In this study, a risk assessment was conducted to examine the validity of
the domestic use limit for eight ingredients of p-nitro-o-phenylenediamine,
nitro-p-phenylenediamine, 5-amino-6-chloro-o-cresol, p-nitro-o-phenylenediamine
sulfate, p-methylaminophenol, 2,4-diaminophenol dihydrochl...
In this study, a risk assessment was conducted to examine the validity of
the domestic use limit for eight ingredients of p-nitro-o-phenylenediamine,
nitro-p-phenylenediamine, 5-amino-6-chloro-o-cresol, p-nitro-o-phenylenediamine
sulfate, p-methylaminophenol, 2,4-diaminophenol dihydrochloride, 1,5-dihydroxy
naphthalene, 2-methylresorcinol among 48 hair dye ingredients notified by
the Ministry of Food and Drug Safety(MFDS). Also, in order to determine
the safety of local exposure due to the use of hair dye, hair damage was
measured and toxicity tests were performed on scalp-related cells. The
adequacy of the use of allowed hair dye ingredients was evaluated by
combining the risk assessment and research results on hair and scalp. Risk
assessment for these ingredients is carried out in accordance with the
methods and procedures suggested in the ‘Regulation on the risk
assessment of human products.’ (Notice No. 2019-29 of the MFDS) and
‘Guidelines for risk assessment for cosmetics’. It proceeded to 4 stages of
hazard identification, hazard characterization, exposure assessment and risk
characterization. In the hair damage study, it was confirmed whether the
hair was damaged by methods such as methylene blue test, tensile
strength measurement and SEM observation. The cytotoxicity test was
performed using three types of NIH 3T3, RAW 264.7, and B16F10 cell
lines for the four dye ingredients that caused hair damage. As a result of
the research, hair dye ingredients that meet the domestic regulation was
also confirmed, but ingredients with safety concerns were also investigated
because a safety margin was not secured when the current managements
were applied. In particular, some ingredients were investigated as
inappropriate ingredients for domestic use due to lack of data or serious
safety concerns. In the study on hair damage, it was observed that the
damage induction of 4 ingredients, including 2,4-diaminophenol
dihydrochloride, were the greatest when measuring physical and chemical
properties and morphological observation. In the cytotoxicity test, the
toxicity of 2,4-diaminophenol dihydrochloride was the highest when
compared using the LC50 value. When considering the above research
results, p-nitro-o-phenyldiamine and nitro-p-phenylenediamine need to be
considered for changes in domestic regulations by conducting additional
studies on skin sensitization. Since p-nitro-o-phenylenediamine sulfate
cannot be evaluated due to insufficient toxicity data, it is necessary to
consider discontinuing its use in Korea until supplementation is made. The
safety of 5-amino-6-chloro-o-cresol and 2,4-diaminophenol dihydrochloride
was not secured when applying domestic regulations, so prompt change of
management standards is required. Especially, it is considered a
2,4-diaminophenol dihydrochloride that needs to provide more accurate
information to consumers because hair damage and cytotoxicity are
strongly observed. When it is assessed that only the results of
investigation and research on 8 out of 48 domestically allowed hair dye
ingredients can lead to ingredients having problems with the
appropriateness of domestic use, it is necessary to conduct risk assessment
and other additional toxicity studies for all 48 ingredients.
In this study, a risk assessment was conducted to examine the validity of
the domestic use limit for eight ingredients of p-nitro-o-phenylenediamine,
nitro-p-phenylenediamine, 5-amino-6-chloro-o-cresol, p-nitro-o-phenylenediamine
sulfate, p-methylaminophenol, 2,4-diaminophenol dihydrochloride, 1,5-dihydroxy
naphthalene, 2-methylresorcinol among 48 hair dye ingredients notified by
the Ministry of Food and Drug Safety(MFDS). Also, in order to determine
the safety of local exposure due to the use of hair dye, hair damage was
measured and toxicity tests were performed on scalp-related cells. The
adequacy of the use of allowed hair dye ingredients was evaluated by
combining the risk assessment and research results on hair and scalp. Risk
assessment for these ingredients is carried out in accordance with the
methods and procedures suggested in the ‘Regulation on the risk
assessment of human products.’ (Notice No. 2019-29 of the MFDS) and
‘Guidelines for risk assessment for cosmetics’. It proceeded to 4 stages of
hazard identification, hazard characterization, exposure assessment and risk
characterization. In the hair damage study, it was confirmed whether the
hair was damaged by methods such as methylene blue test, tensile
strength measurement and SEM observation. The cytotoxicity test was
performed using three types of NIH 3T3, RAW 264.7, and B16F10 cell
lines for the four dye ingredients that caused hair damage. As a result of
the research, hair dye ingredients that meet the domestic regulation was
also confirmed, but ingredients with safety concerns were also investigated
because a safety margin was not secured when the current managements
were applied. In particular, some ingredients were investigated as
inappropriate ingredients for domestic use due to lack of data or serious
safety concerns. In the study on hair damage, it was observed that the
damage induction of 4 ingredients, including 2,4-diaminophenol
dihydrochloride, were the greatest when measuring physical and chemical
properties and morphological observation. In the cytotoxicity test, the
toxicity of 2,4-diaminophenol dihydrochloride was the highest when
compared using the LC50 value. When considering the above research
results, p-nitro-o-phenyldiamine and nitro-p-phenylenediamine need to be
considered for changes in domestic regulations by conducting additional
studies on skin sensitization. Since p-nitro-o-phenylenediamine sulfate
cannot be evaluated due to insufficient toxicity data, it is necessary to
consider discontinuing its use in Korea until supplementation is made. The
safety of 5-amino-6-chloro-o-cresol and 2,4-diaminophenol dihydrochloride
was not secured when applying domestic regulations, so prompt change of
management standards is required. Especially, it is considered a
2,4-diaminophenol dihydrochloride that needs to provide more accurate
information to consumers because hair damage and cytotoxicity are
strongly observed. When it is assessed that only the results of
investigation and research on 8 out of 48 domestically allowed hair dye
ingredients can lead to ingredients having problems with the
appropriateness of domestic use, it is necessary to conduct risk assessment
and other additional toxicity studies for all 48 ingredients.
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