PMID- 37661367
OWN - NLM
STAT- MEDLINE
DCOM- 20230905
LR  - 20230905
IS  - 1880-3989 (Electronic)
IS  - 0388-1350 (Linking)
VI  - 48
IP  - 9
DP  - 2023
TI  - Comparison of the acceptable surface limits derived from the skin sensitization 
      potency for workers and swab residue limits determined from the permitted daily 
      exposure derived from the systemic effects.
PG  - 507-511
LID - 10.2131/jts.48.507 [doi]
AB  - Allergic contact dermatitis is a common occupational and environmental health 
      problem and setting of health-based exposure limits (HBELs) to prevent induction 
      of skin sensitization is strongly desired. When manufacturing pharmaceuticals in 
      a shared facility, cleaning validation using surface residue levels (SRLs) 
      derived from permitted daily exposures (PDEs) is conducted to avoid 
      cross-contamination from the perspective of protecting patients; however, it is 
      unclear whether the SRLs are sufficient to prevent induction of skin 
      sensitization for workers as well. In this study, we compared acceptable surface 
      limits (ASLs) derived from acceptable exposure levels (AELs) based on EC1.6 
      obtained from local lymph node assay (LLNA): BrdU-ELISA for occupational risk 
      management of skin sensitizers with PDE-based SRLs. ASLs for 1,4-phenylenediamine 
      (GHS skin sensitization sub-category 1A), isoeugenol (sub-category 1A), and 
      methyl methacrylate (sub-category 1B) were compared with SRLs based on the PDEs 
      derived from their systemic effects. The results yielded an SRL for 
      1,4-phenylenediamine (PDE: 0.8 mg/day) of 30 mg/100 cm(2), almost 1,000 times 
      higher than ASL (0.031 mg/100 cm(2)) derived from its skin sensitization potency. 
      SRL for isoeugenol (PDE: 3.1 mg/day) was 130 mg/100 cm(2), over 500 times higher 
      than ASL (0.18 mg/100 cm(2)). For methyl methacrylate (PDE: 5 mg/day) as well, 
      SRL (200 mg/100 cm(2)) was higher, but it was within 20 times the ASL (10 mg/100 
      cm(2)). These results showed that ASL-based risk management is extremely 
      important especially for strong sensitizers classified as GHS sub-category 1A for 
      occupational skin sensitization risk management.
FAU - Fukushima, Asako
AU  - Fukushima A
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute.
FAU - Hayashi, Tae
AU  - Hayashi T
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute.
FAU - Takeyoshi, Masahiro
AU  - Takeyoshi M
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute.
LA  - eng
PT  - Journal Article
PL  - Japan
TA  - J Toxicol Sci
JT  - The Journal of toxicological sciences
JID - 7805798
RN  - U770QIT64J (4-phenylenediamine)
RN  - 47341-71-9 (diethylstilbestrol monophosphate)
RN  - 5M0MWY797U (isoeugenol)
RN  - 196OC77688 (Methylmethacrylate)
RN  - 0 (Methacrylates)
SB  - IM
MH  - Humans
MH  - *Skin
MH  - Methylmethacrylate
MH  - *Methacrylates
OTO - NOTNLM
OT  - Acceptable surface limits
OT  - HBEL
OT  - LLNA: BrdU-ELISA
OT  - Skin sensitization
EDAT- 2023/09/04 06:43
MHDA- 2023/09/05 06:41
CRDT- 2023/09/04 00:52
PHST- 2023/09/05 06:41 [medline]
PHST- 2023/09/04 06:43 [pubmed]
PHST- 2023/09/04 00:52 [entrez]
AID - 10.2131/jts.48.507 [doi]
PST - ppublish
SO  - J Toxicol Sci. 2023;48(9):507-511. doi: 10.2131/jts.48.507.