PMID- 30626777
OWN - NLM
STAT- MEDLINE
DCOM- 20190124
LR  - 20190124
IS  - 1880-3989 (Electronic)
IS  - 0388-1350 (Linking)
VI  - 44
IP  - 1
DP  - 2019
TI  - The dermal sensitization threshold (DST) approach for mixtures evaluated as 
      negative in in vitro test methods; mixture DST.
PG  - 23-34
LID - 10.2131/jts.44.23 [doi]
AB  - Cosmetic ingredients often comprise complex mixtures, such as botanical extracts, 
      which may contain skin sensitizing constituents. In our previous study for the 
      sensitivity of the evaluations of skin sensitizing constituents in mixtures using 
      the binary in vitro test battery with KeratinoSens(TM) and h-CLAT, some 
      sensitizers showed higher detection limits in in vitro test methods than in 
      murine local lymph node assays (LLNA). Thus, to minimize the uncertainty 
      associated with decreased sensitivity for these sensitizers, a risk assessment 
      strategy was developed for mixtures with negative results from the binary test 
      battery. Assuming that the no expected sensitization induction level of mixtures 
      (mixture NESIL) can be derived for mixtures with negative in vitro test results, 
      we assessed 146 sensitizers with in vitro and LLNA data according to the 
      assumption of indeterminate constituents in mixtures. Finally, we calculated 95th 
      percentile probabilities of mixture NESILs and derived dermal sensitization 
      thresholds for mixtures (mixture DST) with negative in vitro test results of 6010 
      mug/cm(2). Feasibility studies indicated that this approach was practical for risk 
      assessments of products in the cosmetic industry. This approach would be a novel 
      risk assessment strategy for incorporating the DST approach and information from 
      in vitro test methods.
FAU - Nishijo, Taku
AU  - Nishijo T
AD  - Safety Science Research Laboratories, Kao Corporation.
FAU - Miyazawa, Masaaki
AU  - Miyazawa M
AD  - Safety Science Research Laboratories, Kao Corporation.
FAU - Saito, Kazutoshi
AU  - Saito K
AD  - Safety Science Research Laboratories, Kao Corporation.
FAU - Otsubo, Yuki
AU  - Otsubo Y
AD  - Safety Science Research Laboratories, Kao Corporation.
FAU - Mizumachi, Hideyuki
AU  - Mizumachi H
AD  - Safety Science Research Laboratories, Kao Corporation.
FAU - Sakaguchi, Hitoshi
AU  - Sakaguchi H
AD  - Safety Science Research Laboratories, Kao Corporation.
LA  - eng
PT  - Journal Article
PL  - Japan
TA  - J Toxicol Sci
JT  - The Journal of toxicological sciences
JID - 7805798
RN  - 0 (Allergens)
RN  - 0 (Cosmetics)
RN  - 0 (Haptens)
SB  - IM
MH  - Administration, Cutaneous
MH  - Allergens/*toxicity
MH  - Animals
MH  - Cell Line
MH  - Cosmetics/toxicity
MH  - Dermatitis, Allergic Contact
MH  - Dose-Response Relationship, Drug
MH  - Drug Interactions
MH  - Haptens/*toxicity
MH  - Humans
MH  - Mice
MH  - Risk Assessment
MH  - Skin Tests
OTO - NOTNLM
OT  - KeratinoSensTM
OT  - Mixture
OT  - Mixture DST
OT  - Skin sensitization
OT  - h-CLAT
EDAT- 2019/01/11 06:00
MHDA- 2019/01/25 06:00
CRDT- 2019/01/11 06:00
PHST- 2019/01/11 06:00 [entrez]
PHST- 2019/01/11 06:00 [pubmed]
PHST- 2019/01/25 06:00 [medline]
AID - 10.2131/jts.44.23 [doi]
PST - ppublish
SO  - J Toxicol Sci. 2019;44(1):23-34. doi: 10.2131/jts.44.23.