Safety evaluation of food and drug packaging pigments
10.3760/cma.j.cn114015-20241125-00167
- VernacularTitle:食品药品包装颜料的安全性评价
- Author:
Ruomeng YANG
1
;
Lifang WANG
;
Wei DU
;
Shouqian JIA
;
Rundong FENG
Author Information
1. 西安文理学院美术与设计学院设计系，西安 710065
- Publication Type:Journal Article
- Keywords:
Drug packaging;
Biocompatible materials;
Toxicity tests;
Genetic toxicity;
Safety;
Evaluation studies;
Pigment
- From:
Adverse Drug Reactions Journal
2025;27(8):486-494
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the safety of pigments and inks commonly used in food and drug packaging materials.Methods:The acute oral toxicity, skin irritation, and eye irritation tests in 4 different batches of pigment samples (YP-001 to YP-008) and one kind of ink (YP-009) were investigated by animal experiments. Median lethal dose (LD 50), body weight, and stimulation intensity were used as detection indicators. The test sample with LD 50>5 000 mg/kg was judged as practically non-toxicity, the test sample with skin irritation intensity of 0-<0.50 points and eye irritation intensity of 0-3 points were judged as no irritation. Bacterial reverse mutation test, in vitro mammalian chromosome aberration test, and mammalian erythrocyte micronucleus test were carried out on oil paint (YP-007). The number of revertant colonies, chromosome aberration rate, and erythrocyte micronucleus rate were used as the detection indexes. If the number of revertant colonies in each dose group in the test sample was less than 2 times of that in the blank control group, the chromosome aberration rate and erythrocyte micronucleus rate were not statistically significant compared with the negative control group, the test sample was judged to be negative. Results:The acute oral toxicity test showed that the weight of mice in different test groups was not reduced, and the LD 50 was more than 5 000 mg/kg, so the samples were judged to be practically non-toxic, no irritation to skin and eyes of rabbits. The bacterial reverse mutation test showed that the results in 5 different dose groups and 5 repeated dose groups of oil paint test samples were all negative. The in vitro mammalian chromosome aberration test showed that the results in 3 dose groups of oil paint test samples (5.0, 2.5 and 1.25 mg/ml) were all negative. The mammalian erythrocyte micronucleus test showed that the results in 3 dose groups of oil paint test samples (10.0, 5.0 and 2.5 mg/kg) were all negative. Conclusions:The test samples of 4 different batches of pigments and one kind of ink are practically non-toxic and free of skin and eye irritation. The oil paint (YP-007) has no genotoxicity and potential carcinogenicity in vivo and in vitro.
