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Description of key information

The acute oral toxicity of benzyltrimethylammonium chloride was examined in rats and mice. All rats survived and gained weight following oral administration of 50 mg/kg.  An old study reported a rat oral LD50 of 250 mg/kg but not further information was available.  All mice dosed with benzyltrimethylammonium chloride died following an acute oral dose of 1600 mg/kg.
Two groups of five rats/sex were exposed using a nose-only inhalation exposure system, to time-weighted average chamber concentration of 0.64 or 2.03 mg benzyltrimethylammonium chloride per liter of air. All animals died during exposure to 2.03 mg/L (100% mortality by 97 minutes of exposure. All animals survived the four-hour exposure to 0.64 mg/L as well as the two-week post-exposure observation period. Based on these data, the calculated four-hour LC50 of inhaled particulate benzyltrimethylammonium chloride is 1.14 mg/L for male and female F344/DuCrl rats.
The dermal LD50 values of BTMAC-60% in rabbits were calculated to be 633 mg/kg body weight for the males, 410 mg/kg body weight for the females and 510 mg/kg body weight for the sexes combined. Due to the mortality distribution, no fiducial limits could be determined for the LD50 values for males and females.
The dermal toxicity of the test material was examined at one dose level, 200 mg/kg. All rabbits dosed dermally with 200 mg/kg test material died. One rabbit survived for at least 24 hours post dosing, all others died within 24 hours.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
115 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
1 140 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
510 mg/kg bw

Additional information

Based on the results of the oral gavage 16 day and 13 week NTP studies in rats and mice the acute oral LD50 is ~115 mg/kg in rats (based on lethality of all rats at 125 and 250 mg/kg in the 16 day study and essentially complete survival of all rats at 100 mg/kg in the 13 week study) and slightly higher in mice (based on lethality of all mice at 250 mg/kg and higher and 10% mortality (1 of 5 females and 0 of 5 males) at 125 mg/kg in the 16 day study). An acute oral study with BTMAC-60% reported the LD50 was between 25 and 200 mg/kg.

The calculated four-hour LC50 of inhaled particulate benzyltrimethylammonium chloride is 1.14 mg/L for male and female F344/DuCrl rats.

The dermal LD50 values of BTMAC-60% in rabbits were calculated to be 633 mg/kg body weight for the males, 410 mg/kg body weight for the females and 510 mg/kg body weight for the sexes combined. Due to the mortality distribution, no fiducial limits could be determined for the LD50 values for males and females.

Justification for classification or non-classification

According to CLP/GHS, BTMAC solid and as 60% solution meet criteria to be labelled as: toxic if swallowed (H301); toxic in contact with skin (H311); harmful if inhaled (H332).