Benzyldimethyl(octadecyl)ammonium chloride

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:

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

EC Number:

939-253-5

Molecular formula:

C12-16H25-33-(CH3)2-C6H5-N.CL

IUPAC Name:

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

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

Test material form:

liquid

Remarks:

aqueous formulation

Details on test material:

Appearance: viscous solution (in 50% concentration)
For use: diluted in water

Specific details on test material used for the study:

- ca. 50% Cocobenzyldimethylammonium chloride (CAS no.: 61789-71-7) in water.
- Arquad B-50 is based on full cocoalkylchain: (chain length distribution of
full coco: C8: 5%; C10: 6%; C12: 50%; C14: 19%; C16: 10%; C18:10%.

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

795 mg/kg bw

Based on:

test mat.

95% CL:

>= 585 - <= 1 081

Remarks on result:

other: (795 mg/kg bw equivalent to 397.5 mg a.i./kg bw

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:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of the study, the LD50 of the test substance was considered to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C12-16 ADBAC (active: 50%), according to OECD Guideline 401, in compliance with GLP. Five male and five female rats per dose group were administered the undiluted test substance (50% purity) in a single oral dose by gavage at the dose levels of 500, 794, 1260 and 2000 mg/kg bw. Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 d. 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. Under the conditions of the study, the LD50 of the test substance was considered to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females (combined, with 95% confidence levels of 585 - 1081) (Jones, 1986).