Prenatal developmental toxicity of alkyl dimethyl benzyl ammonium chloride and didecyl dimethyl ammonium chloride in CD rats and New Zealand White rabbits. 2021

Keith A Hostetler, and Louan C Fisher, and Benjamin L Burruss
Toxicology Regulatory Services, Charlottesville, Virginia, USA.

The prenatal developmental toxicity potential of alkyl dimethyl benzyl ammonium chloride (ADBAC) and didecyl dimethyl ammonium chloride (DDAC) was evaluated in regulatory-compliant studies. Pregnant female CD rats (25/group) and New Zealand White rabbits (16/group) were administered ADBAC (0, 10, 30, or 100 mg/kg/day and 0, 1, 3, or 9 mg/kg/day, respectively), or DDAC (0, 1, 10, or 20 mg/kg/day and 0, 1, 3, or 10 mg/kg/day, respectively), by oral gavage on gestation days (GD) 6-15 for rats and GD 6-18 for rabbits. At scheduled termination (GD 21 for rats; GD 29 for rabbits), maternal necropsies were conducted and live fetuses were weighed and examined for external, visceral, and skeletal malformations and variations. Clinical signs of maternal toxicity were observed in rats and rabbits dosed with ADBAC, resulting in no-observed-adverse-effect levels (NOAELs) of 10 and 3 mg/kg/day, respectively. Despite the treatment-related maternal toxicity of ADBAC, the NOAEL for prenatal developmental toxicity was 100 and 9 mg/kg/day for rats and rabbits, respectively, the highest doses evaluated. Repeated oral doses of DDAC resulted in maternal toxicity in both species at the top two doses, with 25% mortality noted in rabbits at 10 mg/kg/day. No teratogenic effects were observed at any dose for either species. However, increased incidence of dead fetuses per litter and decreased fetal body weights were observed in rabbits at the maternally lethal dose of 10 mg/kg/day. The NOAEL for maternal toxicity of DDAC was 1 mg/kg/day for both species and the NOAEL for prenatal developmental toxicity was 20 and 3 mg/kg/day, for rats and rabbits, respectively.

UI MeSH Term Description Entries
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011817 Rabbits A burrowing plant-eating mammal with hind limbs that are longer than its fore limbs. It belongs to the family Leporidae of the order Lagomorpha, and in contrast to hares, possesses 22 instead of 24 pairs of chromosomes. Belgian Hare,New Zealand Rabbit,New Zealand Rabbits,New Zealand White Rabbit,Rabbit,Rabbit, Domestic,Chinchilla Rabbits,NZW Rabbits,New Zealand White Rabbits,Oryctolagus cuniculus,Chinchilla Rabbit,Domestic Rabbit,Domestic Rabbits,Hare, Belgian,NZW Rabbit,Rabbit, Chinchilla,Rabbit, NZW,Rabbit, New Zealand,Rabbits, Chinchilla,Rabbits, Domestic,Rabbits, NZW,Rabbits, New Zealand,Zealand Rabbit, New,Zealand Rabbits, New,cuniculus, Oryctolagus
D002712 Chlorides Inorganic compounds derived from hydrochloric acid that contain the Cl- ion. Chloride,Chloride Ion Level,Ion Level, Chloride,Level, Chloride Ion
D005260 Female Females
D000643 Ammonium Chloride An acidifying agent that has expectorant and diuretic effects. Also used in etching and batteries and as a flux in electroplating. Sal Ammoniac,Ammoniac, Sal,Chloride, Ammonium
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001548 Benzalkonium Compounds A mixture of alkylbenzyldimethylammonium compounds. It is a bactericidal quaternary ammonium detergent used topically in medicaments, deodorants, mouthwashes, as a surgical antiseptic, and as a as preservative and emulsifier in drugs and cosmetics. Benzalkonium,Benzalkonium Chloride,Alkyldimethylbenzylammonium Chloride,Asepsol,BTC-2125,Drapolene,Germex,Osvan,Zephiran,BTC 2125,BTC2125,Chloride, Alkyldimethylbenzylammonium,Chloride, Benzalkonium,Compounds, Benzalkonium
D051381 Rats The common name for the genus Rattus. Rattus,Rats, Laboratory,Rats, Norway,Rattus norvegicus,Laboratory Rat,Laboratory Rats,Norway Rat,Norway Rats,Rat,Rat, Laboratory,Rat, Norway,norvegicus, Rattus
D019055 No-Observed-Adverse-Effect Level The highest dosage administered that does not produce toxic effects. NOAEL,No-Observed-Effect Level,Acceptable Daily Intake,Tolerable Daily Intake,Acceptable Daily Intakes,Daily Intake, Acceptable,Daily Intake, Tolerable,Daily Intakes, Acceptable,Daily Intakes, Tolerable,Intake, Acceptable Daily,Intake, Tolerable Daily,Intakes, Acceptable Daily,Intakes, Tolerable Daily,Level, No-Observed-Adverse-Effect,Level, No-Observed-Effect,Levels, No-Observed-Adverse-Effect,Levels, No-Observed-Effect,No Observed Adverse Effect Level,No Observed Effect Level,No-Observed-Adverse-Effect Levels,No-Observed-Effect Levels,Tolerable Daily Intakes
D020567 Fetal Weight The weight of the FETUS in utero. It is usually estimated by various formulas based on measurements made during PRENATAL ULTRASONOGRAPHY. Body Weight, Fetal,Body Weights, Fetal,Fetal Body Weight,Fetal Body Weights,Fetal Weights,Weight, Fetal,Weights, Fetal

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