Benzododecinium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, comparable to scientific principles/standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Acute oral toxicity was determined by oral administration of the test substance to nine dose groups of male and female rats and subsequent observations of clinical signs and mortality for 14 days. The LD50 was calculated from the mortality data recorded in the study.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides

Molecular formula:

C12-14H25-29-(CH3)2-C6H5-N.CL

IUPAC Name:

Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides

Specific details on test material used for the study:

- Analytical purity: >93%
- Stability under test conditions: Test substance is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least five years under standard laboratory conditions.

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
- Age at study initiation: Young adult rats
- Weight at study initiation: 200-300 g
- Fasting period before study: 24h
- Diet: Ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Propylene glycol for 1 mL/kg bw and lower doses and undiluted test substance for doses 2 mL/kg bw and above dose levels.

Details on oral exposure:

Vehicle:
- Amount of vehicle: Propylene glycol for 1 mL/kg bw and all lower doses. Higher doses were administered undiluted.

Doses:

0.25, 0.32, 0.40, 0.50, 1.0, 2.0, 4.0, 8.0 and 16.0 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14d
- Frequency of observations: Daily
- Necropsy of survivors performed: No

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.43 mL/kg bw

Based on:

test mat.

95% CL:

>= 0.39 - <= 0.47

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

344 mg/kg bw

Based on:

act. ingr.

Mortality:

0/5, 0/5 and 1/5 animals died at 0.25, 0.32 and 0.40 mL/kg bw dose levels respectively. All animals in the higher dose groups (0.50 to 16.00 mL/kg bw) died during the study period.

Clinical signs:

other: All animals dosed at 0.25 to 0.50 mL/kg bw exhibited lethargy and slight to moderate diarrhea. The severity of the symptoms increased proportionately to the dose level received. Surviving animals returned to normal within 5 days of dosing. Animals dosed a

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria

Conclusions:

Under the conditions of the study, the LD50 of the test substance was 0.43 mL/kg bw (95% c.i.-0.39 - 0.47 mL/kg bw). After correcting for 100% active test substance, the LD50 was determined to be 344 mg a.i./kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (50-80% active), in albino rats. The test substance was administered to groups of five fasted male and female albino rats at 0.25, 0.32, 0.40, 0.50, 1.0, 2.0, 4.0, 8.0 or 16.0 mL/kg bw. Propylene glycol was used as vehicle for 1 mL/kg and all lower doses. Doses of 2 mL/kg bw and above were administered as received. Animals were observed for 14 d post-dosing. No post-mortem nor histopathological examinations were performed. 0/5, 0/5 and 1/5 animals died at 0.25, 0.32 and 0.40 mL/kg bw, respectively. All animals in the higher dose levels died during the study period. Under the conditions of the study, the LD50 of the test substance is considered to be 0.43 mL/kg bw (95% c.i.-0.39 - 0.47 mL/kg bw). After correcting for 100% active test substance, the LD50 is determined to be 344 mg a.i./kg bw (Wallace, 1975).