| CIR_vision_codex |
NOAEL |
=400 |
mg/kg bw |
rat |
oral |
14 days |
oral toxicity |
{"citation":"10; 6; 14","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights...","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in hig","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_001"} |
| CIR_vision_codex |
NOAEL |
=1000 |
mg/kg bw |
rat |
oral |
14 days |
repeated dose toxicity |
{"citation":"6; 14; 0, 100, 200","dose":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Buty...","effect":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in high dose animals 10 poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-men...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_002"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/day |
rat |
oral |
46 day |
repeated dose toxicity |
{"citation":"2; 12; 46","dose":"CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating a...","effect":",2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating and continuing through breeding (2 wks), gestation (3 wks), and lactation (4 days) NOEL – 100 mg/kg bw/day, for clinical observations, higher absolute and relative liver wts, and increased incidence of liver and thyroid gland hypertrophy 500 mg/kg/day: treatment-related transient clinical observations in males and females during all phases of the study, including perioral soiling (all animals), muscle twitches (6/12 males, 11/12 females), uncoordinated gait (0/ 12 males, 6/12 females), and decreased activity (0/12 males, 3/12 females); all effects resolved within 1 h of dosing -No significant effects on body wt or body wt gain, feed consumption, hemato...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_003"} |
| CIR_vision_codex |
NOAEL |
>750 |
mg/kg |
rat |
oral |
2-wk |
oral toxicity |
{"citation":"11; 1; (2","dose":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- p...","effect":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Sprague- Dawley rats/ sex 2-wk In feed 0, 250, 500, or 750 mg/kg bw In accord with OECD guideline 407; feed study NOAEL – >750 mg/kg 9 (continued) 22S International Journal of Toxicology 41(Supplement 1)","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_004"} |
| CIR_vision_codex |
NOAEL |
=3244 |
mg/m3 |
rat |
inhalation |
11 days |
inhalation toxicity |
{"citation":"10; (98; 8","dose":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study:","effect":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study: 10 Fischer 344 and 5 Sprague- Dawley rats/sex recovery: additional 10 sex/strain control and high dose 11 days None 0, 540, 1622, and 3244 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk; a 4-wk recovery group was used with each strain hematologic, clinical chemistry, and urinalysis parameters were examined NOAEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative...","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_005"} |
| CIR_vision_codex |
NOAEL |
>3785 |
mg/m3 |
rat |
- |
6 h/day |
NOAEL study |
{"citation":"344; (244; 13,49","dose":"6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al.","effect":"AEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al. 23S","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_006"} |
| CIR_vision_codex |
NOAEL |
=320 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"10; 1; (2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammato","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_007"} |
| CIR_vision_codex |
NOAEL |
=200 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"1; (2; 2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of t...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_008"} |
| CIR_vision_codex |
NOAEL |
=880 |
mg/kg bw |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"320; 9; 1","dose":"9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application...","effect":"ose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_009"} |
| CIR_vision_codex |
NOAEL |
=1.76 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"880; 9,13,36; 5","dose":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl...","effect":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_010"} |
| CIR_vision_codex |
NOAEL |
=10 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"5; 91; 2","dose":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 etha...","effect":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight to moderate edema, slight to moderate atonia, moderate desquamation, and slight to moderate fissuring. -Skin lesions were considered to be a direct, local effect from the solvents and the clipping procedure. -No clinical signs of toxicity 9 (continued) 24S International Journal of Toxicology 41(Supplement 1)","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_011"} |
| CIR_vision_codex |
NOAEL |
=91 |
mg/kg/day |
rat |
oral |
- |
oral toxicity |
{"citation":"35; 1; (2","dose":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats...","effect":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats/sex 13 wks Propylene glycol 0, 91, 273, or 910 mg/ kg bw/day In accord with OECD Guideline 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_012"} |
| CIR_vision_codex |
NOAEL |
=350 |
mg/kg bw |
rat |
oral |
- |
oral toxicity |
{"citation":"411; 5; 91","dose":"5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups:","effect":"ine 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative kidney weights increased in high dose females with no accompanying histopathology -No changes in organs selected for examination, including the testes 9,13 PPG-3 Butyl Ether 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, or 1000 mg/kg bw Administered in drinking water NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg bw -Histopathological and organ weight alterations of liver and kidney (males) and liver (females) (details not provided) 30 (continu...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_013"} |
| CIR_vision_codex |
NOAEL |
=450 |
mg/kg |
rat |
oral |
- |
oral toxicity |
{"citation":"10; 1; (2","dose":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl E...","effect":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 20 Sprague- dawley rats/ sex; additional 5 for interim sacrifice 13 wks In feed 0, 200, 450, or 1000 mg/kg bw In accord with OECD Guideline 408; feed study NOAEL – 450 mg/kg LOAEL – 1000 mg/kg -High-dose males: slight but statistically significant decrease in body wts, enlarged livers with histopathological changes, increased absolute, and relative liver weights; some changes in clinical chemistry corroborated liver changes -High-dose females: absolute and relative kidney weights were increased in high dose females with no accompanying histopathology 9 CMC, carboxymethylcellulose; LOAEL, lowest-observed adverse effect level; NOAEL, no-observed adverse effect level; NOEL, no-observed effect level; NZW, New Zealand White. 26S...","page":22,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_014"} |
| CIR_vision_codex |
NOAEL |
>100 |
mg/ kg bw/day |
rat |
- |
days 7-18 of gestation |
developmental toxicity |
{"citation":"9,11,17; (100; 19","dose":"19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic o...","effect":"s, uterus, kidneys, and liver wts comparable for test and control groups. -No test-article related visceral and skeletal malformations, anomalies, or variants 9,11,17 Propylene Glycol Butyl Ether (100% pure) Gravid NZW rabbits; 19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic or teratogenic effects -Mild erythema in the high dose group occurred at a greater incidence and severity compared to other groups 9,10,17 PPG-2 Butyl Ether 20 gravid Wistar rats Not stated 0, 0.3, 1 mL/kg The test substance was applied dermally on days 6-16 of gestation; details were not provided Maternal and developmental NOEL – > 1 mL/kg -Local skin reactions observed in all treated animals; no signs of maternal toxicity -No reproductive or teratogenic effects 17 (continued) Fiume et al. 27S","page":23,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_015"} |
| CIR_vision_codex |
NOAEL |
=500 |
mg/kg/day |
rat |
oral |
- |
repeated dose toxicity |
{"citation":"9; 11; 1,2","dose":"CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the...","effect":"oups - Pre- and post-implantation loss, number of viable fetuses, and fetal weights and lengths comparable between treatment and control groups, no signs of developmental toxicity - Not embryotoxic, fetotoxic, or teratogenic 9-11 Oral poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the offspring 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) (99.34% pure) 12 Crl:CD (SD) rats/sex 0.5% methylcellulose 0, 100, 300, or 1000 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10 NOEL for reproductive effects – 1000 mg/kg/day - No treatment-related effects on any repr...","page":24,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_016"} |
| CIR_vision_codex |
NOAEL |
=0.047 |
g/kg/d |
rat |
oral |
14-d |
repeated dose toxicity |
{"citation":"(18; 7; 10","dose":"PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study.","effect":"eeding study involving dogs, no sta- tistically significant differences in the incidence of gross or microscopic lesions (18 tissues) between groups of animals fed PPG-7-Buteth-10 (0.004, 0.02, 0.1, and 0.5 g/kg/d) and control groups were observed. Similar results were reported for PPG-33-Buteth-45, following administration to groups of dogs at dietary doses of 0.023, 0.11, and 0.61 g/kg/day. PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study. In 90-d feeding studies, the no-observed effect levels (NOELs) of PPG BE400, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_017"} |
| CIR_vision_codex |
NOAEL |
=0.5 |
g/kg/d |
rat |
oral |
5 d |
repeated dose toxicity |
{"citation":"0, 800, 910; 0; 047","dose":"When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d.","effect":"0, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG BE400 was <0.1 mL/kg/d. When dogs and rats were fed PPG BE800 and 910 for up to 2 yr, the NOELs were up to 0.5 g/kg/d.1 The short-term and subchronic toxicity studies summarized below are described in Table 10. No new repeated-dose dermal, oral, or inhalation toxicity data were available for PPG-3 Butyl Ether. Appropriate read-across materials were identified for dermal subchronic toxicity, oral short-term and subchronic toxicity, and short-term inhalation toxicity testing, and those data are included in this table. In dermal studies, effects on rabbit skin...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_018"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/d |
rat |
oral |
- |
developmental toxicity |
{"citation":"2; 1; 0","dose":"Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied...","effect":"y Studies PPG-2 Butyl Ether when dermally applied was nontoxic to pregnant rats and was non-teratogenic at doses up to 1.0 mL/ kg/d.1 The developmental and reproductive toxicity (DART) studies summarized below are described in Table 11. Ap- propriate read-across materials were identified for dermal and oral DART testing, and those data are included in this table. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation).9,10,17 Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2- ol was not embryotoxic, fetotoxic, or teratogenic in rats.9-11 No test-article related adverse developmental or repro- ductive effects were observed in rats dosed by gavage (days 7– 16 of gestation) with up to 1000 mg/kg Buteth-3.31 No effects on reproducti...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_020"} |
| CIR_vision_codex |
NOAEL |
=0 |
mg/ m3 |
rat |
oral |
- |
developmental toxicity |
{"citation":"1; 450; (2","dose":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg.","effect":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg. A NOAEL of 450 mg/kg was reported in rats fed a diet containing 1-(2-butoxy-1-methylethoxy)-propan-2-ol. In short-term inhalation studies (nine 6-h exposures) in rats, the NOAEL for Propylene Glycol Butyl Ether was 3785 mg/m3 and for 1-(2-butoxy-1-methylethoxy)-propan-2-ol was ≥200 mg/ m3. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but it did not produce reproductive or teratogenic effects (NOEL >1 mL/kg). Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation) or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation). Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2-ol was not em- bryotoxic, fetotoxic, or teratogenic in rats. No test-article related adverse developmental or re- productive effects were observed in rats dosed by gavage (days 7–16 of gestation) with up to 1000 mg/kg Buteth-3. No effects on reproduction were observed in ra...","page":36,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_021"} |
| CIR_vision_codex |
NOAEL |
=400 |
mg/kg bw |
rat |
oral |
14 days |
oral toxicity |
{"citation":"10; 6; 14","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights...","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in hig","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_001"} |
| CIR_vision_codex |
NOAEL |
=1000 |
mg/kg bw |
rat |
oral |
14 days |
repeated dose toxicity |
{"citation":"6; 14; 0, 100, 200","dose":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Buty...","effect":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in high dose animals 10 poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-men...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_002"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/day |
rat |
oral |
46 day |
repeated dose toxicity |
{"citation":"2; 12; 46","dose":"CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating a...","effect":",2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating and continuing through breeding (2 wks), gestation (3 wks), and lactation (4 days) NOEL – 100 mg/kg bw/day, for clinical observations, higher absolute and relative liver wts, and increased incidence of liver and thyroid gland hypertrophy 500 mg/kg/day: treatment-related transient clinical observations in males and females during all phases of the study, including perioral soiling (all animals), muscle twitches (6/12 males, 11/12 females), uncoordinated gait (0/ 12 males, 6/12 females), and decreased activity (0/12 males, 3/12 females); all effects resolved within 1 h of dosing -No significant effects on body wt or body wt gain, feed consumption, hemato...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_003"} |
| CIR_vision_codex |
NOAEL |
>750 |
mg/kg |
rat |
oral |
2-wk |
oral toxicity |
{"citation":"11; 1; (2","dose":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- p...","effect":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Sprague- Dawley rats/ sex 2-wk In feed 0, 250, 500, or 750 mg/kg bw In accord with OECD guideline 407; feed study NOAEL – >750 mg/kg 9 (continued) 22S International Journal of Toxicology 41(Supplement 1)","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_004"} |
| CIR_vision_codex |
NOAEL |
=3244 |
mg/m3 |
rat |
inhalation |
11 days |
inhalation toxicity |
{"citation":"10; (98; 8","dose":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study:","effect":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study: 10 Fischer 344 and 5 Sprague- Dawley rats/sex recovery: additional 10 sex/strain control and high dose 11 days None 0, 540, 1622, and 3244 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk; a 4-wk recovery group was used with each strain hematologic, clinical chemistry, and urinalysis parameters were examined NOAEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative...","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_005"} |
| CIR_vision_codex |
NOAEL |
>3785 |
mg/m3 |
rat |
- |
6 h/day |
NOAEL study |
{"citation":"344; (244; 13,49","dose":"6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al.","effect":"AEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al. 23S","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_006"} |
| CIR_vision_codex |
NOAEL |
=320 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"10; 1; (2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammato","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_007"} |
| CIR_vision_codex |
NOAEL |
=200 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"1; (2; 2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of t...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_008"} |
| CIR_vision_codex |
NOAEL |
=880 |
mg/kg bw |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"320; 9; 1","dose":"9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application...","effect":"ose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_009"} |
| CIR_vision_codex |
NOAEL |
=1.76 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"880; 9,13,36; 5","dose":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl...","effect":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_010"} |
| CIR_vision_codex |
NOAEL |
=10 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"5; 91; 2","dose":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 etha...","effect":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight to moderate edema, slight to moderate atonia, moderate desquamation, and slight to moderate fissuring. -Skin lesions were considered to be a direct, local effect from the solvents and the clipping procedure. -No clinical signs of toxicity 9 (continued) 24S International Journal of Toxicology 41(Supplement 1)","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_011"} |
| CIR_vision_codex |
NOAEL |
=91 |
mg/kg/day |
rat |
oral |
- |
oral toxicity |
{"citation":"35; 1; (2","dose":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats...","effect":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats/sex 13 wks Propylene glycol 0, 91, 273, or 910 mg/ kg bw/day In accord with OECD Guideline 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_012"} |
| CIR_vision_codex |
NOAEL |
=350 |
mg/kg bw |
rat |
oral |
- |
oral toxicity |
{"citation":"411; 5; 91","dose":"5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups:","effect":"ine 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative kidney weights increased in high dose females with no accompanying histopathology -No changes in organs selected for examination, including the testes 9,13 PPG-3 Butyl Ether 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, or 1000 mg/kg bw Administered in drinking water NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg bw -Histopathological and organ weight alterations of liver and kidney (males) and liver (females) (details not provided) 30 (continu...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_013"} |
| CIR_vision_codex |
NOAEL |
=450 |
mg/kg |
rat |
oral |
- |
oral toxicity |
{"citation":"10; 1; (2","dose":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl E...","effect":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 20 Sprague- dawley rats/ sex; additional 5 for interim sacrifice 13 wks In feed 0, 200, 450, or 1000 mg/kg bw In accord with OECD Guideline 408; feed study NOAEL – 450 mg/kg LOAEL – 1000 mg/kg -High-dose males: slight but statistically significant decrease in body wts, enlarged livers with histopathological changes, increased absolute, and relative liver weights; some changes in clinical chemistry corroborated liver changes -High-dose females: absolute and relative kidney weights were increased in high dose females with no accompanying histopathology 9 CMC, carboxymethylcellulose; LOAEL, lowest-observed adverse effect level; NOAEL, no-observed adverse effect level; NOEL, no-observed effect level; NZW, New Zealand White. 26S...","page":22,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_014"} |
| CIR_vision_codex |
NOAEL |
>100 |
mg/ kg bw/day |
rat |
- |
days 7-18 of gestation |
developmental toxicity |
{"citation":"9,11,17; (100; 19","dose":"19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic o...","effect":"s, uterus, kidneys, and liver wts comparable for test and control groups. -No test-article related visceral and skeletal malformations, anomalies, or variants 9,11,17 Propylene Glycol Butyl Ether (100% pure) Gravid NZW rabbits; 19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic or teratogenic effects -Mild erythema in the high dose group occurred at a greater incidence and severity compared to other groups 9,10,17 PPG-2 Butyl Ether 20 gravid Wistar rats Not stated 0, 0.3, 1 mL/kg The test substance was applied dermally on days 6-16 of gestation; details were not provided Maternal and developmental NOEL – > 1 mL/kg -Local skin reactions observed in all treated animals; no signs of maternal toxicity -No reproductive or teratogenic effects 17 (continued) Fiume et al. 27S","page":23,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_015"} |
| CIR_vision_codex |
NOAEL |
=500 |
mg/kg/day |
rat |
oral |
- |
repeated dose toxicity |
{"citation":"9; 11; 1,2","dose":"CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the...","effect":"oups - Pre- and post-implantation loss, number of viable fetuses, and fetal weights and lengths comparable between treatment and control groups, no signs of developmental toxicity - Not embryotoxic, fetotoxic, or teratogenic 9-11 Oral poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the offspring 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) (99.34% pure) 12 Crl:CD (SD) rats/sex 0.5% methylcellulose 0, 100, 300, or 1000 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10 NOEL for reproductive effects – 1000 mg/kg/day - No treatment-related effects on any repr...","page":24,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_016"} |
| CIR_vision_codex |
NOAEL |
=0.047 |
g/kg/d |
rat |
oral |
14-d |
repeated dose toxicity |
{"citation":"(18; 7; 10","dose":"PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study.","effect":"eeding study involving dogs, no sta- tistically significant differences in the incidence of gross or microscopic lesions (18 tissues) between groups of animals fed PPG-7-Buteth-10 (0.004, 0.02, 0.1, and 0.5 g/kg/d) and control groups were observed. Similar results were reported for PPG-33-Buteth-45, following administration to groups of dogs at dietary doses of 0.023, 0.11, and 0.61 g/kg/day. PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study. In 90-d feeding studies, the no-observed effect levels (NOELs) of PPG BE400, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_017"} |
| CIR_vision_codex |
NOAEL |
=0.5 |
g/kg/d |
rat |
oral |
5 d |
repeated dose toxicity |
{"citation":"0, 800, 910; 0; 047","dose":"When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d.","effect":"0, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG BE400 was <0.1 mL/kg/d. When dogs and rats were fed PPG BE800 and 910 for up to 2 yr, the NOELs were up to 0.5 g/kg/d.1 The short-term and subchronic toxicity studies summarized below are described in Table 10. No new repeated-dose dermal, oral, or inhalation toxicity data were available for PPG-3 Butyl Ether. Appropriate read-across materials were identified for dermal subchronic toxicity, oral short-term and subchronic toxicity, and short-term inhalation toxicity testing, and those data are included in this table. In dermal studies, effects on rabbit skin...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_018"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/d |
rat |
oral |
- |
developmental toxicity |
{"citation":"2; 1; 0","dose":"Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied...","effect":"y Studies PPG-2 Butyl Ether when dermally applied was nontoxic to pregnant rats and was non-teratogenic at doses up to 1.0 mL/ kg/d.1 The developmental and reproductive toxicity (DART) studies summarized below are described in Table 11. Ap- propriate read-across materials were identified for dermal and oral DART testing, and those data are included in this table. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation).9,10,17 Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2- ol was not embryotoxic, fetotoxic, or teratogenic in rats.9-11 No test-article related adverse developmental or repro- ductive effects were observed in rats dosed by gavage (days 7– 16 of gestation) with up to 1000 mg/kg Buteth-3.31 No effects on reproducti...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_020"} |
| CIR_vision_codex |
NOAEL |
=0 |
mg/ m3 |
rat |
oral |
- |
developmental toxicity |
{"citation":"1; 450; (2","dose":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg.","effect":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg. A NOAEL of 450 mg/kg was reported in rats fed a diet containing 1-(2-butoxy-1-methylethoxy)-propan-2-ol. In short-term inhalation studies (nine 6-h exposures) in rats, the NOAEL for Propylene Glycol Butyl Ether was 3785 mg/m3 and for 1-(2-butoxy-1-methylethoxy)-propan-2-ol was ≥200 mg/ m3. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but it did not produce reproductive or teratogenic effects (NOEL >1 mL/kg). Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation) or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation). Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2-ol was not em- bryotoxic, fetotoxic, or teratogenic in rats. No test-article related adverse developmental or re- productive effects were observed in rats dosed by gavage (days 7–16 of gestation) with up to 1000 mg/kg Buteth-3. No effects on reproduction were observed in ra...","page":36,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_021"} |
| CIR_vision_codex |
NOAEL |
=400 |
mg/kg bw |
rat |
oral |
14 days |
oral toxicity |
{"citation":"10; 6; 14","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights...","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in hig","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_001"} |
| CIR_vision_codex |
NOAEL |
=1000 |
mg/kg bw |
rat |
oral |
14 days |
repeated dose toxicity |
{"citation":"6; 14; 0, 100, 200","dose":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Buty...","effect":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in high dose animals 10 poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-men...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_002"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/day |
rat |
oral |
46 day |
repeated dose toxicity |
{"citation":"2; 12; 46","dose":"CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating a...","effect":",2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating and continuing through breeding (2 wks), gestation (3 wks), and lactation (4 days) NOEL – 100 mg/kg bw/day, for clinical observations, higher absolute and relative liver wts, and increased incidence of liver and thyroid gland hypertrophy 500 mg/kg/day: treatment-related transient clinical observations in males and females during all phases of the study, including perioral soiling (all animals), muscle twitches (6/12 males, 11/12 females), uncoordinated gait (0/ 12 males, 6/12 females), and decreased activity (0/12 males, 3/12 females); all effects resolved within 1 h of dosing -No significant effects on body wt or body wt gain, feed consumption, hemato...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_003"} |
| CIR_vision_codex |
NOAEL |
>750 |
mg/kg |
rat |
oral |
2-wk |
oral toxicity |
{"citation":"11; 1; (2","dose":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- p...","effect":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Sprague- Dawley rats/ sex 2-wk In feed 0, 250, 500, or 750 mg/kg bw In accord with OECD guideline 407; feed study NOAEL – >750 mg/kg 9 (continued) 22S International Journal of Toxicology 41(Supplement 1)","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_004"} |
| CIR_vision_codex |
NOAEL |
=3244 |
mg/m3 |
rat |
inhalation |
11 days |
inhalation toxicity |
{"citation":"10; (98; 8","dose":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study:","effect":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study: 10 Fischer 344 and 5 Sprague- Dawley rats/sex recovery: additional 10 sex/strain control and high dose 11 days None 0, 540, 1622, and 3244 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk; a 4-wk recovery group was used with each strain hematologic, clinical chemistry, and urinalysis parameters were examined NOAEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative...","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_005"} |
| CIR_vision_codex |
NOAEL |
>3785 |
mg/m3 |
rat |
- |
6 h/day |
NOAEL study |
{"citation":"344; (244; 13,49","dose":"6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al.","effect":"AEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al. 23S","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_006"} |
| CIR_vision_codex |
NOAEL |
=320 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"10; 1; (2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammato","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_007"} |
| CIR_vision_codex |
NOAEL |
=200 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"1; (2; 2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of t...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_008"} |
| CIR_vision_codex |
NOAEL |
=880 |
mg/kg bw |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"320; 9; 1","dose":"9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application...","effect":"ose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_009"} |
| CIR_vision_codex |
NOAEL |
=1.76 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"880; 9,13,36; 5","dose":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl...","effect":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_010"} |
| CIR_vision_codex |
NOAEL |
=10 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"5; 91; 2","dose":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 etha...","effect":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight to moderate edema, slight to moderate atonia, moderate desquamation, and slight to moderate fissuring. -Skin lesions were considered to be a direct, local effect from the solvents and the clipping procedure. -No clinical signs of toxicity 9 (continued) 24S International Journal of Toxicology 41(Supplement 1)","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_011"} |
| CIR_vision_codex |
NOAEL |
=91 |
mg/kg/day |
rat |
oral |
- |
oral toxicity |
{"citation":"35; 1; (2","dose":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats...","effect":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats/sex 13 wks Propylene glycol 0, 91, 273, or 910 mg/ kg bw/day In accord with OECD Guideline 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_012"} |
| CIR_vision_codex |
NOAEL |
=350 |
mg/kg bw |
rat |
oral |
- |
oral toxicity |
{"citation":"411; 5; 91","dose":"5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups:","effect":"ine 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative kidney weights increased in high dose females with no accompanying histopathology -No changes in organs selected for examination, including the testes 9,13 PPG-3 Butyl Ether 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, or 1000 mg/kg bw Administered in drinking water NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg bw -Histopathological and organ weight alterations of liver and kidney (males) and liver (females) (details not provided) 30 (continu...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_013"} |
| CIR_vision_codex |
NOAEL |
=450 |
mg/kg |
rat |
oral |
- |
oral toxicity |
{"citation":"10; 1; (2","dose":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl E...","effect":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 20 Sprague- dawley rats/ sex; additional 5 for interim sacrifice 13 wks In feed 0, 200, 450, or 1000 mg/kg bw In accord with OECD Guideline 408; feed study NOAEL – 450 mg/kg LOAEL – 1000 mg/kg -High-dose males: slight but statistically significant decrease in body wts, enlarged livers with histopathological changes, increased absolute, and relative liver weights; some changes in clinical chemistry corroborated liver changes -High-dose females: absolute and relative kidney weights were increased in high dose females with no accompanying histopathology 9 CMC, carboxymethylcellulose; LOAEL, lowest-observed adverse effect level; NOAEL, no-observed adverse effect level; NOEL, no-observed effect level; NZW, New Zealand White. 26S...","page":22,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_014"} |
| CIR_vision_codex |
NOAEL |
>100 |
mg/ kg bw/day |
rat |
- |
days 7-18 of gestation |
developmental toxicity |
{"citation":"9,11,17; (100; 19","dose":"19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic o...","effect":"s, uterus, kidneys, and liver wts comparable for test and control groups. -No test-article related visceral and skeletal malformations, anomalies, or variants 9,11,17 Propylene Glycol Butyl Ether (100% pure) Gravid NZW rabbits; 19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic or teratogenic effects -Mild erythema in the high dose group occurred at a greater incidence and severity compared to other groups 9,10,17 PPG-2 Butyl Ether 20 gravid Wistar rats Not stated 0, 0.3, 1 mL/kg The test substance was applied dermally on days 6-16 of gestation; details were not provided Maternal and developmental NOEL – > 1 mL/kg -Local skin reactions observed in all treated animals; no signs of maternal toxicity -No reproductive or teratogenic effects 17 (continued) Fiume et al. 27S","page":23,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_015"} |
| CIR_vision_codex |
NOAEL |
=500 |
mg/kg/day |
rat |
oral |
- |
repeated dose toxicity |
{"citation":"9; 11; 1,2","dose":"CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the...","effect":"oups - Pre- and post-implantation loss, number of viable fetuses, and fetal weights and lengths comparable between treatment and control groups, no signs of developmental toxicity - Not embryotoxic, fetotoxic, or teratogenic 9-11 Oral poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the offspring 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) (99.34% pure) 12 Crl:CD (SD) rats/sex 0.5% methylcellulose 0, 100, 300, or 1000 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10 NOEL for reproductive effects – 1000 mg/kg/day - No treatment-related effects on any repr...","page":24,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_016"} |
| CIR_vision_codex |
NOAEL |
=0.047 |
g/kg/d |
rat |
oral |
14-d |
repeated dose toxicity |
{"citation":"(18; 7; 10","dose":"PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study.","effect":"eeding study involving dogs, no sta- tistically significant differences in the incidence of gross or microscopic lesions (18 tissues) between groups of animals fed PPG-7-Buteth-10 (0.004, 0.02, 0.1, and 0.5 g/kg/d) and control groups were observed. Similar results were reported for PPG-33-Buteth-45, following administration to groups of dogs at dietary doses of 0.023, 0.11, and 0.61 g/kg/day. PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study. In 90-d feeding studies, the no-observed effect levels (NOELs) of PPG BE400, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_017"} |
| CIR_vision_codex |
NOAEL |
=0.5 |
g/kg/d |
rat |
oral |
5 d |
repeated dose toxicity |
{"citation":"0, 800, 910; 0; 047","dose":"When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d.","effect":"0, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG BE400 was <0.1 mL/kg/d. When dogs and rats were fed PPG BE800 and 910 for up to 2 yr, the NOELs were up to 0.5 g/kg/d.1 The short-term and subchronic toxicity studies summarized below are described in Table 10. No new repeated-dose dermal, oral, or inhalation toxicity data were available for PPG-3 Butyl Ether. Appropriate read-across materials were identified for dermal subchronic toxicity, oral short-term and subchronic toxicity, and short-term inhalation toxicity testing, and those data are included in this table. In dermal studies, effects on rabbit skin...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_018"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/d |
rat |
oral |
- |
developmental toxicity |
{"citation":"2; 1; 0","dose":"Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied...","effect":"y Studies PPG-2 Butyl Ether when dermally applied was nontoxic to pregnant rats and was non-teratogenic at doses up to 1.0 mL/ kg/d.1 The developmental and reproductive toxicity (DART) studies summarized below are described in Table 11. Ap- propriate read-across materials were identified for dermal and oral DART testing, and those data are included in this table. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation).9,10,17 Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2- ol was not embryotoxic, fetotoxic, or teratogenic in rats.9-11 No test-article related adverse developmental or repro- ductive effects were observed in rats dosed by gavage (days 7– 16 of gestation) with up to 1000 mg/kg Buteth-3.31 No effects on reproducti...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_020"} |
| CIR_vision_codex |
NOAEL |
=0 |
mg/ m3 |
rat |
oral |
- |
developmental toxicity |
{"citation":"1; 450; (2","dose":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg.","effect":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg. A NOAEL of 450 mg/kg was reported in rats fed a diet containing 1-(2-butoxy-1-methylethoxy)-propan-2-ol. In short-term inhalation studies (nine 6-h exposures) in rats, the NOAEL for Propylene Glycol Butyl Ether was 3785 mg/m3 and for 1-(2-butoxy-1-methylethoxy)-propan-2-ol was ≥200 mg/ m3. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but it did not produce reproductive or teratogenic effects (NOEL >1 mL/kg). Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation) or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation). Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2-ol was not em- bryotoxic, fetotoxic, or teratogenic in rats. No test-article related adverse developmental or re- productive effects were observed in rats dosed by gavage (days 7–16 of gestation) with up to 1000 mg/kg Buteth-3. No effects on reproduction were observed in ra...","page":36,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_021"} |
| CIR_vision_codex |
NOAEL |
=400 |
mg/kg bw |
rat |
oral |
14 days |
oral toxicity |
{"citation":"10; 6; 14","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights...","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference Propylene Glycol Butyl Ether 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in hig","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_001"} |
| CIR_vision_codex |
NOAEL |
=1000 |
mg/kg bw |
rat |
oral |
14 days |
repeated dose toxicity |
{"citation":"6; 14; 0, 100, 200","dose":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Buty...","effect":"er 6 Sprague- Dawley rats/ sex 14 days Propylene glycol 0, 100, 200, and 400 mg/kg bw In accord with OECD Guideline 407 dosed by gavage 1x daily NOAEL and LOAEL – 400 mg/kg bw -No signs of toxicity; no effect of body weights, organ weights, hematology, or clinical chemistry 9,13,37 [(butoxymethylethoxy) methylethoxy] propan-1-ol (read across to PPG-3 Butyl Ether) purity – 80.67% 5 Fischer 344 rats/sex 28 days Corn oil 0, 100, 350, or 1000 mg/kg bw In accord with OECD Guideline 407 dosed 1x/day, 5 days/wk by gavage NOAEL – 1000 mg/kg bw -No treatment-related effects on body wt, hematology parameters -Statistically significant increase in absolute and relative liver wts for mid- and high-dose animals, with increased hepatocellular size and “altered” staining of the cytoplasm in high dose animals 10 poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-men...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_002"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/day |
rat |
oral |
46 day |
repeated dose toxicity |
{"citation":"2; 12; 46","dose":"CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating a...","effect":",2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD rats/sex 46 day, males 53 days, females CMC 0, 20, 100, or 500 mg/ kg bw/day In accord with OECD Guideline 422 (combined repeated dose toxicity study with the reproduction/ develop-mental toxicity screening test) -Males dosed by gavage 1x/day for 14 days prior to and throughout mating, for 32 days -Females dosed 1x/day for 14 days prior to mating and continuing through breeding (2 wks), gestation (3 wks), and lactation (4 days) NOEL – 100 mg/kg bw/day, for clinical observations, higher absolute and relative liver wts, and increased incidence of liver and thyroid gland hypertrophy 500 mg/kg/day: treatment-related transient clinical observations in males and females during all phases of the study, including perioral soiling (all animals), muscle twitches (6/12 males, 11/12 females), uncoordinated gait (0/ 12 males, 6/12 females), and decreased activity (0/12 males, 3/12 females); all effects resolved within 1 h of dosing -No significant effects on body wt or body wt gain, feed consumption, hemato...","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_003"} |
| CIR_vision_codex |
NOAEL |
>750 |
mg/kg |
rat |
oral |
2-wk |
oral toxicity |
{"citation":"11; 1; (2","dose":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- p...","effect":"nt effects on body wt or body wt gain, feed consumption, hematology, clinical chemistry, urinalysis 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 6 Sprague- Dawley rats/ sex 2 wks Propylene glycol 0, 100, 200, or 400 mg/kg bw In accord with OECD guideline 407; by gavage NOAEL – 400 mg/kg 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Sprague- Dawley rats/ sex 2-wk In feed 0, 250, 500, or 750 mg/kg bw In accord with OECD guideline 407; feed study NOAEL – >750 mg/kg 9 (continued) 22S International Journal of Toxicology 41(Supplement 1)","page":18,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_004"} |
| CIR_vision_codex |
NOAEL |
=3244 |
mg/m3 |
rat |
inhalation |
11 days |
inhalation toxicity |
{"citation":"10; (98; 8","dose":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study:","effect":"mid- and high-dose males; histopathologic correlation with the higher kidney weights not evident in females 10 Inhalation Propylene Glycol Butyl Ether (98.8% pure) Main study: 10 Fischer 344 and 5 Sprague- Dawley rats/sex recovery: additional 10 sex/strain control and high dose 11 days None 0, 540, 1622, and 3244 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk; a 4-wk recovery group was used with each strain hematologic, clinical chemistry, and urinalysis parameters were examined NOAEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative...","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_005"} |
| CIR_vision_codex |
NOAEL |
>3785 |
mg/m3 |
rat |
- |
6 h/day |
NOAEL study |
{"citation":"344; (244; 13,49","dose":"6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al.","effect":"AEL 3244 mg/m3 Fischer 344 rats: statistically significant increase in absolute and relative liver (to body and to brain) weights (3244 mg/m3 males) and relative liver to body weights (244 mg/m3 females) without microscopic changes; low incidence of mild eye lesions 1622 and 3244 mg/m3 groups) Sprague Dawley rats: no exposure- related effects 13,49 Propylene Glycol Butyl Ether 5 Fischer 344 rats/ sex 2 wks None 0, 270, 1081, and 3785 mg/m3 In accord with OECD Guideline 412 9 whole body exposure; 6 h/day, 5 days/wk NOAEL and LOAEL >3785 mg/m3 -slightly increased relative liver weight in high dose males and females without microscopic effects 9,13,38 (continued) Fiume et al. 23S","page":19,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_006"} |
| CIR_vision_codex |
NOAEL |
=320 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"10; 1; (2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"Table 10. (continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammato","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_007"} |
| CIR_vision_codex |
NOAEL |
=200 |
mg/m3 |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"1; (2; 2","dose":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412;","effect":"(continued) Ingredient Animals/Group Study Duration Vehicle Dose/Concentration Procedure Results Reference 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 160, 320 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of t...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_008"} |
| CIR_vision_codex |
NOAEL |
=880 |
mg/kg bw |
rat |
inhalation |
SUBCHRONIC |
repeated dose toxicity |
{"citation":"320; 9; 1","dose":"9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application...","effect":"ose-only exposures NOAEL – 320 mg/m3 9 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 5 Fischer 344 rats/ sex 2 wks None 0, 200, 810, or 2010 mg/m3 In accord with OECD Guideline 412; 9–6/h nose-only exposures NOAEL – 200 mg/m3 LOAEL – 810 mg/m3 9 SUBCHRONIC TOXICITY STUDIES Dermal Propylene Glycol Butyl Ether 10 Wistar rats/sex 13 wks Propylene glycol 0, 88, 264, 880 mg/kg In accord with OECD Guideline 411 1 open 24-h application/day, 5 days/ wk; collars were used to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_009"} |
| CIR_vision_codex |
NOAEL |
=1.76 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"880; 9,13,36; 5","dose":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl...","effect":"d to prevent grooming NOAEL – 880 mg/kg bw -Irritation at all application sites, including controls; focal necrosis of the epidermis, crust formation, mild inflammatory changes, and acanthosis; difference in severity between treated and control animals was not significant -No clinical, gross, or microscopic signs of toxicity 9,13,36 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight...","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_010"} |
| CIR_vision_codex |
NOAEL |
=10 |
mg/kg bw/day |
rabbit |
dermal |
91 days |
NOAEL study |
{"citation":"5; 91; 2","dose":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 etha...","effect":"lene Glycol Butyl Ether 5 NZW rabbits/ sex 91 days Water 2 mL/kg bw In accord with OECD Guideline 411 1 open 7-h application/day, 5 days/ wk; collars were used to prevent grooming NOEL – 1.76 mg/kg bw/day -Mild to moderate irritation at the application site -No clinical signs of toxicity 13 Propylene Glycol Butyl Ether 5 NZW rabbits/ sex 13 wks 50/50 ethanol/ water 0, 10, 100, or 1000 mg/kg bw/ day; 2 mL/kg bw In accord with OECD Guideline 411 1 7-h application/day, 5 days/wk; collars were used to prevent grooming NOAEL/local skin irritation – 10 mg/kg bw/day LOAEL/local skin irritation – 100 mg/kg bw/day NOAEL/systemic toxicity – 1000 mg/kg bw/day -Dermal irritation in the mid and high dose groups; in the high dose group, severe erythema, slight to moderate edema, slight to moderate atonia, moderate desquamation, and slight to moderate fissuring. -Skin lesions were considered to be a direct, local effect from the solvents and the clipping procedure. -No clinical signs of toxicity 9 (continued) 24S International Journal of Toxicology 41(Supplement 1)","page":20,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_011"} |
| CIR_vision_codex |
NOAEL |
=91 |
mg/kg/day |
rat |
oral |
- |
oral toxicity |
{"citation":"35; 1; (2","dose":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats...","effect":"were used to prevent grooming -Slight erythema and severe erythema in the mid- and high-dose groups, respectively -No significant differences in body wt parameters or absolute organ or relative organ wts of the test animals compared to the vehicle control group 35 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 10 Wistar rats/sex 13 wks Propylene glycol 0, 91, 273, or 910 mg/ kg bw/day In accord with OECD Guideline 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_012"} |
| CIR_vision_codex |
NOAEL |
=350 |
mg/kg bw |
rat |
oral |
- |
oral toxicity |
{"citation":"411; 5; 91","dose":"5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups:","effect":"ine 411; 5 open applications/wk; animals wore collars to prevent ingestion NOAEL – 91 mg/kg/day LOAEL – 273 mg/kg/day (based on body weight -changes and increased neutrophil count) -Skin irritation at all test sites (including controls) 9 Oral Propylene Glycol Butyl Ether (99.4% pure) 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, and 1000 mg/kg bw recovery groups: 0 and 1000 mg/kg bw In accord with OECD Guideline 408 administered in drinking water recovery groups given untreated water for 4 wks following dosing NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg -Absolute and relative liver weights increased in high dose males ad absolute and relative kidney weights increased in high dose females with no accompanying histopathology -No changes in organs selected for examination, including the testes 9,13 PPG-3 Butyl Ether 10 Fischer 344 rats/sex 13 wks None 0, 100, 350, or 1000 mg/kg bw Administered in drinking water NOAEL – 350 mg/kg bw; LOAEL – 1000 mg/kg bw -Histopathological and organ weight alterations of liver and kidney (males) and liver (females) (details not provided) 30 (continu...","page":21,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_013"} |
| CIR_vision_codex |
NOAEL |
=450 |
mg/kg |
rat |
oral |
- |
oral toxicity |
{"citation":"10; 1; (2","dose":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl E...","effect":"males of all dose groups and females of the mid- and high-dose groups; absolute and relative kidney weights were increased in high-dose males mid- and high-dose females -Changes in hematology, clinical chemistry, and urinalysis parameters not considered toxicologically significant 10 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) 20 Sprague- dawley rats/ sex; additional 5 for interim sacrifice 13 wks In feed 0, 200, 450, or 1000 mg/kg bw In accord with OECD Guideline 408; feed study NOAEL – 450 mg/kg LOAEL – 1000 mg/kg -High-dose males: slight but statistically significant decrease in body wts, enlarged livers with histopathological changes, increased absolute, and relative liver weights; some changes in clinical chemistry corroborated liver changes -High-dose females: absolute and relative kidney weights were increased in high dose females with no accompanying histopathology 9 CMC, carboxymethylcellulose; LOAEL, lowest-observed adverse effect level; NOAEL, no-observed adverse effect level; NOEL, no-observed effect level; NZW, New Zealand White. 26S...","page":22,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_014"} |
| CIR_vision_codex |
NOAEL |
>100 |
mg/ kg bw/day |
rat |
- |
days 7-18 of gestation |
developmental toxicity |
{"citation":"9,11,17; (100; 19","dose":"19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic o...","effect":"s, uterus, kidneys, and liver wts comparable for test and control groups. -No test-article related visceral and skeletal malformations, anomalies, or variants 9,11,17 Propylene Glycol Butyl Ether (100% pure) Gravid NZW rabbits; 19/ test group, 17 control Water 0, 10, 40, and 100 mg/kg bw/ day In accord with OECD Guideline 414 6-h applications to a 10 cm x 20 cm shaved area of the dorsal trunk on days 7-18 of gestation; collars were used to prevent ingestion; animals were killed on day 29 of gestation Developmental NOEL – >100 mg/ kg bw/day -No maternal toxicity -No embryotoxic or teratogenic effects -Mild erythema in the high dose group occurred at a greater incidence and severity compared to other groups 9,10,17 PPG-2 Butyl Ether 20 gravid Wistar rats Not stated 0, 0.3, 1 mL/kg The test substance was applied dermally on days 6-16 of gestation; details were not provided Maternal and developmental NOEL – > 1 mL/kg -Local skin reactions observed in all treated animals; no signs of maternal toxicity -No reproductive or teratogenic effects 17 (continued) Fiume et al. 27S","page":23,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_015"} |
| CIR_vision_codex |
NOAEL |
=500 |
mg/kg/day |
rat |
oral |
- |
repeated dose toxicity |
{"citation":"9; 11; 1,2","dose":"CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the...","effect":"oups - Pre- and post-implantation loss, number of viable fetuses, and fetal weights and lengths comparable between treatment and control groups, no signs of developmental toxicity - Not embryotoxic, fetotoxic, or teratogenic 9-11 Oral poly[oxy(methyl-1,2- ethanediyl)],α- butyl-ω-hydroxy- (read across for PPG-n Butyl Ether) 12 Crj: CD (SD) rats/sex CMC 0, 20, 100, or 500 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10) NOEL for reproductive effects – 500 mg/kg/day no indication of reproductive toxicity at any dose; no adverse effects on prenatal/early neonatal growth and survival of the offspring 11 1-(2-butoxy-1- methylethoxy)- propan-2-ol (read across for PPG-n Butyl Ether) (99.34% pure) 12 Crl:CD (SD) rats/sex 0.5% methylcellulose 0, 100, 300, or 1000 mg/kg bw/ day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (described previously in Table 10 NOEL for reproductive effects – 1000 mg/kg/day - No treatment-related effects on any repr...","page":24,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_016"} |
| CIR_vision_codex |
NOAEL |
=0.047 |
g/kg/d |
rat |
oral |
14-d |
repeated dose toxicity |
{"citation":"(18; 7; 10","dose":"PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study.","effect":"eeding study involving dogs, no sta- tistically significant differences in the incidence of gross or microscopic lesions (18 tissues) between groups of animals fed PPG-7-Buteth-10 (0.004, 0.02, 0.1, and 0.5 g/kg/d) and control groups were observed. Similar results were reported for PPG-33-Buteth-45, following administration to groups of dogs at dietary doses of 0.023, 0.11, and 0.61 g/kg/day. PPG-2 Butyl Ether at a dose of 0.40 g/kg/day was nontoxic to rats during a 14-d feeding study. In 90-d feeding studies, the no-observed effect levels (NOELs) of PPG BE400, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_017"} |
| CIR_vision_codex |
NOAEL |
=0.5 |
g/kg/d |
rat |
oral |
5 d |
repeated dose toxicity |
{"citation":"0, 800, 910; 0; 047","dose":"When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d.","effect":"0, 800, 910, and 1020 were 0.047 g/kg/d, 0.16 to 0.67 g/kg/d, 0.25% of the diet, and 0.0625% of the diet, respectively. When rats were treated topically with PPG-2 Butyl Ether 5 d/wk for 13 wk, the dermal NOEL was 0.1 mL/kg/d, which was equivalent to a dose of 91 mg/kg/d. Doses of 0.25 g/kg/d 80% PPG-40 Butyl Ether, 2.0 g/kg/d 80% PPG-33 Butyl Ether, and 1.0 mL/kg/d PPG BE800 had no effect on mortality, weight change, or microscopic findings when applied to the skin of rabbits 5 d/ wk for 6 wk, but the 30-d dermal NOEL for PPG BE400 was <0.1 mL/kg/d. When dogs and rats were fed PPG BE800 and 910 for up to 2 yr, the NOELs were up to 0.5 g/kg/d.1 The short-term and subchronic toxicity studies summarized below are described in Table 10. No new repeated-dose dermal, oral, or inhalation toxicity data were available for PPG-3 Butyl Ether. Appropriate read-across materials were identified for dermal subchronic toxicity, oral short-term and subchronic toxicity, and short-term inhalation toxicity testing, and those data are included in this table. In dermal studies, effects on rabbit skin...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_018"} |
| CIR_vision_codex |
NOAEL |
=100 |
mg/kg bw/d |
rat |
oral |
- |
developmental toxicity |
{"citation":"2; 1; 0","dose":"Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied...","effect":"y Studies PPG-2 Butyl Ether when dermally applied was nontoxic to pregnant rats and was non-teratogenic at doses up to 1.0 mL/ kg/d.1 The developmental and reproductive toxicity (DART) studies summarized below are described in Table 11. Ap- propriate read-across materials were identified for dermal and oral DART testing, and those data are included in this table. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but not reproductive or teratogenic effects (NOEL >1 mL/kg).17 Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation)9,11,17 or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation).9,10,17 Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2- ol was not embryotoxic, fetotoxic, or teratogenic in rats.9-11 No test-article related adverse developmental or repro- ductive effects were observed in rats dosed by gavage (days 7– 16 of gestation) with up to 1000 mg/kg Buteth-3.31 No effects on reproducti...","page":33,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_020"} |
| CIR_vision_codex |
NOAEL |
=0 |
mg/ m3 |
rat |
oral |
- |
developmental toxicity |
{"citation":"1; 450; (2","dose":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg.","effect":"thoxy) methylethoxy]-propan-1-ol had a NOAEL of 1000 mg/kg. A NOAEL of 450 mg/kg was reported in rats fed a diet containing 1-(2-butoxy-1-methylethoxy)-propan-2-ol. In short-term inhalation studies (nine 6-h exposures) in rats, the NOAEL for Propylene Glycol Butyl Ether was 3785 mg/m3 and for 1-(2-butoxy-1-methylethoxy)-propan-2-ol was ≥200 mg/ m3. Dermal application of PPG-2 Butyl Ether to rats during days 6–16 of gestation produced local skin reactions, but it did not produce reproductive or teratogenic effects (NOEL >1 mL/kg). Dermally applied Propylene Glycol Butyl Ether was not em- bryotoxic or teratogenic to rats (≤1.0 mL/kg bw/d applied on days 6–16 of gestation) or rabbits (≤100 mg/kg bw/d applied on days 7–18 of gestation). Dermal application of up to 910 mg/kg bw/d 1-(2-butoxy-1-methylethoxy)-propan-2-ol was not em- bryotoxic, fetotoxic, or teratogenic in rats. No test-article related adverse developmental or re- productive effects were observed in rats dosed by gavage (days 7–16 of gestation) with up to 1000 mg/kg Buteth-3. No effects on reproduction were observed in ra...","page":36,"pdf":"PRS726.pdf","row_type":"noael_study","study_id":"PRS726_noael_021"} |