Dibenzyldimethylammonium 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:

other: no guideline was followed, observation period was only 7 days, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Principles of method if other than guideline:

Method: BASF test

GLP compliance:

no

Remarks:

GLP was not compulsatory at this time

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibenzyldimethylammonium chloride

EC Number:

202-903-7

EC Name:

Dibenzyldimethylammonium chloride

Cas Number:

100-94-7

Molecular formula:

C16H20N.Cl

IUPAC Name:

dibenzyldimethylammonium chloride

Test material form:

liquid

Specific details on test material used for the study:

- appearance: liquid
- content: 50% in water

Test animals

Species:

rat

Strain:

not specified

Remarks:

Gassner

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Doses: 8000, 6400, 5000, 4000, 3200, 2500 cmm/kg.
Concentration: 30% (v/v) aqueous solution

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days.
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weights.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 300 other: mm3/kg

Remarks on result:

other: worst case assumption: equivalent to LD50 = 1815 mg/kg considering the substance density and the 50% content of the substance in the test material

Mortality:

See table 1.
All animals exposed to 5000 cmm/kg and above deceased within 15 minutes. Surviving animals showed accelerated breathing and hunched position 2 hours after application, but no adverse effects were observed at day 3 and thereafter.

Clinical signs:

Directly after application accelerated breathing, tremors, apathy, abdominal position and clonic convulsions were observed.

Body weight:

Mean body weights wre determined to be 241.2 g for males and 167.1 g for females.

Gross pathology:

venous congestion

Any other information on results incl. tables

Table 1: Mortalities

Dose cmm/kg	Concentration	Number of animals	Number of deceased animals within
			1 h	24 h	48 h	7 d
8000	30%	10 M	10/10	10/10	10/10	10/10
		10 F	10/10	10/10	10/10	10/10
6400	30%	10 M	10/10	10/10	10/10	10/10
		10 F	10/10	10/10	10/10	10/10
5000	30%	10 M	10/10	10/10	10/10	10/10
		10 F	10/10	10/10	10/10	10/10
4000	30%	10 M	9/10	9/10	9/10	9/10
		10 F	9/10	10/10	10/10	10/10
3200	30%	10 M	3/10	3/10	3/10	3/10
		10 F	5/10	5/10	5/10	5/10
2500	30%	10 M	0/10	0/10	0/10	0/10
		10 F	0/10	2/10	2/10	2/10

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

oral LD50 (rat) = 1815 mg/kg bw

Executive summary:

10 rats per sex and dose were exposed to single doses of 2500, 3200, 4000, 5000, 6400 and 8000 cmm/kg test substance/kg via gavage. Directly after application accelerated breathing, tremors, apathy, abdominal position and clonic convulsions were observed. Within a 7 -day observation period, 2/20, 8/20, 19/20, 20/20, 20/20 and 20/20 animals died in the dose groups of 2500, 3200, 4000, 5000, 6400 and 8000 cmm/kg. Necropsy revealed venous congestion in deceased animals. A LD50 of 3300 cmm/kg was determined. The test material was an aqueous solution of the test subtance, containing 50% test substance. It is unclear whether the LD50 refers to the test material or pure test substance. Considering the test substance density, the LD50 of 3300 cmm/kg was converted to 3630 mg/kg. Applying a worst case approach, the LD50 was corrected to 1815 mg/kg bw accounting for the water content in the test material.