Evaluation of subchronic toxicity of the compound of diphenhydramine hydrochloride and caffeine after 28 days of repeated oral administration in Sprague-Dawley rats and beagle dogs

This study was designed to evaluate the subchronic toxicity of the compound of diphenhydramine hydrochloride (DH) and caffeine in Sprague-Dawley (SD) rats and beagle dogs. A total of 180 SD rats (15/sex/group) were randomly divided into the compound low-, medium- and high-dose groups (51, 102, 204 mg/kg), DH group (60 mg/kg), caffeine group (144 mg/kg) and the vehicle control group. Sixty beagle dogs (5/sex/group) were randomly divided into the compound low-, medium- and high-dose groups (male: 14.20, 28.30, 56.60 mg/kg, female: 5.66, 14.20, 28.30 mg/kg), DH group (male: 16.60 mg/kg, female: 8.30 mg/kg), caffeine group (male: 40.00 mg/kg, female: 20.00 mg/kg) and the vehicle control group. Rats and dogs were given continuous oral administration for 28 days following a 28-day recovery period. The adverse effects of the compound on rats and beagle dogs mainly included anorexia and liver function impairment. Most adverse effects induced by administration were reversible. Under the experimental conditions, the no-observed-adverse-effect level (NOAEL) of the compound of DH and caffeine was 51 mg/kg/day for SD rats and 28.30 mg/kg/day (male) and 5.66 mg/kg/day (female) for beagle dogs.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:46

Enthalten in:

Drug and chemical toxicology - 46(2023), 6 vom: 17. Nov., Seite 1083-1099

Sprache:

Englisch

Beteiligte Personen:

Ren, Lijun [VerfasserIn]
Yan, Lang [VerfasserIn]
Shi, Wenjing [VerfasserIn]
Zhang, Tiantian [VerfasserIn]
Geng, Bijiang [VerfasserIn]
Mao, Jingjing [VerfasserIn]
Zhang, Jiqianzhu [VerfasserIn]
Tian, Yijun [VerfasserIn]
Wang, Haoneng [VerfasserIn]
Gao, Fangyuan [VerfasserIn]
Dai, Xiaoyu [VerfasserIn]
Li, Jinfeng [VerfasserIn]
Gu, Jing [VerfasserIn]
Chen, Yun [VerfasserIn]
Zhang, Xiaofang [VerfasserIn]
Chen, Jikuai [VerfasserIn]
Zhu, Jiangbo [VerfasserIn]

Links:

Volltext

Themen:

3G6A5W338E
8GTS82S83M
Caffeine
Diphenhydramine
Diphenhydramine hydrochloride
Dog
Journal Article
Rat
Subchronic toxicity

Anmerkungen:

Date Completed 05.09.2023

Date Revised 05.09.2023

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1080/01480545.2022.2129674

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM348977603