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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 07, 1987 to December 03, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

other: Acute oral toxicity

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-benzyl-N,N-dimethyltetradecan-1-aminium chloride

EC Number:

939-253-5

Cas Number:

68424-85-1

Molecular formula:

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

IUPAC Name:

N-benzyl-N,N-dimethyltetradecan-1-aminium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: undiluted test substance

Doses:

500, 794, 1,260 and 2,000 mg/kg bw

No. of animals per sex per dose:

10

Details on study design:

Dose selection was based upon the results of a range-finding study. Animals, 5 males and 5 females per dose group, were administered the undiluted test substance in a single oral dose by gavage. Animals were observed 1 and 4h after dosing and subsequently once daily for 14 d. Deaths and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the d of treatment (Day 0), Days 7 and 14, and at death. All animals were subjected to gross necropsy examination for any macroscopic abnormalities.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 398 mg/kg bw

Based on:

test mat.

95% CL:

>= 298 - <= 542

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 358 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 247 - <= 519

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 438 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 288 - <= 665

Gross pathology:

Necropsy of decedents revealed abnormally red lungs, dark livers, haemorrhage and ulceration of the gastric mucosa and congestion of the small intestines. Major abnormalities seen at necropsy of animals killed at termination were white thickened areas of the non-glandular region of the stomach. Scattered white raised areas were also noted.

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria

Conclusions:

Under the study conditions, the rat LD50 of the test substance was considered to be 358 mg a.i./kg bw in males, 438 mg a.i./kg bw in f emales and 398 img a.i./kg bw in males and females combined.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C12-16 ADBAC (50% active in water) according to OECD Guideline 401, in compliance with GLP. Based on the results of a range finding study, five male and five female rats per dose group weres administered the undiluted test substance (50% active) by gavage at dose levels of 500, 794, 1260 and 2000 mg/kg bw (i.e., equivalent to 250, 397, 630 and 1000 mg a.i./kg bw). Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days. Mortality and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the day of treatment (Day 0), Days 7 and 14, and at termination. All animals were subjected to gross necropsy examination for any macroscopic abnormalities. One male treated with 1000 mg a.s./kg was found dead six h after dosing; all other deaths were noted one to two days after treatment. Surviving animals made expected bodyweight gains over the study period. Major signs of toxicity observed in both decedent and surviving animals were hunched posture, pilo-erection, decreased respiratory rate, diarrhoea, lethargy and ptosis. Ataxia was noted in animals treated with 397 mg a.s./kg bw and above. There were no survivors following treatment with 630 and 1000 mg a.s./kg. All surviving animals were normal three to four days after treatment.Necropsy of decedents revealed abnormally red lungs, dark livers, haemorrhage and ulceration of the gastric mucosa and congestion of the small intestines. Major abnormalities seen at necropsy of animals killed at termination were white thickened areas of the non-glandular region of the stomach. Scattered white raised areas were also noted. Under the study conditions, the LD50 was determined to be 358 mg a.i./kg bw (95% c.i: 247-519 mg a.s/kg bw) in males, 438 mg a.i./kg bw (95% c.i.: 288 – 665 mg a.s./kg bw) in females and 398 mg a.s./kg bw (95% c.i.: 298 – 542 mg a.s./kg bw) in male and females combined (Jones, 1986).