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資料３－３ ストラテラカプセル及びストラテラ内用液にて検出された新規ニトロソアミンの限度値について（企業見解）［7.8MB］ (29 ページ)
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R.A. Jolly et al.
Regulatory Toxicology and Pharmacology 152 (2024) 105672
Fig. 5. a-c. Body Weight Data from the 28-Day Studies.
Fig. 6a. Mutation data - liver.
3.4. Benchmark dose analysis
with the NOEL of 5 mg/kg for all three NDSRIs.
Table 4 shows a summary of NOEL, BMDL, BMD and BMDU values
for NDEA and NDMA from the literature as well as the data from the
current studies on NDSRIs. The data show that NOEL and BMDL values
for the three NDSRIs range from 10 to 100-fold higher than those for
NDMA or NDEA, indicating significantly lower potency of the NDSRIs
The BMD analysis for the mutation data was performed for liver, as
that tissue was the most sensitive in terms of both dose and response.
The BMDL values for liver were 6.3, 6.8 and 4.4 mg/kg for NFLX, NDLX
and NATX respectively. These BMDL values were generally consistent
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Regulatory Toxicology and Pharmacology 152 (2024) 105672
Fig. 5. a-c. Body Weight Data from the 28-Day Studies.
Fig. 6a. Mutation data - liver.
3.4. Benchmark dose analysis
with the NOEL of 5 mg/kg for all three NDSRIs.
Table 4 shows a summary of NOEL, BMDL, BMD and BMDU values
for NDEA and NDMA from the literature as well as the data from the
current studies on NDSRIs. The data show that NOEL and BMDL values
for the three NDSRIs range from 10 to 100-fold higher than those for
NDMA or NDEA, indicating significantly lower potency of the NDSRIs
The BMD analysis for the mutation data was performed for liver, as
that tissue was the most sensitive in terms of both dose and response.
The BMDL values for liver were 6.3, 6.8 and 4.4 mg/kg for NFLX, NDLX
and NATX respectively. These BMDL values were generally consistent
7
29 / 34 ページ