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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000

Materials and methods

Principles of method if other than guideline:
NTP conducted a 16 day oral gavage study in rats. Due to effects observed, results are also applicable for acute toxicity.
GLP compliance:
not specified
Test type:
other: NTP 16 day oral gavage study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzyltrimethylammonium chloride was obtained from Fluka Chemical Corporation (Ronkonkoma, NY) in one lot (306793/1). Information on the identity, purity, and stability of the bulk chemical was provided by the manufacturer; identity was confirmed by the study laboratory. Reports on analyses performed in support of the benzyltrimethylammonium chloride studies are on file at the National Institute of Environmental Health Sciences.

The manufacturer identified the chemical, an off-white to yellow crystalline powder, as benzyltrimethylammonium chloride by nuclear magnetic resonance spectroscopy. The purity of lot 306793/1, determined by argentometric titration, was 100.4% or greater. The study laboratory confirmed the identity of the chemical with infrared spectroscopy. The spectrum was consistent with a literature reference for benzyltrimethylammonium bromide (Aldrich, 1990).

Based on the manufacturer's stability information, the bulk chemical was stored at room temperature in sealed containers flushed with nitrogen to expel moisture.

Reference:
Aldrich Catalog/Handbook of Fine Chemicals 1990-1991 (1990), p. 146. Aldrich Chemical Company, Inc., Milwaukee, WI.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
Male and female F344/N rats were obtained from Taconic Farms (Germantown, NY). On receipt, the rats were 4 weeks old. Animals were quarantined for 13 (rats) days and were 6 weeks old on the first day of the studies.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Groups of five male and five female rats received 0, 16, 32, 63, 125, or 250 mg benzyltrimethylammonium chloride per kg body weight in deionized water by gavage, 5 days per week for 16 days.
Doses:
0, 16, 32, 63, 125, or 250 mg benzyltrimethylammonium chloride per kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes
Details on study design:
Male and female F344/N rats were obtained from Taconic Farms (Germantown, NY). On receipt, the rats were 4 weeks old. Animals were quarantined for 13 (rats) days and were 6 weeks old on the first day of the studies. Groups of five male and five female rats received 0, 16, 32, 63, 125, or 250 mg benzyltrimethylammonium chloride per kg body weight in deionized water by gavage, 5 days per week for 16 days. Feed and water were available ad libitum. Rats were housed five per cage. Animals were observed daily, and clinical findings and body weights were recorded initially, on day 8, and at the end of the studies. Prior to terminal sacrifice, a functional observation battery was performed on all surviving rats. At the end of the study, the animals were necropsied (additional details provided in the repeated dose section).

Statistics:
Additional details provided in the repeated dose section.

Results and discussion

Mortality:
All male and female rats in the 125 and 250 mg/kg groups died on day 1 of the study. All other rats survived to the end of the study.
Clinical signs:
Chemical-related clinical findings observed in three males and one female administered 125 mg/kg included abnormal breathing, ataxia, lethargy (males only), nasal and eye discharge, and tremors on day 1; one 63 mg/kg male was also lethargic and had nasal and eye discharge.
Body weight:
The final mean body weights and body weight gains of dosed males and females were similar to those of the vehicle controls.
Gross pathology:
See results in the repeated dose section.
Other findings:
See report in repeated dose section.

Any other information on results incl. tables

See report in repeated dose section.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on results of this study, the acute oral LD50 is between 63 and 125 mg/kg.
Executive summary:

The intent of this study was to define the subacute toxicity of benzyltrimethylammonium chloride in rats. Based on the results observed, the acute toxicity of benzyltrimethylammonium chloride was also defined. All rats survived repeated dosing to 63 mg/kg but died following a single dose of 125 or 250 mg/kg. Thus the acute oral LD50 is between 63 and 125 mg/kg.

Based on the results of the 13 week oral gavage study in rats, the acute oral LD50 is between 100 and 125 mg/kg (for further details see the repeated dose section).