市售儿童化妆品中苯氧乙醇的测定及初步风险特征评估

doi:10.3969/j.issn.2097-2806.2024.02.015

摘要/Abstract

摘要：

研究市售儿童化妆品中苯氧乙醇防腐剂的暴露参数，对其进行初步风险特征描述，旨在为完善我国化妆品安全风险评估体系提供参考。本实验依据《化妆品安全技术规范》（2015年版）（国家药品监督管理局2021年第17号通告）检验，测得市售50批儿童化妆品中苯氧乙醇含量，并通过ConsExpo Web暴露评估软件建立数学模型，获得适用中国儿童化妆品中苯氧乙醇的暴露参数。结果表明：实验所测的50批市售儿童化妆品中，苯氧乙醇的使用频率为50%。0~3岁儿童有吸吮行为，会增加苯氧乙醇的安全边际风险。市售儿童化妆品中苯氧乙醇的安全边际（MoS）均大于50。

结论

儿童化妆品中苯氧乙醇的使用频率较高，市售儿童化妆品中苯氧乙醇的初步风险特征评估为安全。儿童化妆品暴露参数要充分参考到儿童不同年龄段的皮肤特点，儿童特有的行为模式和儿童特定的应用场景，以便更加科学合理地评估儿童化妆品安全。

关键词: 儿童化妆品, 苯氧乙醇, 暴露参数, ConsExpo Web暴露评估软件, 初步风险特征评估

Abstract:

The exposure parameters of phenoxyethanol preservative in children’s cosmetics sold in the market was studied, based on which preliminary risk characteristics were described, so as to provide reference to improve the safety risk assessment system of cosmetics in China. This experiment is based on the inspection method of 《Technical Specification for Safety of Cosmetics》（2015 Edition）（Announcement No. 17 of 2021, National Medical Products Administration）. The content of phenoxyethanol in 50 batches of children’s cosmetics sold in the market were measured, and the mathematical model was established by the ConsExpo Web exposure assessment software to obtain the exposure parameters of phenoxyethanol. The results show that among the 50 batches of commercial children’s cosmetics tested in the experiment, the frequency of use of phenoxyethanol is 50%. Children aged 0-3 years have sucking behavior, which would increase the marginal risk of safety （MoS）, and the margin （MoS） of phenoxyethanol in commercial cosmetics for children is more than 50. This study suggests that phenoxyethanol in children’s cosmetics is used frequently, and the preliminary risk characteristics of phenoxyethanol in children’s cosmetics on the market are evaluated as safe. The exposure parameters of children’s cosmetics should fully take into account the skin characteristics of children at different ages, children’s specific behavior patterns and child-specific application scenarios, so as to scientifically and reasonably evaluate the safety of children’s cosmetics.

Key words: children’s cosmetics, phenoxyethanol, exposure parameters, ConsExpo Web exposure assessment software, preliminary risk assessment

中图分类号:

TQ658

王任, 吴鸳鸯, 乔佳, 颜琳琦, 陈岑, 张丽媛. 市售儿童化妆品中苯氧乙醇的测定及初步风险特征评估[J]. 日用化学工业（中英文）, 2024, 54(2): 224-230.

Ren Wang, Yuanyang Wu, Jia Qiao, Linqi Yan, Cen Chen, Liyuan Zhang. Study on phenoxyethanol content in children’s cosmetics on the mark and preliminary risk assessment[J]. China Surfactant Detergent & Cosmetics, 2024, 54(2): 224-230.

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年龄/month	体重/kg
0~1	2.4
1~3	4.5
3~6	6.1
6~12	8.0
12~24	9.8
24~36	12.4
36~72	15.7
72~132	24.3
132~192	44.8

样品序号	含量/%	剂型	平均值/%
1	0.51	水剂型	0.44
2	0.49
3	0.38
4	0.28
5	0.47
6	0.60
7	0.29
8	0.51
9	0.58	乳液剂型	0.31
10	0.15
11	0.29
12	0.18
13	0.50
14	0.12
15	0.16	膏霜剂型	0.36
16	0.14
17	0.44
18	0.52
19	0.42
20	0.51
21	0.17
22	0.52
23	0.17	粉剂型	0.37
24	0.45
25	0.49

项目	产品剂型	使用频率/ （次/d）	每次使用量/ （g/次）	每日使用量/ （g/d）
苯氧乙醇	水	2	0.135	0.270
	乳液
	膏霜
	粉		0.400	0.800

年龄/month	体重/kg	乳霜水剂型		2次/天暴露量/ （mg/kg·bw/day）	6次/天暴露量/ （mg/kg·bw/day）
年龄/month	体重/kg	皮肤暴露量/ （mg/kg· bw/day）	经口暴露量/ （mg/kg·bw/day）	2次/天暴露量/ （mg/kg·bw/day）	6次/天暴露量/ （mg/kg·bw/day）
0~1	2.4	0.810	0.000 590	0.810 590	2.431 770
1~3	4.5	0.430	0.001 200	0.442 000	1.326 000
3~6	6.1	0.320	0.000 086	0.320 086	0.960 258
6~12	8.0	0.240	0.000 066	0.240 066	0.720 198
12~24	9.8	0.200	0.000 041	0.200 041	0.600 123
24~36	12.4	0.160	0.000 035	0.160 035	0.480 105
36~72	15.7	0.120		0.120 000	0.360 000
72~132	24.3	0.080		0.080 000	0.240 000
132~192	44.8	0.043		0.043 000	0.129 000

年龄/month	体重/kg	粉剂型		2次/天暴露量/ （mg/kg· bw/day）	6次/天暴露量/ （mg/kg· bw/day）
年龄/month	体重/kg	皮肤暴露量/ （mg/kg· bw/day）	经口暴露量/ （mg/kg· bw/day）	2次/天暴露量/ （mg/kg· bw/day）	6次/天暴露量/ （mg/kg· bw/day）
0~1	2.4	2.2	0.001 60	2.201 60	6.604 80
1~3	4.5	1.2	0.000 85	1.208 50	3.602 55
3~6	6.1	0.87	0.000 64	0.870 64	2.611 92
6~12	8.0	0.54	0.000 15	0.540 15	1.620 45
12~24	9.8	0.54	0.000 11	0.540 11	1.620 33
24~36	12.4	0.43	0.009 60	0.439 60	1.318 80
36~72	15.7	0.11		0.110 00	0.330 00
72~132	24.3	0.22		0.220 00	0.660 00
132~192	44.8	0.043		0.120 00	0.360 00