Evaluation of ocular irritancy of coal-tar dyes used in cosmetics employing reconstructed human cornea-like epithelium and short time exposure tests

Lee, Miri; Nam, Ki Taek; Kim, Jungah; Lim, Song E.; Yeon, Sang Hyeon; Lee, Buhyun; Lee, Joo Young; Lim, Kyung-Min

doi:10.1016/j.fct.2017.08.001

Cited by 16Contact Dermatitis and AllergiesDye analysis and toxicityAnimal testing and alternatives

The DOI matches its Crossref record; 43 of the 43 references it cites were found in a registry or an index.

Evaluation of ocular irritancy of coal-tar dyes used in cosmetics employing reconstructed human cornea-like epithelium and short time exposure tests

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Lee, Miri, Nam, Ki Taek, Kim, Jungah, Lim, Song E., Yeon, Sang Hyeon, Lee, Buhyun, Lee, Joo Young, Lim, Kyung-Min·2017·Food and Chemical Toxicology

DOI 10.1016/j.fct.2017.08.001

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Abstract

Coal-tar dyes in cosmetics may elicit adverse effects in the skin and eyes. Countries, like the US, have banned the use of coal-tar dyes in cosmetics for the eye area due to the potential for ocular irritation. We evaluated the eye irritation potential of 15 coal-tar dyes permitted as cosmetic ingredients in reconstructed human cornea-like epithelium (RhCEs [EpiOcular™ and MCTT HCE™]) tests and the short time exposure (STE) test. Eosin YS, phloxine B, tetrachlorotetrabromofluorescein, and tetrabromofluorescein were identified as irritants in RhCEs; dibromofluorescein and uranine yielded discrepant results. STE enabled further classification in accordance with the UN Globally Harmonized System of Classification and Labelling of Chemicals, as follows: eosin YS as Cat 2; phloxine B, Cat 1; and tetrachlorotetrabromofluorescein and tetrabromofluorescein, Cat 1/2. STE indicated dibromofluorescein (irritant in EpiOcular™) and uranine (irritant in MCTT HCE™) as No Cat, resulting in the classification of "No prediction can be made." based on bottom-up approach with each model. These results demonstrated that in vitro eye irritation tests can be utilized to evaluate the potential ocular irritancy of cosmetic ingredients and provide significant evidence with which to determine whether precautions should be given for the use of coal-tar dyes in cosmetics or other substances applied to the eye area.

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Coal tar can cause cancer and organ system toxicity worldwide.
“The detrimental effects of coal tar on human health have been frequently reported by numerous epidemiological studies worldwide, and it has been estimated that it can cause cancer and organ system toxicity worldwide.”
From The dark side of beauty: an in-depth analysis of the health hazards and toxicological impact of synthetic cosmetics and personal care products (2024) · cites this paper as [60]
Direct exposure to coal tar via the skin can cause skin irritation and neurological system dysfunction.
“Direct exposure to this toxic chemical via the skin can cause skin irritation and neurological system dysfunction (60).”
From The dark side of beauty: an in-depth analysis of the health hazards and toxicological impact of synthetic cosmetics and personal care products (2024) · cites this paper as [60]
Coal tar dyes can cause visual impairment when applied to eyebrows and eyelid lashes.
“According to Lee et al. (60), coal tar dyes can cause visual impairment when applied to eyebrows and eyelid lashes.”
From The dark side of beauty: an in-depth analysis of the health hazards and toxicological impact of synthetic cosmetics and personal care products (2024) · cites this paper as Lee et al. (60)

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The dark side of beauty: an in-depth analysis of the health hazards and toxicological impact of synthetic cosmetics and personal care products
Alnuqaydan, A. M. (2024) · Frontiers in Public Health · doi:10.3389/fpubh.2024.1439027 · Cited by 84

Authors: Lee, M., Nam, K. T., Kim, J., Lim, S. E., Yeon, S. H., Lee, B., Lee, J. Y., & Lim, K.-M.
Affiliations: Ewha Womans University (KR)
Yonsei University (KR)
Catholic University of Korea (KR)
Corresponding author: Lee, Miri
Lim, Song E.
Lee, Buhyun
Lee, Joo Young
Lim, Kyung-Min
ORCID: Nam, Ki Taek
Lee, Buhyun
Lee, Joo Young
Lim, Kyung-Min
Venue: Food and Chemical Toxicology
Publisher: Elsevier BV
Published: 2017-10
Volume: 108
Issue: Pt A
Pages: 236-243
ISSN: 0278-6915 (ISSN-L)
DOI: 10.1016/j.fct.2017.08.001
OpenAlex: W2745206754
Cited by: 16
References: 43
Citations by year: 2026: 2 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 1 · 2020: 2 · 2019: 3 · 2018: 3 · 2017: 1
FWCI: 2.80
Type: journal article
Language: en
Open access: green
ir.ymlib.yonsei.ac.kr
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Food and Chemical Toxicology (publishedVersion)
PubMed (publishedVersion)
YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Funders: Ministry of Food and Drug Safety (14172MFDS97, 16182MFDS522)
Topics: Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
Physical Sciences › Chemistry › Analytical Chemistry › Dye analysis and toxicity
Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
Keywords: coal tar dyes, eye irritation, cosmetic ingredients, eosin Y, phloxine B, fluorescein, bottom-up approach
MeSH terms: Animal Testing Alternatives, Coal Tar, Cosmetics, Coloring Agents, Humans, Irritants, Epithelium, Corneal, Toxicity Tests, Acute

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Evaluation of ocular irritancy of coal-tar dyes used in cosmetics employing reconstructed human cornea-like epithelium and short time exposure tests

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