the application of the test product, during which diarrhea and ruffled coat were observed, followed by a reduction in body weight (slowing of weight gain), A dose of 2.15 ml is at the limit of the non-toxic to the beginning toxic dosage range

Any other information on results incl. tables

 Dose (ml/kg)  Sex  Mortality (x/n)  Mortality (%)
 2.15  0/5  0
 3.16  M  0/5  0
 3.83  M  1/5  20
 4.64  M  4/5  80
 5.62  M  3/5  60
 2.15  F  0/5  0
 3.16  F  1/5  20
 3.83  F  3/5  60
 4.64  F  4/5  80
 5.62  F  4/5  80

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on LD50 of 3784 mg/kg of the test solution (40% solution of the active ingredient), the LD50 of (3-Chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride would be 1514 mg/kg.