PMID- 35580980
OWN - NLM
STAT- MEDLINE
DCOM- 20220913
LR  - 20221222
IS  - 1099-1263 (Electronic)
IS  - 0260-437X (Linking)
VI  - 42
IP  - 10
DP  - 2022 Oct
TI  - Acceptable surface limits (ASLs) of skin sensitizers derived from the local lymph 
      node assay (LLNA): BrdU-ELISA EC1.6 values and their relationships to known 
      sensitization potency information.
PG  - 1723-1730
LID - 10.1002/jat.4339 [doi]
AB  - Skin sensitization is an extremely important risk factor for occupational health 
      and safety, and it would be desirable to set health-based exposure limits (HBELs) 
      for the quantitative risk assessment (QRA) based on the skin sensitizing 
      potencies of chemical. We attempted to set acceptable surface limits (ASLs) as 
      HBELs for skin sensitizers in the workplace based on the local lymph node assay 
      (LLNA): BrdU-ELISA EC1.6 values. To calculate the ASLs, a safety assessment 
      factor (SAF)(interspecies) value of 6, based on the EC1.6 values/human repeat 
      insult patch test (HRIPT) NOEL ratios, a SAF(interindividual) value of 10, and a 
      SAF(frequency/duration) value of 3 were applied, referring to previous 
      literatures on SAFs for skin sensitization QRA, and the composite SAF was 
      calculated as 180. The ASLs (mg/100 cm(2) ) derived thus for 33 chemicals ranged 
      from 0.001 to 10.417. Comparison of the ranges with known human sensitization 
      potency classes and GHS subcategories revealed that use of GHS Category 1A 
      chemicals needs to be controlled to ensure surface residue levels of less than 
      1 mg/100 cm(2) . To minimize sensitization risks, a quantitative sensitization 
      risk assessment method for chemicals and appropriate risk management are 
      necessary. This report provides a potentially useful ASL-based method of managing 
      sensitization risk derived from LLNA: BrdU-ELISA EC1.6 values, comparison of the 
      ASLs and known human sensitization potency data showed that GHS subcategorization 
      results would be a primary information notifying ASL ranges to be required for 
      minimizing the sensitization risk.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Fukushima, Asako
AU  - Fukushima A
AUID- ORCID: 0000-0001-8913-3173
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute, Tokyo, Japan.
FAU - Hayashi, Tae
AU  - Hayashi T
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute, Tokyo, Japan.
FAU - Takeyoshi, Masahiro
AU  - Takeyoshi M
AUID- ORCID: 0000-0001-8941-2076
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute, Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220522
PL  - England
TA  - J Appl Toxicol
JT  - Journal of applied toxicology : JAT
JID - 8109495
RN  - 0 (Allergens)
RN  - G34N38R2N1 (Bromodeoxyuridine)
SB  - IM
MH  - Allergens/toxicity
MH  - Bromodeoxyuridine
MH  - *Dermatitis, Allergic Contact/etiology
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Humans
MH  - *Local Lymph Node Assay
OTO - NOTNLM
OT  - LLNA: BrdU-ELISA
OT  - acceptable surface limits
OT  - health-based exposure limits
OT  - occupational risk assessment
OT  - quantitative risk assessment
OT  - skin sensitization
EDAT- 2022/05/18 06:00
MHDA- 2022/09/14 06:00
CRDT- 2022/05/17 21:23
PHST- 2022/03/31 00:00 [revised]
PHST- 2022/03/25 00:00 [received]
PHST- 2022/04/01 00:00 [accepted]
PHST- 2022/05/18 06:00 [pubmed]
PHST- 2022/09/14 06:00 [medline]
PHST- 2022/05/17 21:23 [entrez]
AID - 10.1002/jat.4339 [doi]
PST - ppublish
SO  - J Appl Toxicol. 2022 Oct;42(10):1723-1730. doi: 10.1002/jat.4339. Epub 2022 May 
      22.