(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride

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:

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

Test material information

Constituent 1

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)dimethyloctadecylazanium chloride

Constituent 2

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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

3 784 mg/kg bw

Effect levels 2

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:

other: 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 ru

Any other information on results incl. tables

Dose (ml/kg)	Sex	Mortality (x/n)	Mortality (%)
2.15	M	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.