Center For The Evaluation Of Risks To Human Reproduction ...

1 NTP-CERHR: propylene glycol 1/7 Center For The Evaluation Of Risks To Human Reproduction NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of propylene glycol March 2004 NIH Publication No. 04-4482 NTP (NTP-CERHR) NTP-CERHR March 2004 NIH Publication No. 04-4482 (CAS No: 57-55-6) 2009 3 NTP-CERHR: propylene glycol 2/7 propylene glycol (CAS No: 5) NTP-CERHR Monograph (NIH Publication No. 04-4482, March 2004) NTP (NTP Brief on propylene glycol ) II propylene glycol (Appendix II. propylene glycol Expert Panel Report) 5 NTP ? PG C3H8O2 Fig. 1 PG / PG FDA generally recognized as safe=GRAS PG 1999 1,083 PG 854 PG PG PG PG 1 4 3 5 PG ?

2 1 PG PG PG PG PG PG PG 1 NTP-CERHR: propylene glycol 3/7 PG 70 kg 34 mg/kg / [ mg/kg / =1 1 ] PG GRAS PG PG 2 4 PG PG 8 TWA8 50 ppm TWA8 10 mg/m3 PG ? PG Fig. 2 NTP Fig.

3 2 PG PG 1,230 mg/kg / 10,400 mg/kg / 1,600 mg/kg / 1,550 mg/kg / PG NTP-CERHR: propylene glycol 4/7 NTP PG 10,100 mg/kg / PG PG PG 8 10 PG PG ? PG 8 10 PG 34 mg/kg / NTP Fig. 3 NTP PG CERHR EG/PG PG NTP-CERHR: propylene glycol 5/7 Appendix II.

4 NTP-CERHR EXPERT PANEL REPORT ON THE REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF propylene glycol , SUMMARIES, CONCLUSIONS AND CRITICAL DATA NEEDS CD-1 6 15 Wistar 6 15 6 10 Dutch-belted 6 18 g/kg / g/kg / g/kg / g/kg / g/kg / 2 g/kg g/kg 5 NAD 50/50 DL- L- D- L- D.

5 L- L- 2 L- 45% 88% NTP-CERHR: propylene glycol 6/7 75% D- 5 8 10 NTP 5% w/v [ g/kg / ] 1999 1,083 854 % 228 170 135 85 10% / 55 40 25 32 84 2,400 mg/ [ 70 kg 34 mg/kg / ]

6 AIHA WEEL 8 TWA 50 ppm 10 mg/m3 Laitinen Norb ck NTP-CERHR: propylene glycol 7/7 350 g/m3 12,700 g/m3 mg/L mg/g mg/L mg/g NIOSH HHE 6 10 21 mg/m3 15 mg/m3 5 15 8 10 NOAEL z NOAEL 10 g/kg / z NOAEL g/kg / z NOAEL g/kg / z NOAEL g/kg / LD50 8 46 g/kg >15 g/kg

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