NOAEL Studies
Cosmetic Ingredient
Laureth-50 NOAEL Studies
INCI: LAURETH-50
CAS: 9002-92-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 88 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =0 | ppm | rat | oral | - | developmental toxicity | {"citation":"64; 145; 33","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"g/kg (rabbits); inhalation LC50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reac...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_001"} |
| CIR_vision_codex | NOAEL | =5000 | ppm | rat | oral | - | developmental toxicity | {"citation":"50; 64; 145","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reactions Important discussion it...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_002"} |
| CIR_vision_codex | NOAEL | =0.375 | % | rat | oral | 21 days | repeated dose toxicity | {"citation":"21; 6; 0","dose":"The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11.","effect":"he diet for 21 days. A group of 6 male and 6 female rats were used as the control group. With all test compounds, growth was decreased in the 0.75% and 1.5% groups; changes in plasma protein con- centration and organ weights were associated with this effect. The liver appeared to be the major target organ, but it was stated that changes seemed to be indicative of an adaptive response rather than a true adverse effect. The lowest observa- ble effect level (LOEL) was 0.75% in the diet for all the test compounds. The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11. Groups of Colworth Wistar rats, number per group not spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_003"} |
| CIR_vision_codex | NOAEL | =7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | {"citation":"0; 03; 1","dose":"The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7.","effect":"spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed 0.25%, 0.5%, and 1.0% of the test materials. Upon microscopic examination, hepatocyte enlargement was noted in the livers. No effects were observed in reproductive organs. The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7. C14-15AE7 was fed to groups of 6 male and 6 female Wistar rats at concentrations of 300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relat...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_004"} |
| CIR_vision_codex | NOAEL | =300 | ppm | rat | oral | 90 days | repeated dose toxicity | {"citation":"300; 10; 000","dose":"300 to 10 000 ppm of active ingredient for 90 days.","effect":"300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relative spleen to body weight was increased in males of the 10 000 ppm group. Microscopically, no compound-related effects were seen at any dose level. The dietary NOAEL was 300 ppm, corresponding to 15 mg/kg bw C14-15AE7. Fiume et al 223S","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_005"} |
| CIR_vision_codex | NOAEL | =1 | % | rat | oral | 90-day | repeated dose toxicity | {"citation":"90; 20; 0","dose":"The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females.","effect":"In another 90-day study, C14-15AE7 was also fed to groups of 20 male and 20 female albino rats at concentrations of 0.1%, 0.5%, and 1% in the diet. Five rats/gender were killed for necropsy on day 28. No treatment-related changes in body weights, feed intake, organ weights, clinical chemistry, or hematology were observed. The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females. In a 2-year study, rats, number per group not specified, were fed 0.1%, 0.5%, and 1% C12-13AE6.5 and C14-15AE7 in the diet. Reduced feed consumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- ca","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_006"} |
| CIR_vision_codex | NOAEL | =0.1 | % | rat | oral | 2 years | oral toxicity | {"citation":"0; 5; 1","dose":"The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d.","effect":"nsumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- carditis was greater in treated males than in controls. No other treatment-related lesions were observed. The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, correspondi...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_007"} |
| CIR_vision_codex | NOAEL | =190 | mg/kg | rat | oral | 2 years | oral toxicity | {"citation":"50; 0; 1","dose":"to 50 mg/kg per bw/d.","effect":"to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, corresponding to 190 and 162 mg/kg per bw/d for female and male rats, respectively. Deceths Groups of 5 female NZW rabbits were dosed orally by gavage with 2 mL/kg of 0.12, 0.25, 0.50, 0.75, or 1.0 g/kg deceth (avg chain length not specified) for 13 days.42 The negative control group was dosed with distilled water. The deaths that occurred were 1 rabbit dosed with 0.12 g/kg (day 8; thought to be gavage error); all 5 rabbits dosed with 0.25 g/kg (days 2-12); 4 rabbits dosed with 0.5 g/kg (days 2-14); 4 rabbits dosed with 0.75 g/kg (days 2-14); and all 5 ra...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_008"} |
| CIR_vision_codex | NOAEL | =1.6 | g/kg | rat | oral | 14 days | oral toxicity | {"citation":"0, 0; 75, 1; 6, 3","dose":"equently in the higher dose groups.","effect":"equently in the higher dose groups. Severe body weight loss was noted in the highest dose group, and slight to moderate body weight loss was observed in the other groups. Feed consumption was sig- nificantly decreased at some point for all groups. PEG Methyl Ethers Sprague-Dawley rats (number/gender/group not specified) were given 0, 0.75, 1.6, 3.9, and 8.0 g/kg per d PEG-3 methyl ether in the drinking water for 14 days.20 PEG-3 methyl ether was mildly to moderately toxic at 4 g/kg and severely toxic at \u00028 g/kg. A NOAEL of 1.6 g/kg per d was assigned. Groups of 15 male and15 female Sprague-Dawley CD rats were given drinking water containing target doses of 0, 400, 1200, and 4000 mg/kg per d PEG-3 methyl ether for 91 days.20 One female of the high-dose group died during the study. No treatment-related clinical signs of toxicity, alterations in func- tional observational battery, or gross microscopic lesions in the nervous system were found. Statistically significant increases in absolute liver weights were observed in males of the high- dose group; increased relative liver to body...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_009"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"10; 2; (0","dose":"Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females.","effect":"moderate or marked vacuolization. Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females. Treatment-related mild to moderate degeneration and/or minimal to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control gr...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_010"} |
| CIR_vision_codex | NOAEL | =1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"2; (0; 02","dose":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group.","effect":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control group of 24 males and 24 females was given untreated feed. All the animals were killed at the termination of dosing. Treatment-related clinical signs were not observed during the...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_011"} |
| CIR_vision_codex | NOAEL | =4000 | mg/kg | rabbit | dermal | 12-day | NOAEL study | {"citation":"0; 3; 6","dose":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period.","effect":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period. No treatment-related adverse effects were observed. Slight scabbing or crusting was noted at the test site of a few mid- or high-dose males and females. Clinical chem- istry and hematological and urinalysis values that were statis- tically significantly different from control values were reported, but these effects were not considered by the research- ers to be treatment related. The NOAEL was determined to be 4000 mg/kg per d for this study. A group of 5 male and 5 female NZW rabbits was used to determine the dermal toxicity of PEG-3 methyl ether.20,38 A dose of 1000 mg/kg per d was applied neatly to the shaved skin (size of test area not specified) on the back of each animal, 6 h/ d, 5 d/week for 3 weeks, under an occlusive covering; the animals were restrained during dosing. Six hours after applica- tion, the site was rinsed. The negative control group of 10 animals was sham treated. The test sites were scored for dermal irritation immediately pri...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_012"} |
| CIR_vision_codex | NOAEL | <1200 | mg/kg bw | rat | dermal | 14-day | NOAEL study | {"citation":"12; 5; 1","dose":"Additional groups of 5 rats/gender per dose were used for interim evaluations.","effect":"niformly spread on a 12 cm2 area under a semiocclu- sive covering. Additional groups of 5 rats/gender per dose were used for interim evaluations. There were no indications of sys- temic toxicity, and the researchers did not consider testicular effects in 1 high-dose and 1 mid-dose male to be test article related. (Dermal effects were not described.) The researchers assigned a NOAEL of 4000 mg/kg per bw/d PEG-3 methyl ether. However, the EPA reviewed that data and, based on testicular effects in 2 males, assigned a NOAEL of >400 and<1200 mg/kg bw. The dermal toxicity of PEG-7 methyl ether was evaluated in 14-day and 28-day studies using CD(SD)BR rats.21 In the 14- day study, 10 males and 10 females were dosed dermally with 5000 mg/kg undiluted PEG-7 methyl ether. The test site was clipped of hair, and applications were made 5 days/week. The application site was not occluded, but a collar was placed on the animals just prior to dosing until study termination. Controls were handled similarly, except no applications were made. In the 28-day study, groups of 15 male rats were dosed der...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_013"} |
| CIR_vision_codex | NOAEL | =25 | % | rat | - | - | reproductive toxicity | {"citation":"5; 10; 25","dose":"Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose.","effect":"mated. For both generations, the application sites were evaluated for irritation. The male rats of both generations were killed following mating. Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose. There was no mortality in the F0 generations, and deaths that did occur in the F1 generation were not attributed to treatment. No irritation was observed for any of the animals, but dry flaking skin was observed in the 10% and 25% dose groups. For effects on body weight, 10% was a no-effect level and 25% C9-11 pareth 6 caused a minimal decrease in body weights over the study. There were no compound-related effects on maternal body weights in any test group. No toxicologically significant 232S International Journal of Toxicology 31(Supplement 2)","page":64,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_014"} |
| CIR_vision_codex | NOAEL | >50 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"9; 19; 25","dose":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation.","effect":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation. In the 100 and 200 mg/kg groups, ataxia and a slight decrease in body weights were the evidence of maternal toxicity. No effects on reproductive parameters were noted. During the study, 9 con- trol animals and 31 test animals died. Based on maternal toxi- city, the NOAEL was >50 mg/kg per bw/d. Groups of 25 male and 25 female CD rats were used to evaluate the reproductive toxicity of C14-15AE7 in a 2- generation study. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No co...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_015"} |
| CIR_vision_codex | NOAEL | >0.5 | % | rat | oral | - | developmental toxicity | {"citation":"0; 05; 1","dose":"The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d).","effect":"dy. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No compound-related differences in fertility, gestation, or viability indices were observed, and the NOAEL for repro- duction with dietary administration of C14-15AE7 was >0.5% (equivalent to 250 mg/kg per bw/d). In addition, effects on the FC generation, that is offspring from the third mating of the F0 and F1 parenteral generation, were examined. Gravid female rats were necropsied and exam- ined on either day 13 or day 21 of gestation. Differences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weig...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_016"} |
| CIR_vision_codex | NOAEL | >250 | mg/ kg | rat | oral | - | developmental toxicity | {"citation":"250; 50; 10","dose":"Parental and offspring weight gain was reduced in the 250 mg/kg group.","effect":"w/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a statistically significant decrease in mean fetal liver weights was observed. None of these effects were considered test article related. The NOAEL for reproduction was >250 mg/ kg per bw/d, and the NOAELs for maternal and developmental toxicity were 50 mg/kg per bw/d C12AE6 in the diet. PEG methyl ethers. In a modified Chernoff-Kavlock test, groups of 10 gravid Alpk:AP Wistar rats were dosed daily by gavage with 250 or 1000 mg/kg PEG-3 methyl ether at a vol- ume of 10 mL/kg on days 7 to 16 of gestation.38 The negative control group of 10 gravid rats was given 10 mL/kg water and the 2 positive control groups were dosed with 50 and 250 mg/ kg methoxyethanol. The dams were allowed to deliver their pups. Treatmen...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_018"} |
| CIR_vision_codex | NOAEL | =1250 | mg/kg | rat | - | - | developmental toxicity | {"citation":"3; 625","dose":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group.","effect":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group. Fetal body weights were statistically significantly decreased in the 2500 and 5000 mg/ kg group and slightly decreased in the 1250 mg/kg group. The incidence of gross external, soft tissue, or skeletal fetal mal- formations was not affected at any dose level. Doses of \u00021250 mg/kg PEG-3 methyl ether did cause significant increases in reversible delayed ossification. The maternal and developmen- tal no-observable effect levels (NOELs) for rats were 625 mg/ Fiume et al 235S","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_019"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"rnal soft tissue, or skeletal malformations. Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_020"} |
| CIR_vision_codex | NOAEL | =1500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_021"} |
| CIR_vision_codex | NOAEL | =1650 | mg/kg bw | rat | - | - | developmental toxicity | {"citation":"20; 4; 1","dose":"In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals.","effect":"toxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals. Kidney weights of maternal rats were statistically significantly increased in the high-dose group compared to controls. A maternal NOAEL of 1650 mg/kg bw was assigned. The length of gestation was statistically significantly increased in animals of the high-dose group; however, the researchers found the biological significance of this questionable. Body weights of female pups of the mid- and high-dose groups and male pups of the high-dose group were significantly greater than controls at PND 0. At PND 68, male pups of the high-dose group weighed statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- an...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_022"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | - | - | - | NOAEL study | {"citation":"300; (3; 333","dose":"Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy.","effect":"d statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy. Behavioral evaluations did not find any dose-related effects on motor activity or active avoidance. A significant effect on auditory startle response parameters was noted; the significance of this finding was not clear to the researchers. The researchers assigned an NOEL of 300 mg/kg for offspring, while EPA assigned an NOAEL of 300 mg/kg for teratogenicity. Genotoxicity Laureths Laureth (chain length not specified) was tested in a number of genotoxicity studies. In an Ames study, laureth (3-333 mg/ plate) was negative with and without activation.70 In a standard transformation assay with BALB/c-3T3 cells, laureth (tested at 0.00132-0.0417 and 0.00625-0.0250 mmol/L) was inactive.71 Using Chinese hamster ovary (CHO) cells, laureth did not induce sister chromatid exchanges (concentrations of 3.08- 10.8 mg/mL with or 0.308-3.08 mg/mL w...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_023"} |
| CIR_vision_codex | NOAEL | =0 | ppm | rat | oral | - | developmental toxicity | {"citation":"64; 145; 33","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"g/kg (rabbits); inhalation LC50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reac...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_001"} |
| CIR_vision_codex | NOAEL | =5000 | ppm | rat | oral | - | developmental toxicity | {"citation":"50; 64; 145","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reactions Important discussion it...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_002"} |
| CIR_vision_codex | NOAEL | =0.375 | % | rat | oral | 21 days | repeated dose toxicity | {"citation":"21; 6; 0","dose":"The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11.","effect":"he diet for 21 days. A group of 6 male and 6 female rats were used as the control group. With all test compounds, growth was decreased in the 0.75% and 1.5% groups; changes in plasma protein con- centration and organ weights were associated with this effect. The liver appeared to be the major target organ, but it was stated that changes seemed to be indicative of an adaptive response rather than a true adverse effect. The lowest observa- ble effect level (LOEL) was 0.75% in the diet for all the test compounds. The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11. Groups of Colworth Wistar rats, number per group not spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_003"} |
| CIR_vision_codex | NOAEL | =7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | {"citation":"0; 03; 1","dose":"The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7.","effect":"spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed 0.25%, 0.5%, and 1.0% of the test materials. Upon microscopic examination, hepatocyte enlargement was noted in the livers. No effects were observed in reproductive organs. The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7. C14-15AE7 was fed to groups of 6 male and 6 female Wistar rats at concentrations of 300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relat...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_004"} |
| CIR_vision_codex | NOAEL | =300 | ppm | rat | oral | 90 days | repeated dose toxicity | {"citation":"300; 10; 000","dose":"300 to 10 000 ppm of active ingredient for 90 days.","effect":"300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relative spleen to body weight was increased in males of the 10 000 ppm group. Microscopically, no compound-related effects were seen at any dose level. The dietary NOAEL was 300 ppm, corresponding to 15 mg/kg bw C14-15AE7. Fiume et al 223S","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_005"} |
| CIR_vision_codex | NOAEL | =1 | % | rat | oral | 90-day | repeated dose toxicity | {"citation":"90; 20; 0","dose":"The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females.","effect":"In another 90-day study, C14-15AE7 was also fed to groups of 20 male and 20 female albino rats at concentrations of 0.1%, 0.5%, and 1% in the diet. Five rats/gender were killed for necropsy on day 28. No treatment-related changes in body weights, feed intake, organ weights, clinical chemistry, or hematology were observed. The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females. In a 2-year study, rats, number per group not specified, were fed 0.1%, 0.5%, and 1% C12-13AE6.5 and C14-15AE7 in the diet. Reduced feed consumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- ca","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_006"} |
| CIR_vision_codex | NOAEL | =0.1 | % | rat | oral | 2 years | oral toxicity | {"citation":"0; 5; 1","dose":"The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d.","effect":"nsumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- carditis was greater in treated males than in controls. No other treatment-related lesions were observed. The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, correspondi...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_007"} |
| CIR_vision_codex | NOAEL | =190 | mg/kg | rat | oral | 2 years | oral toxicity | {"citation":"50; 0; 1","dose":"to 50 mg/kg per bw/d.","effect":"to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, corresponding to 190 and 162 mg/kg per bw/d for female and male rats, respectively. Deceths Groups of 5 female NZW rabbits were dosed orally by gavage with 2 mL/kg of 0.12, 0.25, 0.50, 0.75, or 1.0 g/kg deceth (avg chain length not specified) for 13 days.42 The negative control group was dosed with distilled water. The deaths that occurred were 1 rabbit dosed with 0.12 g/kg (day 8; thought to be gavage error); all 5 rabbits dosed with 0.25 g/kg (days 2-12); 4 rabbits dosed with 0.5 g/kg (days 2-14); 4 rabbits dosed with 0.75 g/kg (days 2-14); and all 5 ra...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_008"} |
| CIR_vision_codex | NOAEL | =1.6 | g/kg | rat | oral | 14 days | oral toxicity | {"citation":"0, 0; 75, 1; 6, 3","dose":"equently in the higher dose groups.","effect":"equently in the higher dose groups. Severe body weight loss was noted in the highest dose group, and slight to moderate body weight loss was observed in the other groups. Feed consumption was sig- nificantly decreased at some point for all groups. PEG Methyl Ethers Sprague-Dawley rats (number/gender/group not specified) were given 0, 0.75, 1.6, 3.9, and 8.0 g/kg per d PEG-3 methyl ether in the drinking water for 14 days.20 PEG-3 methyl ether was mildly to moderately toxic at 4 g/kg and severely toxic at \u00028 g/kg. A NOAEL of 1.6 g/kg per d was assigned. Groups of 15 male and15 female Sprague-Dawley CD rats were given drinking water containing target doses of 0, 400, 1200, and 4000 mg/kg per d PEG-3 methyl ether for 91 days.20 One female of the high-dose group died during the study. No treatment-related clinical signs of toxicity, alterations in func- tional observational battery, or gross microscopic lesions in the nervous system were found. Statistically significant increases in absolute liver weights were observed in males of the high- dose group; increased relative liver to body...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_009"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"10; 2; (0","dose":"Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females.","effect":"moderate or marked vacuolization. Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females. Treatment-related mild to moderate degeneration and/or minimal to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control gr...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_010"} |
| CIR_vision_codex | NOAEL | =1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"2; (0; 02","dose":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group.","effect":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control group of 24 males and 24 females was given untreated feed. All the animals were killed at the termination of dosing. Treatment-related clinical signs were not observed during the...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_011"} |
| CIR_vision_codex | NOAEL | =4000 | mg/kg | rabbit | dermal | 12-day | NOAEL study | {"citation":"0; 3; 6","dose":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period.","effect":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period. No treatment-related adverse effects were observed. Slight scabbing or crusting was noted at the test site of a few mid- or high-dose males and females. Clinical chem- istry and hematological and urinalysis values that were statis- tically significantly different from control values were reported, but these effects were not considered by the research- ers to be treatment related. The NOAEL was determined to be 4000 mg/kg per d for this study. A group of 5 male and 5 female NZW rabbits was used to determine the dermal toxicity of PEG-3 methyl ether.20,38 A dose of 1000 mg/kg per d was applied neatly to the shaved skin (size of test area not specified) on the back of each animal, 6 h/ d, 5 d/week for 3 weeks, under an occlusive covering; the animals were restrained during dosing. Six hours after applica- tion, the site was rinsed. The negative control group of 10 animals was sham treated. The test sites were scored for dermal irritation immediately pri...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_012"} |
| CIR_vision_codex | NOAEL | <1200 | mg/kg bw | rat | dermal | 14-day | NOAEL study | {"citation":"12; 5; 1","dose":"Additional groups of 5 rats/gender per dose were used for interim evaluations.","effect":"niformly spread on a 12 cm2 area under a semiocclu- sive covering. Additional groups of 5 rats/gender per dose were used for interim evaluations. There were no indications of sys- temic toxicity, and the researchers did not consider testicular effects in 1 high-dose and 1 mid-dose male to be test article related. (Dermal effects were not described.) The researchers assigned a NOAEL of 4000 mg/kg per bw/d PEG-3 methyl ether. However, the EPA reviewed that data and, based on testicular effects in 2 males, assigned a NOAEL of >400 and<1200 mg/kg bw. The dermal toxicity of PEG-7 methyl ether was evaluated in 14-day and 28-day studies using CD(SD)BR rats.21 In the 14- day study, 10 males and 10 females were dosed dermally with 5000 mg/kg undiluted PEG-7 methyl ether. The test site was clipped of hair, and applications were made 5 days/week. The application site was not occluded, but a collar was placed on the animals just prior to dosing until study termination. Controls were handled similarly, except no applications were made. In the 28-day study, groups of 15 male rats were dosed der...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_013"} |
| CIR_vision_codex | NOAEL | =25 | % | rat | - | - | reproductive toxicity | {"citation":"5; 10; 25","dose":"Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose.","effect":"mated. For both generations, the application sites were evaluated for irritation. The male rats of both generations were killed following mating. Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose. There was no mortality in the F0 generations, and deaths that did occur in the F1 generation were not attributed to treatment. No irritation was observed for any of the animals, but dry flaking skin was observed in the 10% and 25% dose groups. For effects on body weight, 10% was a no-effect level and 25% C9-11 pareth 6 caused a minimal decrease in body weights over the study. There were no compound-related effects on maternal body weights in any test group. No toxicologically significant 232S International Journal of Toxicology 31(Supplement 2)","page":64,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_014"} |
| CIR_vision_codex | NOAEL | >50 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"9; 19; 25","dose":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation.","effect":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation. In the 100 and 200 mg/kg groups, ataxia and a slight decrease in body weights were the evidence of maternal toxicity. No effects on reproductive parameters were noted. During the study, 9 con- trol animals and 31 test animals died. Based on maternal toxi- city, the NOAEL was >50 mg/kg per bw/d. Groups of 25 male and 25 female CD rats were used to evaluate the reproductive toxicity of C14-15AE7 in a 2- generation study. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No co...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_015"} |
| CIR_vision_codex | NOAEL | >0.5 | % | rat | oral | - | developmental toxicity | {"citation":"0; 05; 1","dose":"The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d).","effect":"dy. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No compound-related differences in fertility, gestation, or viability indices were observed, and the NOAEL for repro- duction with dietary administration of C14-15AE7 was >0.5% (equivalent to 250 mg/kg per bw/d). In addition, effects on the FC generation, that is offspring from the third mating of the F0 and F1 parenteral generation, were examined. Gravid female rats were necropsied and exam- ined on either day 13 or day 21 of gestation. Differences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weig...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_016"} |
| CIR_vision_codex | NOAEL | >250 | mg/ kg | rat | oral | - | developmental toxicity | {"citation":"250; 50; 10","dose":"Parental and offspring weight gain was reduced in the 250 mg/kg group.","effect":"w/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a statistically significant decrease in mean fetal liver weights was observed. None of these effects were considered test article related. The NOAEL for reproduction was >250 mg/ kg per bw/d, and the NOAELs for maternal and developmental toxicity were 50 mg/kg per bw/d C12AE6 in the diet. PEG methyl ethers. In a modified Chernoff-Kavlock test, groups of 10 gravid Alpk:AP Wistar rats were dosed daily by gavage with 250 or 1000 mg/kg PEG-3 methyl ether at a vol- ume of 10 mL/kg on days 7 to 16 of gestation.38 The negative control group of 10 gravid rats was given 10 mL/kg water and the 2 positive control groups were dosed with 50 and 250 mg/ kg methoxyethanol. The dams were allowed to deliver their pups. Treatmen...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_018"} |
| CIR_vision_codex | NOAEL | =1250 | mg/kg | rat | - | - | developmental toxicity | {"citation":"3; 625","dose":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group.","effect":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group. Fetal body weights were statistically significantly decreased in the 2500 and 5000 mg/ kg group and slightly decreased in the 1250 mg/kg group. The incidence of gross external, soft tissue, or skeletal fetal mal- formations was not affected at any dose level. Doses of \u00021250 mg/kg PEG-3 methyl ether did cause significant increases in reversible delayed ossification. The maternal and developmen- tal no-observable effect levels (NOELs) for rats were 625 mg/ Fiume et al 235S","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_019"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"rnal soft tissue, or skeletal malformations. Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_020"} |
| CIR_vision_codex | NOAEL | =1500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_021"} |
| CIR_vision_codex | NOAEL | =1650 | mg/kg bw | rat | - | - | developmental toxicity | {"citation":"20; 4; 1","dose":"In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals.","effect":"toxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals. Kidney weights of maternal rats were statistically significantly increased in the high-dose group compared to controls. A maternal NOAEL of 1650 mg/kg bw was assigned. The length of gestation was statistically significantly increased in animals of the high-dose group; however, the researchers found the biological significance of this questionable. Body weights of female pups of the mid- and high-dose groups and male pups of the high-dose group were significantly greater than controls at PND 0. At PND 68, male pups of the high-dose group weighed statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- an...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_022"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | - | - | - | NOAEL study | {"citation":"300; (3; 333","dose":"Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy.","effect":"d statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy. Behavioral evaluations did not find any dose-related effects on motor activity or active avoidance. A significant effect on auditory startle response parameters was noted; the significance of this finding was not clear to the researchers. The researchers assigned an NOEL of 300 mg/kg for offspring, while EPA assigned an NOAEL of 300 mg/kg for teratogenicity. Genotoxicity Laureths Laureth (chain length not specified) was tested in a number of genotoxicity studies. In an Ames study, laureth (3-333 mg/ plate) was negative with and without activation.70 In a standard transformation assay with BALB/c-3T3 cells, laureth (tested at 0.00132-0.0417 and 0.00625-0.0250 mmol/L) was inactive.71 Using Chinese hamster ovary (CHO) cells, laureth did not induce sister chromatid exchanges (concentrations of 3.08- 10.8 mg/mL with or 0.308-3.08 mg/mL w...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_023"} |
| CIR_vision_codex | NOAEL | =0 | ppm | rat | oral | - | developmental toxicity | {"citation":"64; 145; 33","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"g/kg (rabbits); inhalation LC50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reac...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_001"} |
| CIR_vision_codex | NOAEL | =5000 | ppm | rat | oral | - | developmental toxicity | {"citation":"50; 64; 145","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reactions Important discussion it...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_002"} |
| CIR_vision_codex | NOAEL | =0.375 | % | rat | oral | 21 days | repeated dose toxicity | {"citation":"21; 6; 0","dose":"The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11.","effect":"he diet for 21 days. A group of 6 male and 6 female rats were used as the control group. With all test compounds, growth was decreased in the 0.75% and 1.5% groups; changes in plasma protein con- centration and organ weights were associated with this effect. The liver appeared to be the major target organ, but it was stated that changes seemed to be indicative of an adaptive response rather than a true adverse effect. The lowest observa- ble effect level (LOEL) was 0.75% in the diet for all the test compounds. The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11. Groups of Colworth Wistar rats, number per group not spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_003"} |
| CIR_vision_codex | NOAEL | =7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | {"citation":"0; 03; 1","dose":"The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7.","effect":"spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed 0.25%, 0.5%, and 1.0% of the test materials. Upon microscopic examination, hepatocyte enlargement was noted in the livers. No effects were observed in reproductive organs. The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7. C14-15AE7 was fed to groups of 6 male and 6 female Wistar rats at concentrations of 300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relat...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_004"} |
| CIR_vision_codex | NOAEL | =300 | ppm | rat | oral | 90 days | repeated dose toxicity | {"citation":"300; 10; 000","dose":"300 to 10 000 ppm of active ingredient for 90 days.","effect":"300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relative spleen to body weight was increased in males of the 10 000 ppm group. Microscopically, no compound-related effects were seen at any dose level. The dietary NOAEL was 300 ppm, corresponding to 15 mg/kg bw C14-15AE7. Fiume et al 223S","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_005"} |
| CIR_vision_codex | NOAEL | =1 | % | rat | oral | 90-day | repeated dose toxicity | {"citation":"90; 20; 0","dose":"The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females.","effect":"In another 90-day study, C14-15AE7 was also fed to groups of 20 male and 20 female albino rats at concentrations of 0.1%, 0.5%, and 1% in the diet. Five rats/gender were killed for necropsy on day 28. No treatment-related changes in body weights, feed intake, organ weights, clinical chemistry, or hematology were observed. The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females. In a 2-year study, rats, number per group not specified, were fed 0.1%, 0.5%, and 1% C12-13AE6.5 and C14-15AE7 in the diet. Reduced feed consumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- ca","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_006"} |
| CIR_vision_codex | NOAEL | =0.1 | % | rat | oral | 2 years | oral toxicity | {"citation":"0; 5; 1","dose":"The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d.","effect":"nsumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- carditis was greater in treated males than in controls. No other treatment-related lesions were observed. The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, correspondi...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_007"} |
| CIR_vision_codex | NOAEL | =190 | mg/kg | rat | oral | 2 years | oral toxicity | {"citation":"50; 0; 1","dose":"to 50 mg/kg per bw/d.","effect":"to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, corresponding to 190 and 162 mg/kg per bw/d for female and male rats, respectively. Deceths Groups of 5 female NZW rabbits were dosed orally by gavage with 2 mL/kg of 0.12, 0.25, 0.50, 0.75, or 1.0 g/kg deceth (avg chain length not specified) for 13 days.42 The negative control group was dosed with distilled water. The deaths that occurred were 1 rabbit dosed with 0.12 g/kg (day 8; thought to be gavage error); all 5 rabbits dosed with 0.25 g/kg (days 2-12); 4 rabbits dosed with 0.5 g/kg (days 2-14); 4 rabbits dosed with 0.75 g/kg (days 2-14); and all 5 ra...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_008"} |
| CIR_vision_codex | NOAEL | =1.6 | g/kg | rat | oral | 14 days | oral toxicity | {"citation":"0, 0; 75, 1; 6, 3","dose":"equently in the higher dose groups.","effect":"equently in the higher dose groups. Severe body weight loss was noted in the highest dose group, and slight to moderate body weight loss was observed in the other groups. Feed consumption was sig- nificantly decreased at some point for all groups. PEG Methyl Ethers Sprague-Dawley rats (number/gender/group not specified) were given 0, 0.75, 1.6, 3.9, and 8.0 g/kg per d PEG-3 methyl ether in the drinking water for 14 days.20 PEG-3 methyl ether was mildly to moderately toxic at 4 g/kg and severely toxic at \u00028 g/kg. A NOAEL of 1.6 g/kg per d was assigned. Groups of 15 male and15 female Sprague-Dawley CD rats were given drinking water containing target doses of 0, 400, 1200, and 4000 mg/kg per d PEG-3 methyl ether for 91 days.20 One female of the high-dose group died during the study. No treatment-related clinical signs of toxicity, alterations in func- tional observational battery, or gross microscopic lesions in the nervous system were found. Statistically significant increases in absolute liver weights were observed in males of the high- dose group; increased relative liver to body...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_009"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"10; 2; (0","dose":"Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females.","effect":"moderate or marked vacuolization. Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females. Treatment-related mild to moderate degeneration and/or minimal to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control gr...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_010"} |
| CIR_vision_codex | NOAEL | =1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"2; (0; 02","dose":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group.","effect":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control group of 24 males and 24 females was given untreated feed. All the animals were killed at the termination of dosing. Treatment-related clinical signs were not observed during the...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_011"} |
| CIR_vision_codex | NOAEL | =4000 | mg/kg | rabbit | dermal | 12-day | NOAEL study | {"citation":"0; 3; 6","dose":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period.","effect":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period. No treatment-related adverse effects were observed. Slight scabbing or crusting was noted at the test site of a few mid- or high-dose males and females. Clinical chem- istry and hematological and urinalysis values that were statis- tically significantly different from control values were reported, but these effects were not considered by the research- ers to be treatment related. The NOAEL was determined to be 4000 mg/kg per d for this study. A group of 5 male and 5 female NZW rabbits was used to determine the dermal toxicity of PEG-3 methyl ether.20,38 A dose of 1000 mg/kg per d was applied neatly to the shaved skin (size of test area not specified) on the back of each animal, 6 h/ d, 5 d/week for 3 weeks, under an occlusive covering; the animals were restrained during dosing. Six hours after applica- tion, the site was rinsed. The negative control group of 10 animals was sham treated. The test sites were scored for dermal irritation immediately pri...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_012"} |
| CIR_vision_codex | NOAEL | <1200 | mg/kg bw | rat | dermal | 14-day | NOAEL study | {"citation":"12; 5; 1","dose":"Additional groups of 5 rats/gender per dose were used for interim evaluations.","effect":"niformly spread on a 12 cm2 area under a semiocclu- sive covering. Additional groups of 5 rats/gender per dose were used for interim evaluations. There were no indications of sys- temic toxicity, and the researchers did not consider testicular effects in 1 high-dose and 1 mid-dose male to be test article related. (Dermal effects were not described.) The researchers assigned a NOAEL of 4000 mg/kg per bw/d PEG-3 methyl ether. However, the EPA reviewed that data and, based on testicular effects in 2 males, assigned a NOAEL of >400 and<1200 mg/kg bw. The dermal toxicity of PEG-7 methyl ether was evaluated in 14-day and 28-day studies using CD(SD)BR rats.21 In the 14- day study, 10 males and 10 females were dosed dermally with 5000 mg/kg undiluted PEG-7 methyl ether. The test site was clipped of hair, and applications were made 5 days/week. The application site was not occluded, but a collar was placed on the animals just prior to dosing until study termination. Controls were handled similarly, except no applications were made. In the 28-day study, groups of 15 male rats were dosed der...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_013"} |
| CIR_vision_codex | NOAEL | =25 | % | rat | - | - | reproductive toxicity | {"citation":"5; 10; 25","dose":"Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose.","effect":"mated. For both generations, the application sites were evaluated for irritation. The male rats of both generations were killed following mating. Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose. There was no mortality in the F0 generations, and deaths that did occur in the F1 generation were not attributed to treatment. No irritation was observed for any of the animals, but dry flaking skin was observed in the 10% and 25% dose groups. For effects on body weight, 10% was a no-effect level and 25% C9-11 pareth 6 caused a minimal decrease in body weights over the study. There were no compound-related effects on maternal body weights in any test group. No toxicologically significant 232S International Journal of Toxicology 31(Supplement 2)","page":64,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_014"} |
| CIR_vision_codex | NOAEL | >50 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"9; 19; 25","dose":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation.","effect":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation. In the 100 and 200 mg/kg groups, ataxia and a slight decrease in body weights were the evidence of maternal toxicity. No effects on reproductive parameters were noted. During the study, 9 con- trol animals and 31 test animals died. Based on maternal toxi- city, the NOAEL was >50 mg/kg per bw/d. Groups of 25 male and 25 female CD rats were used to evaluate the reproductive toxicity of C14-15AE7 in a 2- generation study. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No co...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_015"} |
| CIR_vision_codex | NOAEL | >0.5 | % | rat | oral | - | developmental toxicity | {"citation":"0; 05; 1","dose":"The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d).","effect":"dy. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No compound-related differences in fertility, gestation, or viability indices were observed, and the NOAEL for repro- duction with dietary administration of C14-15AE7 was >0.5% (equivalent to 250 mg/kg per bw/d). In addition, effects on the FC generation, that is offspring from the third mating of the F0 and F1 parenteral generation, were examined. Gravid female rats were necropsied and exam- ined on either day 13 or day 21 of gestation. Differences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weig...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_016"} |
| CIR_vision_codex | NOAEL | >250 | mg/ kg | rat | oral | - | developmental toxicity | {"citation":"250; 50; 10","dose":"Parental and offspring weight gain was reduced in the 250 mg/kg group.","effect":"w/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a statistically significant decrease in mean fetal liver weights was observed. None of these effects were considered test article related. The NOAEL for reproduction was >250 mg/ kg per bw/d, and the NOAELs for maternal and developmental toxicity were 50 mg/kg per bw/d C12AE6 in the diet. PEG methyl ethers. In a modified Chernoff-Kavlock test, groups of 10 gravid Alpk:AP Wistar rats were dosed daily by gavage with 250 or 1000 mg/kg PEG-3 methyl ether at a vol- ume of 10 mL/kg on days 7 to 16 of gestation.38 The negative control group of 10 gravid rats was given 10 mL/kg water and the 2 positive control groups were dosed with 50 and 250 mg/ kg methoxyethanol. The dams were allowed to deliver their pups. Treatmen...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_018"} |
| CIR_vision_codex | NOAEL | =1250 | mg/kg | rat | - | - | developmental toxicity | {"citation":"3; 625","dose":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group.","effect":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group. Fetal body weights were statistically significantly decreased in the 2500 and 5000 mg/ kg group and slightly decreased in the 1250 mg/kg group. The incidence of gross external, soft tissue, or skeletal fetal mal- formations was not affected at any dose level. Doses of \u00021250 mg/kg PEG-3 methyl ether did cause significant increases in reversible delayed ossification. The maternal and developmen- tal no-observable effect levels (NOELs) for rats were 625 mg/ Fiume et al 235S","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_019"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"rnal soft tissue, or skeletal malformations. Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_020"} |
| CIR_vision_codex | NOAEL | =1500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_021"} |
| CIR_vision_codex | NOAEL | =1650 | mg/kg bw | rat | - | - | developmental toxicity | {"citation":"20; 4; 1","dose":"In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals.","effect":"toxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals. Kidney weights of maternal rats were statistically significantly increased in the high-dose group compared to controls. A maternal NOAEL of 1650 mg/kg bw was assigned. The length of gestation was statistically significantly increased in animals of the high-dose group; however, the researchers found the biological significance of this questionable. Body weights of female pups of the mid- and high-dose groups and male pups of the high-dose group were significantly greater than controls at PND 0. At PND 68, male pups of the high-dose group weighed statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- an...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_022"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | - | - | - | NOAEL study | {"citation":"300; (3; 333","dose":"Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy.","effect":"d statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy. Behavioral evaluations did not find any dose-related effects on motor activity or active avoidance. A significant effect on auditory startle response parameters was noted; the significance of this finding was not clear to the researchers. The researchers assigned an NOEL of 300 mg/kg for offspring, while EPA assigned an NOAEL of 300 mg/kg for teratogenicity. Genotoxicity Laureths Laureth (chain length not specified) was tested in a number of genotoxicity studies. In an Ames study, laureth (3-333 mg/ plate) was negative with and without activation.70 In a standard transformation assay with BALB/c-3T3 cells, laureth (tested at 0.00132-0.0417 and 0.00625-0.0250 mmol/L) was inactive.71 Using Chinese hamster ovary (CHO) cells, laureth did not induce sister chromatid exchanges (concentrations of 3.08- 10.8 mg/mL with or 0.308-3.08 mg/mL w...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_023"} |
| CIR_vision_codex | NOAEL | =0 | ppm | rat | oral | - | developmental toxicity | {"citation":"64; 145; 33","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"g/kg (rabbits); inhalation LC50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reac...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_001"} |
| CIR_vision_codex | NOAEL | =5000 | ppm | rat | oral | - | developmental toxicity | {"citation":"50; 64; 145","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","effect":"50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reactions Important discussion it...","page":11,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_002"} |
| CIR_vision_codex | NOAEL | =0.375 | % | rat | oral | 21 days | repeated dose toxicity | {"citation":"21; 6; 0","dose":"The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11.","effect":"he diet for 21 days. A group of 6 male and 6 female rats were used as the control group. With all test compounds, growth was decreased in the 0.75% and 1.5% groups; changes in plasma protein con- centration and organ weights were associated with this effect. The liver appeared to be the major target organ, but it was stated that changes seemed to be indicative of an adaptive response rather than a true adverse effect. The lowest observa- ble effect level (LOEL) was 0.75% in the diet for all the test compounds. The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11. Groups of Colworth Wistar rats, number per group not spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_003"} |
| CIR_vision_codex | NOAEL | =7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | {"citation":"0; 03; 1","dose":"The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7.","effect":"spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed 0.25%, 0.5%, and 1.0% of the test materials. Upon microscopic examination, hepatocyte enlargement was noted in the livers. No effects were observed in reproductive organs. The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7. C14-15AE7 was fed to groups of 6 male and 6 female Wistar rats at concentrations of 300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relat...","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_004"} |
| CIR_vision_codex | NOAEL | =300 | ppm | rat | oral | 90 days | repeated dose toxicity | {"citation":"300; 10; 000","dose":"300 to 10 000 ppm of active ingredient for 90 days.","effect":"300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relative spleen to body weight was increased in males of the 10 000 ppm group. Microscopically, no compound-related effects were seen at any dose level. The dietary NOAEL was 300 ppm, corresponding to 15 mg/kg bw C14-15AE7. Fiume et al 223S","page":55,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_005"} |
| CIR_vision_codex | NOAEL | =1 | % | rat | oral | 90-day | repeated dose toxicity | {"citation":"90; 20; 0","dose":"The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females.","effect":"In another 90-day study, C14-15AE7 was also fed to groups of 20 male and 20 female albino rats at concentrations of 0.1%, 0.5%, and 1% in the diet. Five rats/gender were killed for necropsy on day 28. No treatment-related changes in body weights, feed intake, organ weights, clinical chemistry, or hematology were observed. The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females. In a 2-year study, rats, number per group not specified, were fed 0.1%, 0.5%, and 1% C12-13AE6.5 and C14-15AE7 in the diet. Reduced feed consumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- ca","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_006"} |
| CIR_vision_codex | NOAEL | =0.1 | % | rat | oral | 2 years | oral toxicity | {"citation":"0; 5; 1","dose":"The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d.","effect":"nsumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- carditis was greater in treated males than in controls. No other treatment-related lesions were observed. The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, correspondi...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_007"} |
| CIR_vision_codex | NOAEL | =190 | mg/kg | rat | oral | 2 years | oral toxicity | {"citation":"50; 0; 1","dose":"to 50 mg/kg per bw/d.","effect":"to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, corresponding to 190 and 162 mg/kg per bw/d for female and male rats, respectively. Deceths Groups of 5 female NZW rabbits were dosed orally by gavage with 2 mL/kg of 0.12, 0.25, 0.50, 0.75, or 1.0 g/kg deceth (avg chain length not specified) for 13 days.42 The negative control group was dosed with distilled water. The deaths that occurred were 1 rabbit dosed with 0.12 g/kg (day 8; thought to be gavage error); all 5 rabbits dosed with 0.25 g/kg (days 2-12); 4 rabbits dosed with 0.5 g/kg (days 2-14); 4 rabbits dosed with 0.75 g/kg (days 2-14); and all 5 ra...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_008"} |
| CIR_vision_codex | NOAEL | =1.6 | g/kg | rat | oral | 14 days | oral toxicity | {"citation":"0, 0; 75, 1; 6, 3","dose":"equently in the higher dose groups.","effect":"equently in the higher dose groups. Severe body weight loss was noted in the highest dose group, and slight to moderate body weight loss was observed in the other groups. Feed consumption was sig- nificantly decreased at some point for all groups. PEG Methyl Ethers Sprague-Dawley rats (number/gender/group not specified) were given 0, 0.75, 1.6, 3.9, and 8.0 g/kg per d PEG-3 methyl ether in the drinking water for 14 days.20 PEG-3 methyl ether was mildly to moderately toxic at 4 g/kg and severely toxic at \u00028 g/kg. A NOAEL of 1.6 g/kg per d was assigned. Groups of 15 male and15 female Sprague-Dawley CD rats were given drinking water containing target doses of 0, 400, 1200, and 4000 mg/kg per d PEG-3 methyl ether for 91 days.20 One female of the high-dose group died during the study. No treatment-related clinical signs of toxicity, alterations in func- tional observational battery, or gross microscopic lesions in the nervous system were found. Statistically significant increases in absolute liver weights were observed in males of the high- dose group; increased relative liver to body...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_009"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"10; 2; (0","dose":"Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females.","effect":"moderate or marked vacuolization. Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females. Treatment-related mild to moderate degeneration and/or minimal to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control gr...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_010"} |
| CIR_vision_codex | NOAEL | =1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | {"citation":"2; (0; 02","dose":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group.","effect":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control group of 24 males and 24 females was given untreated feed. All the animals were killed at the termination of dosing. Treatment-related clinical signs were not observed during the...","page":56,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_011"} |
| CIR_vision_codex | NOAEL | =4000 | mg/kg | rabbit | dermal | 12-day | NOAEL study | {"citation":"0; 3; 6","dose":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period.","effect":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period. No treatment-related adverse effects were observed. Slight scabbing or crusting was noted at the test site of a few mid- or high-dose males and females. Clinical chem- istry and hematological and urinalysis values that were statis- tically significantly different from control values were reported, but these effects were not considered by the research- ers to be treatment related. The NOAEL was determined to be 4000 mg/kg per d for this study. A group of 5 male and 5 female NZW rabbits was used to determine the dermal toxicity of PEG-3 methyl ether.20,38 A dose of 1000 mg/kg per d was applied neatly to the shaved skin (size of test area not specified) on the back of each animal, 6 h/ d, 5 d/week for 3 weeks, under an occlusive covering; the animals were restrained during dosing. Six hours after applica- tion, the site was rinsed. The negative control group of 10 animals was sham treated. The test sites were scored for dermal irritation immediately pri...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_012"} |
| CIR_vision_codex | NOAEL | <1200 | mg/kg bw | rat | dermal | 14-day | NOAEL study | {"citation":"12; 5; 1","dose":"Additional groups of 5 rats/gender per dose were used for interim evaluations.","effect":"niformly spread on a 12 cm2 area under a semiocclu- sive covering. Additional groups of 5 rats/gender per dose were used for interim evaluations. There were no indications of sys- temic toxicity, and the researchers did not consider testicular effects in 1 high-dose and 1 mid-dose male to be test article related. (Dermal effects were not described.) The researchers assigned a NOAEL of 4000 mg/kg per bw/d PEG-3 methyl ether. However, the EPA reviewed that data and, based on testicular effects in 2 males, assigned a NOAEL of >400 and<1200 mg/kg bw. The dermal toxicity of PEG-7 methyl ether was evaluated in 14-day and 28-day studies using CD(SD)BR rats.21 In the 14- day study, 10 males and 10 females were dosed dermally with 5000 mg/kg undiluted PEG-7 methyl ether. The test site was clipped of hair, and applications were made 5 days/week. The application site was not occluded, but a collar was placed on the animals just prior to dosing until study termination. Controls were handled similarly, except no applications were made. In the 28-day study, groups of 15 male rats were dosed der...","page":57,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_013"} |
| CIR_vision_codex | NOAEL | =25 | % | rat | - | - | reproductive toxicity | {"citation":"5; 10; 25","dose":"Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose.","effect":"mated. For both generations, the application sites were evaluated for irritation. The male rats of both generations were killed following mating. Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose. There was no mortality in the F0 generations, and deaths that did occur in the F1 generation were not attributed to treatment. No irritation was observed for any of the animals, but dry flaking skin was observed in the 10% and 25% dose groups. For effects on body weight, 10% was a no-effect level and 25% C9-11 pareth 6 caused a minimal decrease in body weights over the study. There were no compound-related effects on maternal body weights in any test group. No toxicologically significant 232S International Journal of Toxicology 31(Supplement 2)","page":64,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_014"} |
| CIR_vision_codex | NOAEL | >50 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"9; 19; 25","dose":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation.","effect":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation. In the 100 and 200 mg/kg groups, ataxia and a slight decrease in body weights were the evidence of maternal toxicity. No effects on reproductive parameters were noted. During the study, 9 con- trol animals and 31 test animals died. Based on maternal toxi- city, the NOAEL was >50 mg/kg per bw/d. Groups of 25 male and 25 female CD rats were used to evaluate the reproductive toxicity of C14-15AE7 in a 2- generation study. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No co...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_015"} |
| CIR_vision_codex | NOAEL | >0.5 | % | rat | oral | - | developmental toxicity | {"citation":"0; 05; 1","dose":"The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d).","effect":"dy. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No compound-related differences in fertility, gestation, or viability indices were observed, and the NOAEL for repro- duction with dietary administration of C14-15AE7 was >0.5% (equivalent to 250 mg/kg per bw/d). In addition, effects on the FC generation, that is offspring from the third mating of the F0 and F1 parenteral generation, were examined. Gravid female rats were necropsied and exam- ined on either day 13 or day 21 of gestation. Differences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weig...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_016"} |
| CIR_vision_codex | NOAEL | >250 | mg/ kg | rat | oral | - | developmental toxicity | {"citation":"250; 50; 10","dose":"Parental and offspring weight gain was reduced in the 250 mg/kg group.","effect":"w/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a statistically significant decrease in mean fetal liver weights was observed. None of these effects were considered test article related. The NOAEL for reproduction was >250 mg/ kg per bw/d, and the NOAELs for maternal and developmental toxicity were 50 mg/kg per bw/d C12AE6 in the diet. PEG methyl ethers. In a modified Chernoff-Kavlock test, groups of 10 gravid Alpk:AP Wistar rats were dosed daily by gavage with 250 or 1000 mg/kg PEG-3 methyl ether at a vol- ume of 10 mL/kg on days 7 to 16 of gestation.38 The negative control group of 10 gravid rats was given 10 mL/kg water and the 2 positive control groups were dosed with 50 and 250 mg/ kg methoxyethanol. The dams were allowed to deliver their pups. Treatmen...","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_018"} |
| CIR_vision_codex | NOAEL | =1250 | mg/kg | rat | - | - | developmental toxicity | {"citation":"3; 625","dose":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group.","effect":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group. Fetal body weights were statistically significantly decreased in the 2500 and 5000 mg/ kg group and slightly decreased in the 1250 mg/kg group. The incidence of gross external, soft tissue, or skeletal fetal mal- formations was not affected at any dose level. Doses of \u00021250 mg/kg PEG-3 methyl ether did cause significant increases in reversible delayed ossification. The maternal and developmen- tal no-observable effect levels (NOELs) for rats were 625 mg/ Fiume et al 235S","page":67,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_019"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"rnal soft tissue, or skeletal malformations. Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_020"} |
| CIR_vision_codex | NOAEL | =1500 | mg/kg | rat | oral | - | developmental toxicity | {"citation":"2; 250; 3","dose":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","effect":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_021"} |
| CIR_vision_codex | NOAEL | =1650 | mg/kg bw | rat | - | - | developmental toxicity | {"citation":"20; 4; 1","dose":"In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals.","effect":"toxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals. Kidney weights of maternal rats were statistically significantly increased in the high-dose group compared to controls. A maternal NOAEL of 1650 mg/kg bw was assigned. The length of gestation was statistically significantly increased in animals of the high-dose group; however, the researchers found the biological significance of this questionable. Body weights of female pups of the mid- and high-dose groups and male pups of the high-dose group were significantly greater than controls at PND 0. At PND 68, male pups of the high-dose group weighed statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- an...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_022"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | - | - | - | NOAEL study | {"citation":"300; (3; 333","dose":"Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy.","effect":"d statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy. Behavioral evaluations did not find any dose-related effects on motor activity or active avoidance. A significant effect on auditory startle response parameters was noted; the significance of this finding was not clear to the researchers. The researchers assigned an NOEL of 300 mg/kg for offspring, while EPA assigned an NOAEL of 300 mg/kg for teratogenicity. Genotoxicity Laureths Laureth (chain length not specified) was tested in a number of genotoxicity studies. In an Ames study, laureth (3-333 mg/ plate) was negative with and without activation.70 In a standard transformation assay with BALB/c-3T3 cells, laureth (tested at 0.00132-0.0417 and 0.00625-0.0250 mmol/L) was inactive.71 Using Chinese hamster ovary (CHO) cells, laureth did not induce sister chromatid exchanges (concentrations of 3.08- 10.8 mg/mL with or 0.308-3.08 mg/mL w...","page":68,"pdf":"PRS581.pdf","row_type":"noael_study","study_id":"PRS581_noael_023"} |
FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =4 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =1 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =2 | mg/kg bw/day | rabbit (Himalayan; male/female) | intravenous | GD 6-20 | developmental toxicity teratogenicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - DevelopmentalToxicityTeratogenicity - Examination of the influence on the pregnant rabbit and the fetus by intravenous administration_8926/94 - b747d769-caa5-4710-917c-b0a7168e8d76/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | <=3 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =4 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =1 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =2 | mg/kg bw/day | rabbit (Himalayan; male/female) | intravenous | GD 6-20 | developmental toxicity teratogenicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - DevelopmentalToxicityTeratogenicity - Examination of the influence on the pregnant rabbit and the fetus by intravenous administration_8926/94 - b747d769-caa5-4710-917c-b0a7168e8d76/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | <=3 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =4 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =1 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =2 | mg/kg bw/day | rabbit (Himalayan; male/female) | intravenous | GD 6-20 | developmental toxicity teratogenicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - DevelopmentalToxicityTeratogenicity - Examination of the influence on the pregnant rabbit and the fetus by intravenous administration_8926/94 - b747d769-caa5-4710-917c-b0a7168e8d76/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | <=3 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =4 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =1 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | =2 | mg/kg bw/day | rabbit (Himalayan; male/female) | intravenous | GD 6-20 | developmental toxicity teratogenicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - DevelopmentalToxicityTeratogenicity - Examination of the influence on the pregnant rabbit and the fetus by intravenous administration_8926/94 - b747d769-caa5-4710-917c-b0a7168e8d76/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOAEL | <=3 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=16 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=10 | mg/kg bw/day | rat (Crj: CD(SD); male/female) | intravenous | 9 weeks | reproductive toxicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - ToxicityReproduction - Fertility and early embryogenesis study in rats_3 - 635088d5-3b74-44ca-ac59-db9cf0055187/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: mortality: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=12 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=9 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 13 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Thirteen week intravenous toxicity study of ASK in rats_93208 - ecb3ee72-a144-4f20-b22b-4eea21e625e3/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: ophthalmological examination: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=14 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 7 days | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - 7-day subchronic toxicity study of polidocanol by intravenous administration to Sprague- Dawley rats (Comparison of polidocanol from three different manufacturers)_11128/1/98 - c3a8681f-f873-46bf-9779-a216475f993b/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: urinalysis: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=16 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=10 | mg/kg bw/day | rat (Crj: CD(SD); male/female) | intravenous | 9 weeks | reproductive toxicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - ToxicityReproduction - Fertility and early embryogenesis study in rats_3 - 635088d5-3b74-44ca-ac59-db9cf0055187/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: mortality: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=12 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=9 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 13 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Thirteen week intravenous toxicity study of ASK in rats_93208 - ecb3ee72-a144-4f20-b22b-4eea21e625e3/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: ophthalmological examination: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=14 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 7 days | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - 7-day subchronic toxicity study of polidocanol by intravenous administration to Sprague- Dawley rats (Comparison of polidocanol from three different manufacturers)_11128/1/98 - c3a8681f-f873-46bf-9779-a216475f993b/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: urinalysis: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=16 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=10 | mg/kg bw/day | rat (Crj: CD(SD); male/female) | intravenous | 9 weeks | reproductive toxicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - ToxicityReproduction - Fertility and early embryogenesis study in rats_3 - 635088d5-3b74-44ca-ac59-db9cf0055187/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: mortality: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=12 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=9 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 13 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Thirteen week intravenous toxicity study of ASK in rats_93208 - ecb3ee72-a144-4f20-b22b-4eea21e625e3/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: ophthalmological examination: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=14 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 7 days | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - 7-day subchronic toxicity study of polidocanol by intravenous administration to Sprague- Dawley rats (Comparison of polidocanol from three different manufacturers)_11128/1/98 - c3a8681f-f873-46bf-9779-a216475f993b/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: urinalysis: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=16 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=10 | mg/kg bw/day | rat (Crj: CD(SD); male/female) | intravenous | 9 weeks | reproductive toxicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - ToxicityReproduction - Fertility and early embryogenesis study in rats_3 - 635088d5-3b74-44ca-ac59-db9cf0055187/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: mortality: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=12 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=9 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 13 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Thirteen week intravenous toxicity study of ASK in rats_93208 - ecb3ee72-a144-4f20-b22b-4eea21e625e3/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: ophthalmological examination: no abnormal phenotype detected |
| FDA_Toxicity_652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z | NOEL | <=14 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 7 days | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - 7-day subchronic toxicity study of polidocanol by intravenous administration to Sprague- Dawley rats (Comparison of polidocanol from three different manufacturers)_11128/1/98 - c3a8681f-f873-46bf-9779-a216475f993b/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: urinalysis: no abnormal phenotype detected |
NTP_ICE_eye_irritation 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 0 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=778; Record_ID=eye_irritation_131; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=0; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP_ICE_eye_irritation | EPA Classification | 3 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=780; Record_ID=eye_irritation_131; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP_ICE_eye_irritation | Intensity | 0.01 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=782; Record_ID=eye_irritation_1240; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Vitrigel; Endpoint=Intensity; Response=0.01; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP_ICE_eye_irritation | Lag time | >180 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=781; Record_ID=eye_irritation_1240; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Vitrigel; Endpoint=Lag time; Response_Modifier=>; Response=180; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP_ICE_eye_irritation | Plateau level | 0 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=776; Record_ID=eye_irritation_1240; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Vitrigel; Endpoint=Plateau level; Response=0; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
ToxValDB_ECHA_IUCLID 13 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | >=1 | mg/kg bw/day | Dog | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca8781031; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=edema|enlarged axillary lymph nodes|enlarged lymph nodes|fibrosis|hemorrhage|hypertrophic|icterus|increased salivation|injection site inflammation|perivascular space|sclerosis; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852647_15852650_15852651_15852653:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_90460bd7595d59a8fd7f1d38a9e92d9a |
| ToxValDB_ECHA_IUCLID | LEL | >=3 | mg/kg bw/day | Dog | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca8781031; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=decreased hemoglobin concentration|vomiting; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852648_15852652:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0cac9b8fa82764b902364ceec9214f89 |
| ToxValDB_ECHA_IUCLID | LEL | =12 | mg/kg bw/day | Dog | injection | short-term; 4 weeks | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209de4b096bca878210e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=atrophy of prostate|decreased lymphocyte cell number|decreased prostate gland weight|increased urine protein level|urine bilirubin increased|urine occult blood|white blood cell count increased (lab result); TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853657_15853664:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7bd75246e08b9d7532c40fb8eb1cfb22 |
| ToxValDB_ECHA_IUCLID | LEL | >=6 | mg/kg bw/day | Dog | injection | short-term; 4 weeks | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209de4b096bca878210e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=increased salivation|injection site hemorrhage|injection site inflammation; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853656_15853658_15853659_15853660_15853662_15853663:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a770e72a4a71ac12639c36774abdce59 |
| ToxValDB_ECHA_IUCLID | LEL | =14 | mg/kg bw/day | Rat | injection | short-term; 7 days | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620c0e4b096bca87828b7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=abnormal skin appearance|decreased hematocrit|decreased hemoglobin concentration|decreased red blood cell count|fatty|fibrotic|granulomatous inflammation|hemorrhage|hepatocellular vacuolation|increased circulating alanine transaminase level|increased circulating alkaline phosphatase level|increased circulating aspartate transaminase level|increased circulating bilirubin level|increased liver weight|inflammation|tail swellings|white blood cell count increased (lab result); TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology|hematology|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853969_15853970:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6e9f91713b6921b078adb9f4149c8533 |
| ToxValDB_ECHA_IUCLID | LEL | =9 | mg/kg bw/day | Rat | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620e4e4b096bca878324d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=abnormal skin appearance|abnormal spleen morphology|decreased circulating phospholipid level|decreased circulating total protein level|extramedullary hematopoiesis|fibrosis|hyperplastic|increased mean corpuscular hemoglobin|increased mean corpuscular volume|reticulocytosis|tail necrosis|tail vein|thrombosis|white blood cell count increased (lab result); TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854528_15854529_15854530_15854532_15854536:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6c4eceb487df46aa8d3d53dd4ea1da1f |
| ToxValDB_ECHA_IUCLID | LOAEL | =700 | mg/kg bw/day | Rat | oral | subchronic (developmental); 71 days | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834756_15848645:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f812e38d830b1888e10fb9eda60dd506 |
| ToxValDB_ECHA_IUCLID | LOAEL | =300 | mg/kg bw/day | Rat | oral | subchronic; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=behavior: functional findings; TOXICOLOGICAL_EFFECT_CATEGORY=neurobehavior; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834757_15849016:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4e21ab53aa519098fca51503c8dd0696 |
| ToxValDB_ECHA_IUCLID | NOAEL | =300 | mg/kg bw/day | Rat | oral | subchronic (developmental); 71 days | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=behaviour (functional findings)|organ weights and organ / body weight ratios|body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|neurobehavior|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834756_15848645:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c92d6c62e8a8633e6c57c701d6886c3a |
| ToxValDB_ECHA_IUCLID | NOAEL | =100 | mg/kg bw/day | Rat | oral | subchronic; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=behaviour (functional findings)|organ weights and organ / body weight ratios|serum/plasma hormone analyses|body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|neurobehavior|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834757_15849016:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_23e2dcaa24521fcd6c8de8b2cc8292d4 |
| ToxValDB_ECHA_IUCLID | NOAEL | <=3 | mg/kg bw/day | Dog | injection | short-term; 4 weeks | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209de4b096bca878210e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853656_15853658_15853659_15853660_15853662_15853663:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4639760a6da81943f50da35ae755dc2c |
| ToxValDB_ECHA_IUCLID | NOAEL | =1 | mg/kg bw/day | Rat | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620e4e4b096bca878324d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854528_15854529_15854530_15854532_15854536:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_45dca679c50021fb3ad8ca35043d6192 |
| ToxValDB_ECHA_IUCLID | NOEL | <=9 | mg/kg bw/day | Dog | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca8781031; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=no abnormal phenotype detected; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852647_15852650_15852651_15852653:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ef370b4c6e8771a63d0cb6a9513e9912 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =4.93 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15634213:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cafcd2090903470c91ba676b489747c7 |
UnifiedCodex:CIR:beta.noael_studies 23 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | - | 4000 | mg/kg | rabbit | dermal | 12-day | - | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=4000; DOSE=ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period.; EFFECT=ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period. No treatment-related adverse effects were observed. Slight scabbing or crusting was noted at the test site of a few mid- or high-dose males and females. Clinical chem- istry and hematological and urinalysis values that were statis- tically significantly different from control values were reported, but these effects were not considered by the research- ers to be treatment related. The NOAEL was determined to be 4000 mg/kg per d for this study. A group of 5 male and 5 female NZW rabbits was used to determine the dermal toxicity of PEG-3 methyl ether.20,38 A dose of 1000 mg/kg per d was applied neatly to the shaved skin (size of test area not specified) on the back of each animal, 6 h/ d, 5 d/week for 3 weeks, under an occlusive covering; the animals were restrained during dosing. Six hours after applica- tion, the site was rinsed. The negative control group of 10 animals was sham treated. The test sites were scored for dermal irritation immediately pri...; CITATION=0; 3; 6; CITATION_NUMBERS=[3,6]; REFERENCE=0; 3; 6; DETAILS_JSON={"cas_number":"9002-92-0","citation":"0; 3; 6","dose":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period.","duration":"12-day","effect":"ed dermally with 0, 1000, 2500, or 4000 mg/kg per d PEG-3 methyl ether, 6 h/d.20 Nine applications were made during a 12-day period. No treatment-related adverse effects were observed. Slight scabbing or crusting was noted at the test site of a few mid- or high-dose males and females. Clinical chem- istry and hematological and urinalysis values that were statis- tically significantly different from control values were reported, but these effects were not considered by the research- ers to be treatment related. The NOAEL was determined to be 4000 mg/kg per d for this study. A group of 5 male and 5 female NZW rabbits was used to determine the dermal toxicity of PEG-3 methyl ether.20,38 A dose of 1000 mg/kg per d was applied neatly to the shaved skin (size of test area not specified) on the back of each animal, 6 h/ d, 5 d/week for 3 weeks, under an occlusive covering; the animals were restrained during dosing. Six hours after applica- tion, the site was rinsed. The negative control group of 10 animals was sham treated. The test sites were scored for dermal irritation immediately pri...","endpoint":"","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"4000","page":57,"route":"dermal","species":"rabbit","study_id":"PRS581_noael_012"} |
| UnifiedCodex:CIR:beta.noael_studies | - | <1200 | mg/kg bw | rat | dermal | 14-day | - | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=< 1200; DOSE=Additional groups of 5 rats/gender per dose were used for interim evaluations.; EFFECT=niformly spread on a 12 cm2 area under a semiocclu- sive covering. Additional groups of 5 rats/gender per dose were used for interim evaluations. There were no indications of sys- temic toxicity, and the researchers did not consider testicular effects in 1 high-dose and 1 mid-dose male to be test article related. (Dermal effects were not described.) The researchers assigned a NOAEL of 4000 mg/kg per bw/d PEG-3 methyl ether. However, the EPA reviewed that data and, based on testicular effects in 2 males, assigned a NOAEL of >400 and<1200 mg/kg bw. The dermal toxicity of PEG-7 methyl ether was evaluated in 14-day and 28-day studies using CD(SD)BR rats.21 In the 14- day study, 10 males and 10 females were dosed dermally with 5000 mg/kg undiluted PEG-7 methyl ether. The test site was clipped of hair, and applications were made 5 days/week. The application site was not occluded, but a collar was placed on the animals just prior to dosing until study termination. Controls were handled similarly, except no applications were made. In the 28-day study, groups of 15 male rats were dosed der...; CITATION=12; 5; 1; CITATION_NUMBERS=[12,5,1]; REFERENCE=12; 5; 1; DETAILS_JSON={"cas_number":"9002-92-0","citation":"12; 5; 1","dose":"Additional groups of 5 rats/gender per dose were used for interim evaluations.","duration":"14-day","effect":"niformly spread on a 12 cm2 area under a semiocclu- sive covering. Additional groups of 5 rats/gender per dose were used for interim evaluations. There were no indications of sys- temic toxicity, and the researchers did not consider testicular effects in 1 high-dose and 1 mid-dose male to be test article related. (Dermal effects were not described.) The researchers assigned a NOAEL of 4000 mg/kg per bw/d PEG-3 methyl ether. However, the EPA reviewed that data and, based on testicular effects in 2 males, assigned a NOAEL of >400 and<1200 mg/kg bw. The dermal toxicity of PEG-7 methyl ether was evaluated in 14-day and 28-day studies using CD(SD)BR rats.21 In the 14- day study, 10 males and 10 females were dosed dermally with 5000 mg/kg undiluted PEG-7 methyl ether. The test site was clipped of hair, and applications were made 5 days/week. The application site was not occluded, but a collar was placed on the animals just prior to dosing until study termination. Controls were handled similarly, except no applications were made. In the 28-day study, groups of 15 male rats were dosed der...","endpoint":"","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg bw","noael_value":"< 1200","page":57,"route":"dermal","species":"rat","study_id":"PRS581_noael_013"} |
| UnifiedCodex:CIR:beta.noael_studies | - | 300 | mg/kg | - | - | - | - | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=300; DOSE=Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy.; EFFECT=d statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy. Behavioral evaluations did not find any dose-related effects on motor activity or active avoidance. A significant effect on auditory startle response parameters was noted; the significance of this finding was not clear to the researchers. The researchers assigned an NOEL of 300 mg/kg for offspring, while EPA assigned an NOAEL of 300 mg/kg for teratogenicity. Genotoxicity Laureths Laureth (chain length not specified) was tested in a number of genotoxicity studies. In an Ames study, laureth (3-333 mg/ plate) was negative with and without activation.70 In a standard transformation assay with BALB/c-3T3 cells, laureth (tested at 0.00132-0.0417 and 0.00625-0.0250 mmol/L) was inactive.71 Using Chinese hamster ovary (CHO) cells, laureth did not induce sister chromatid exchanges (concentrations of 3.08- 10.8 mg/mL with or 0.308-3.08 mg/mL w...; CITATION=300; (3; 333; CITATION_NUMBERS=[300,3,333]; REFERENCE=300; (3; 333; DETAILS_JSON={"cas_number":"9002-92-0","citation":"300; (3; 333","dose":"Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy.","duration":"","effect":"d statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- and high-dose groups; no treatment-related effects for this observation were found at necropsy. Behavioral evaluations did not find any dose-related effects on motor activity or active avoidance. A significant effect on auditory startle response parameters was noted; the significance of this finding was not clear to the researchers. The researchers assigned an NOEL of 300 mg/kg for offspring, while EPA assigned an NOAEL of 300 mg/kg for teratogenicity. Genotoxicity Laureths Laureth (chain length not specified) was tested in a number of genotoxicity studies. In an Ames study, laureth (3-333 mg/ plate) was negative with and without activation.70 In a standard transformation assay with BALB/c-3T3 cells, laureth (tested at 0.00132-0.0417 and 0.00625-0.0250 mmol/L) was inactive.71 Using Chinese hamster ovary (CHO) cells, laureth did not induce sister chromatid exchanges (concentrations of 3.08- 10.8 mg/mL with or 0.308-3.08 mg/mL w...","endpoint":"","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":68,"route":"","species":"","study_id":"PRS581_noael_023"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 0 | ppm | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=000; DOSE=Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: 5.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:; EFFECT=g/kg (rabbits); inhalation LC50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, 6500 mg/m3 (cynomolgus monkey); 6 wks, 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: 5.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reac...; CITATION=64; 145; 33; CITATION_NUMBERS=[64,145,33]; REFERENCE=64; 145; 33; DETAILS_JSON={"cas_number":"9002-92-0","citation":"64; 145; 33","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","duration":"","effect":"g/kg (rabbits); inhalation LC50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reac...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"ppm","noael_value":"000","page":11,"route":"oral","species":"rat","study_id":"PRS581_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 5000 | ppm | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=5000; DOSE=Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: 5.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:; EFFECT=50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, 6500 mg/m3 (cynomolgus monkey); 6 wks, 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: 5.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reactions Important discussion it...; CITATION=50; 64; 145; CITATION_NUMBERS=[50,64,145]; REFERENCE=50; 64; 145; DETAILS_JSON={"cas_number":"9002-92-0","citation":"50; 64; 145","dose":"Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects:","duration":"","effect":"50: 64 to >145 g/kg (rats), 33.6 g/kg (cats), 61.1 g/kg (mice) Short-term inhalation:4 wks, \u00036500 mg/m3 (cynomolgus monkey); 6 wks, \u0003 10 g/kg no pulmonary changes (rats) Ocular toxicity to nonhuman primates after systemic exposure following administration by various routes is well documented Dermal irritation/sensitization No data Ocular irritation 100%: Necrosis of corneal epithelium in one study; moderate irritant in vivo and in vitro Repro/developmental toxicity Inhalation: maternal NOEL 10 000 ppm, teratogenic NOEL, 5000 ppm; oral admin: \u00035.2 mL/kg, no maternal toxicity (rats) Genotoxicity Mutagenic effects: RKþ mutatest; negative: Ames test, Syrian hamster embryo cell transformation assay, micronucleus test Carcinogenicity no data Clinical assessment of safety Toxicity in humans is due to the metabolism of the alcohol to formate and formic acid; can cause severe metabolic acidosis, blindness, and death, and all routes of exposure were toxicologically equivalent Closed patch test: 0.7%: no irritation; 5%: slight irritation; 7 and 70%, positive reactions Important discussion it...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":11,"route":"oral","species":"rat","study_id":"PRS581_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | >50 | mg/kg | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=> 50; DOSE=toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation.; EFFECT=toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation. In the 100 and 200 mg/kg groups, ataxia and a slight decrease in body weights were the evidence of maternal toxicity. No effects on reproductive parameters were noted. During the study, 9 con- trol animals and 31 test animals died. Based on maternal toxi- city, the NOAEL was >50 mg/kg per bw/d. Groups of 25 male and 25 female CD rats were used to evaluate the reproductive toxicity of C14-15AE7 in a 2- generation study. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No co...; CITATION=9; 19; 25; CITATION_NUMBERS=[9,19,25]; REFERENCE=9; 19; 25; DETAILS_JSON={"cas_number":"9002-92-0","citation":"9; 19; 25","dose":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation.","duration":"","effect":"toxicity of com- pounds analogous to laureth 9 was evaluated.19 Groups of 25 gravid female rabbits were dosed orally with 0, 50, 100, or 200 mg/kg bw C12AE6 on days 2 to 16 of gestation, and the animals were killed and necropsied on day 28 of gestation. In the 100 and 200 mg/kg groups, ataxia and a slight decrease in body weights were the evidence of maternal toxicity. No effects on reproductive parameters were noted. During the study, 9 con- trol animals and 31 test animals died. Based on maternal toxi- city, the NOAEL was >50 mg/kg per bw/d. Groups of 25 male and 25 female CD rats were used to evaluate the reproductive toxicity of C14-15AE7 in a 2- generation study. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No co...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"> 50","page":67,"route":"oral","species":"rat","study_id":"PRS581_noael_015"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | >0.5 | % | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=> 0.5; DOSE=The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d).; EFFECT=dy. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No compound-related differences in fertility, gestation, or viability indices were observed, and the NOAEL for repro- duction with dietary administration of C14-15AE7 was >0.5% (equivalent to 250 mg/kg per bw/d). In addition, effects on the FC generation, that is offspring from the third mating of the F0 and F1 parenteral generation, were examined. Gravid female rats were necropsied and exam- ined on either day 13 or day 21 of gestation. Differences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weig...; CITATION=0; 05; 1; CITATION_NUMBERS=[5,1]; REFERENCE=0; 05; 1; DETAILS_JSON={"cas_number":"9002-92-0","citation":"0; 05; 1","dose":"The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d).","duration":"","effect":"dy. The animals were fed a diet containing 0%, 0.05%, 0.1%, and 0.5% of the test article (equivalent to approx- imately 0, 25, 50, and 250 mg/kg per bw/d). In 3 test groups, males and females were given treated feed throughout the study; in another 3 groups, females only were dosed, and dos- ing was performed on days 6 to 15 of gestation. (Additional details regarding study and dosing regimen were not pro- vided.). No compound-related differences in fertility, gestation, or viability indices were observed, and the NOAEL for repro- duction with dietary administration of C14-15AE7 was >0.5% (equivalent to 250 mg/kg per bw/d). In addition, effects on the FC generation, that is offspring from the third mating of the F0 and F1 parenteral generation, were examined. Gravid female rats were necropsied and exam- ined on either day 13 or day 21 of gestation. Differences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weig...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"%","noael_value":"> 0.5","page":67,"route":"oral","species":"rat","study_id":"PRS581_noael_016"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 50 | mg/kg | rat | oral | 60 days | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=50; DOSE=Parental female rats and pups of the high-dose group had reduced body weight gains.; EFFECT=ences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weight gains. In the 0.5% continuous feeding test group, increased mean liver weights of males and females of the P1 generation and an increase in relative liver to body weights of males of the 0.5% continuous feeding group of the P2 generation at 60 days were considered compound-related. The NOAEL for maternal and developmen- tal toxicity was 50 mg/kg per bw/d. The reproductive toxicity of C12AE6 was evaluated in a similar study, and the 5 rats were fed 0, 25, 50, or 250 mg/kg per bw/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a stat...; CITATION=0; 5; 60; CITATION_NUMBERS=[5,60]; REFERENCE=0; 5; 60; DETAILS_JSON={"cas_number":"9002-92-0","citation":"0; 5; 60","dose":"Parental female rats and pups of the high-dose group had reduced body weight gains.","duration":"60 days","effect":"ences in maternal and fetal indices were observed in the test groups compared to the controls, but these effects were not considered test compound related. Parental female rats and pups of the high-dose group had reduced body weight gains. In the 0.5% continuous feeding test group, increased mean liver weights of males and females of the P1 generation and an increase in relative liver to body weights of males of the 0.5% continuous feeding group of the P2 generation at 60 days were considered compound-related. The NOAEL for maternal and developmen- tal toxicity was 50 mg/kg per bw/d. The reproductive toxicity of C12AE6 was evaluated in a similar study, and the 5 rats were fed 0, 25, 50, or 250 mg/kg per bw/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a stat...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":67,"route":"oral","species":"rat","study_id":"PRS581_noael_017"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | >250 | mg/ kg | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=> 250; DOSE=Parental and offspring weight gain was reduced in the 250 mg/kg group.; EFFECT=w/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a statistically significant decrease in mean fetal liver weights was observed. None of these effects were considered test article related. The NOAEL for reproduction was >250 mg/ kg per bw/d, and the NOAELs for maternal and developmental toxicity were 50 mg/kg per bw/d C12AE6 in the diet. PEG methyl ethers. In a modified Chernoff-Kavlock test, groups of 10 gravid Alpk:AP Wistar rats were dosed daily by gavage with 250 or 1000 mg/kg PEG-3 methyl ether at a vol- ume of 10 mL/kg on days 7 to 16 of gestation.38 The negative control group of 10 gravid rats was given 10 mL/kg water and the 2 positive control groups were dosed with 50 and 250 mg/ kg methoxyethanol. The dams were allowed to deliver their pups. Treatmen...; CITATION=250; 50; 10; CITATION_NUMBERS=[250,50,10]; REFERENCE=250; 50; 10; DETAILS_JSON={"cas_number":"9002-92-0","citation":"250; 50; 10","dose":"Parental and offspring weight gain was reduced in the 250 mg/kg group.","duration":"","effect":"w/d of the test article in the diet. No treatment-related effects on behavior, appearance, survival, or fertility were observed in any of the test groups. Parental and offspring weight gain was reduced in the 250 mg/kg group. In the 250 mg/kg group, statistically significant increases in embryo leth- ality and soft tissue anomalies were observed, and in the 50 mg/ kg group, a statistically significant decrease in mean fetal liver weights was observed. None of these effects were considered test article related. The NOAEL for reproduction was >250 mg/ kg per bw/d, and the NOAELs for maternal and developmental toxicity were 50 mg/kg per bw/d C12AE6 in the diet. PEG methyl ethers. In a modified Chernoff-Kavlock test, groups of 10 gravid Alpk:AP Wistar rats were dosed daily by gavage with 250 or 1000 mg/kg PEG-3 methyl ether at a vol- ume of 10 mL/kg on days 7 to 16 of gestation.38 The negative control group of 10 gravid rats was given 10 mL/kg water and the 2 positive control groups were dosed with 50 and 250 mg/ kg methoxyethanol. The dams were allowed to deliver their pups. Treatmen...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/ kg","noael_value":"> 250","page":67,"route":"oral","species":"rat","study_id":"PRS581_noael_018"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1250 | mg/kg | rat | - | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=1250; DOSE=gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group.; EFFECT=gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group. Fetal body weights were statistically significantly decreased in the 2500 and 5000 mg/ kg group and slightly decreased in the 1250 mg/kg group. The incidence of gross external, soft tissue, or skeletal fetal mal- formations was not affected at any dose level. Doses of 1250 mg/kg PEG-3 methyl ether did cause significant increases in reversible delayed ossification. The maternal and developmen- tal no-observable effect levels (NOELs) for rats were 625 mg/ Fiume et al 235S; CITATION=3; 625; CITATION_NUMBERS=[3,625]; REFERENCE=3; 625; DETAILS_JSON={"cas_number":"9002-92-0","citation":"3; 625","dose":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group.","duration":"","effect":"gnancy rates were not affected, but embryo lethality was statistically significantly increased in the high-dose group. Fetal body weights were statistically significantly decreased in the 2500 and 5000 mg/ kg group and slightly decreased in the 1250 mg/kg group. The incidence of gross external, soft tissue, or skeletal fetal mal- formations was not affected at any dose level. Doses of \u00021250 mg/kg PEG-3 methyl ether did cause significant increases in reversible delayed ossification. The maternal and developmen- tal no-observable effect levels (NOELs) for rats were 625 mg/ Fiume et al 235S","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"1250","page":67,"route":"","species":"rat","study_id":"PRS581_noael_019"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 500 | mg/kg | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=500; DOSE=Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.; EFFECT=rnal soft tissue, or skeletal malformations. Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs...; CITATION=2; 250; 3; CITATION_NUMBERS=[2,250,3]; REFERENCE=2; 250; 3; DETAILS_JSON={"cas_number":"9002-92-0","citation":"2; 250; 3","dose":"Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","duration":"","effect":"rnal soft tissue, or skeletal malformations. Decreased live litter sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"500","page":68,"route":"oral","species":"rat","study_id":"PRS581_noael_020"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1500 | mg/kg | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=1500; DOSE=sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.; EFFECT=sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant...; CITATION=2; 250; 3; CITATION_NUMBERS=[2,250,3]; REFERENCE=2; 250; 3; DETAILS_JSON={"cas_number":"9002-92-0","citation":"2; 250; 3","dose":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant.","duration":"","effect":"sizes and increased resorption rates in the 1000 and 1500 mg/kg groups occurred but were not statistically significant. Fetal and/or litter incidence of 2 common skeletal variations, angulated hyoid alae and reversible delayed ossification of the xiphoid, were statistically significantly increased in the 1500 mg/kg group. For rabbits, the maternal and developmental toxicity NOELs were 250 and 1000 mg/kg per d PEG-3 methyl ether, respec- tively. The NOAEL for maternal toxicity was 500 mg/kg per d, and the presumed NOAEL for developmental toxicity was 1500 mg/kg per d. Groups of 64 gravid female Sprague-Dawley rats were dosed orally, by gavage, with 0, 300, 1650, or 3000 mg/kg per d PEG-3 methyl ether on days 6 to 21 of gestation in a study of developmental neurotoxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"1500","page":68,"route":"oral","species":"rat","study_id":"PRS581_noael_021"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1650 | mg/kg bw | rat | - | - | developmental toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=1650; DOSE=In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals.; EFFECT=toxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals. Kidney weights of maternal rats were statistically significantly increased in the high-dose group compared to controls. A maternal NOAEL of 1650 mg/kg bw was assigned. The length of gestation was statistically significantly increased in animals of the high-dose group; however, the researchers found the biological significance of this questionable. Body weights of female pups of the mid- and high-dose groups and male pups of the high-dose group were significantly greater than controls at PND 0. At PND 68, male pups of the high-dose group weighed statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- an...; CITATION=20; 4; 1; CITATION_NUMBERS=[20,4,1]; REFERENCE=20; 4; 1; DETAILS_JSON={"cas_number":"9002-92-0","citation":"20; 4; 1","dose":"In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals.","duration":"","effect":"toxicity.20 The pups were delivered, litters were culled on day 4, and the offspring were observed in a number of tests. One male and 1 female pup from each litter were killed on PNDs 22 and 68. In maternal animals, no dose- related patterns of clinical signs of toxicity or mortality were noted, and there were no significant differences in body weights between test and control animals. Kidney weights of maternal rats were statistically significantly increased in the high-dose group compared to controls. A maternal NOAEL of 1650 mg/kg bw was assigned. The length of gestation was statistically significantly increased in animals of the high-dose group; however, the researchers found the biological significance of this questionable. Body weights of female pups of the mid- and high-dose groups and male pups of the high-dose group were significantly greater than controls at PND 0. At PND 68, male pups of the high-dose group weighed statistically significantly less than controls. Male pup development, determined by time of testes descent, was significantly advanced in pups of the mid- an...","endpoint":"developmental toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1650","page":68,"route":"","species":"rat","study_id":"PRS581_noael_022"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 0.1 | % | rat | oral | 2 years | oral toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=0.1; DOSE=The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d.; EFFECT=nsumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- carditis was greater in treated males than in controls. No other treatment-related lesions were observed. The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, correspondi...; CITATION=0; 5; 1; CITATION_NUMBERS=[5,1]; REFERENCE=0; 5; 1; DETAILS_JSON={"cas_number":"9002-92-0","citation":"0; 5; 1","dose":"The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d.","duration":"2 years","effect":"nsumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- carditis was greater in treated males than in controls. No other treatment-related lesions were observed. The NOAEL was 0.1%, corresponding to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, correspondi...","endpoint":"oral toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"%","noael_value":"0.1","page":56,"route":"oral","species":"rat","study_id":"PRS581_noael_007"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 190 | mg/kg | rat | oral | 2 years | oral toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=190; 162; DOSE=to 50 mg/kg per bw/d.; EFFECT=to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, corresponding to 190 and 162 mg/kg per bw/d for female and male rats, respectively. Deceths Groups of 5 female NZW rabbits were dosed orally by gavage with 2 mL/kg of 0.12, 0.25, 0.50, 0.75, or 1.0 g/kg deceth (avg chain length not specified) for 13 days.42 The negative control group was dosed with distilled water. The deaths that occurred were 1 rabbit dosed with 0.12 g/kg (day 8; thought to be gavage error); all 5 rabbits dosed with 0.25 g/kg (days 2-12); 4 rabbits dosed with 0.5 g/kg (days 2-14); 4 rabbits dosed with 0.75 g/kg (days 2-14); and all 5 ra...; CITATION=50; 0; 1; CITATION_NUMBERS=[50,1]; REFERENCE=50; 0; 1; DETAILS_JSON={"cas_number":"9002-92-0","citation":"50; 0; 1","dose":"to 50 mg/kg per bw/d.","duration":"2 years","effect":"to 50 mg/kg per bw/d. C14-15AE7 was fed to rats, number per group not specified, at concentrations of 0%, 0.1%, 0.5%, and 1% in the diet for 2 years. Body weights were decreased for females of the 0.5% and 1% groups and for males of the 1% group. Increases in relative liver, kidney, heart, and thyroid/parathyroid gland to body weights were observed in the high-dose group. The only significant microscopic finding was focal myocarditis in all test groups; this lesion was observed at 13 months but not at 2 years. The NOAEL was 0.5%, corresponding to 190 and 162 mg/kg per bw/d for female and male rats, respectively. Deceths Groups of 5 female NZW rabbits were dosed orally by gavage with 2 mL/kg of 0.12, 0.25, 0.50, 0.75, or 1.0 g/kg deceth (avg chain length not specified) for 13 days.42 The negative control group was dosed with distilled water. The deaths that occurred were 1 rabbit dosed with 0.12 g/kg (day 8; thought to be gavage error); all 5 rabbits dosed with 0.25 g/kg (days 2-12); 4 rabbits dosed with 0.5 g/kg (days 2-14); 4 rabbits dosed with 0.75 g/kg (days 2-14); and all 5 ra...","endpoint":"oral toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"190; 162","page":56,"route":"oral","species":"rat","study_id":"PRS581_noael_008"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 1.6 | g/kg | rat | oral | 14 days | oral toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=1.6; DOSE=equently in the higher dose groups.; EFFECT=equently in the higher dose groups. Severe body weight loss was noted in the highest dose group, and slight to moderate body weight loss was observed in the other groups. Feed consumption was sig- nificantly decreased at some point for all groups. PEG Methyl Ethers Sprague-Dawley rats (number/gender/group not specified) were given 0, 0.75, 1.6, 3.9, and 8.0 g/kg per d PEG-3 methyl ether in the drinking water for 14 days.20 PEG-3 methyl ether was mildly to moderately toxic at 4 g/kg and severely toxic at 8 g/kg. A NOAEL of 1.6 g/kg per d was assigned. Groups of 15 male and15 female Sprague-Dawley CD rats were given drinking water containing target doses of 0, 400, 1200, and 4000 mg/kg per d PEG-3 methyl ether for 91 days.20 One female of the high-dose group died during the study. No treatment-related clinical signs of toxicity, alterations in func- tional observational battery, or gross microscopic lesions in the nervous system were found. Statistically significant increases in absolute liver weights were observed in males of the high- dose group; increased relative liver to body...; CITATION=0, 0; 75, 1; 6, 3; CITATION_NUMBERS=[75,1,6,3]; REFERENCE=0, 0; 75, 1; 6, 3; DETAILS_JSON={"cas_number":"9002-92-0","citation":"0, 0; 75, 1; 6, 3","dose":"equently in the higher dose groups.","duration":"14 days","effect":"equently in the higher dose groups. Severe body weight loss was noted in the highest dose group, and slight to moderate body weight loss was observed in the other groups. Feed consumption was sig- nificantly decreased at some point for all groups. PEG Methyl Ethers Sprague-Dawley rats (number/gender/group not specified) were given 0, 0.75, 1.6, 3.9, and 8.0 g/kg per d PEG-3 methyl ether in the drinking water for 14 days.20 PEG-3 methyl ether was mildly to moderately toxic at 4 g/kg and severely toxic at \u00028 g/kg. A NOAEL of 1.6 g/kg per d was assigned. Groups of 15 male and15 female Sprague-Dawley CD rats were given drinking water containing target doses of 0, 400, 1200, and 4000 mg/kg per d PEG-3 methyl ether for 91 days.20 One female of the high-dose group died during the study. No treatment-related clinical signs of toxicity, alterations in func- tional observational battery, or gross microscopic lesions in the nervous system were found. Statistically significant increases in absolute liver weights were observed in males of the high- dose group; increased relative liver to body...","endpoint":"oral toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"g/kg","noael_value":"1.6","page":56,"route":"oral","species":"rat","study_id":"PRS581_noael_009"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 400 | mg/kg | rat | oral | 13 weeks | oral toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=400; DOSE=Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females.; LOAEL_VALUE=1200 mg/ kg; EFFECT=moderate or marked vacuolization. Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females. Treatment-related mild to moderate degeneration and/or minimal to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control gr...; CITATION=10; 2; (0; CITATION_NUMBERS=[10,2]; REFERENCE=10; 2; (0; DETAILS_JSON={"cas_number":"9002-92-0","citation":"10; 2; (0","dose":"Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females.","duration":"13 weeks","effect":"moderate or marked vacuolization. Minimal or mild hepatocellular hyper- trophy was seen in 10 high-dose females. Treatment-related mild to moderate degeneration and/or minimal to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control gr...","endpoint":"oral toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"1200 mg/ kg","noael_unit":"mg/kg","noael_value":"400","page":56,"route":"oral","species":"rat","study_id":"PRS581_noael_010"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=1200; DOSE=to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group.; LOAEL_VALUE=1200 mg/ kg; EFFECT=to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control group of 24 males and 24 females was given untreated feed. All the animals were killed at the termination of dosing. Treatment-related clinical signs were not observed during the...; CITATION=2; (0; 02; CITATION_NUMBERS=[2]; REFERENCE=2; (0; 02; DETAILS_JSON={"cas_number":"9002-92-0","citation":"2; (0; 02","dose":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group.","duration":"13 weeks","effect":"to moderate atrophy of the seminiferous tubules was observed in males of the high-dose group. The researcher stated that a possible con- tributing factor in the development of testicular lesions was low-level contamination with 2-methoxyethanol (0.02%- 0.04%), which is a testicular toxicant. Based on liver effects, the researchers assigned a NOAEL of 400 mg/kg per d and a lowest observable adverse effect level (LOAEL) of 1200 mg/ kg per d PEG-3 methyl ether. Based on testicular effects, the researchers assigned a NOAEL of 1200 mg/kg per d and LOAEL of 4000 mg/kg per d. However, the Environmental Protection Agency (EPA) reviewed the information and deter- mined that the LOAEL for testicular effects in this study was between 400 and 1200 mg/kg per day. C14-15 pareths. Groups of 12 male and 12 female Wistar rats were fed diet containing 300, 1000, 3000, or 10 000 ppm C14-15 pareth 7 for 13 weeks.49 A control group of 24 males and 24 females was given untreated feed. All the animals were killed at the termination of dosing. Treatment-related clinical signs were not observed during the...","endpoint":"oral toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"1200 mg/ kg","noael_unit":"mg/kg","noael_value":"1200","page":56,"route":"oral","species":"rat","study_id":"PRS581_noael_011"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 0.375 | % | rat | oral | 21 days | repeated dose toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=0.375; DOSE=The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11.; EFFECT=he diet for 21 days. A group of 6 male and 6 female rats were used as the control group. With all test compounds, growth was decreased in the 0.75% and 1.5% groups; changes in plasma protein con- centration and organ weights were associated with this effect. The liver appeared to be the major target organ, but it was stated that changes seemed to be indicative of an adaptive response rather than a true adverse effect. The lowest observa- ble effect level (LOEL) was 0.75% in the diet for all the test compounds. The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11. Groups of Colworth Wistar rats, number per group not spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed...; CITATION=21; 6; 0; CITATION_NUMBERS=[21,6]; REFERENCE=21; 6; 0; DETAILS_JSON={"cas_number":"9002-92-0","citation":"21; 6; 0","dose":"The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11.","duration":"21 days","effect":"he diet for 21 days. A group of 6 male and 6 female rats were used as the control group. With all test compounds, growth was decreased in the 0.75% and 1.5% groups; changes in plasma protein con- centration and organ weights were associated with this effect. The liver appeared to be the major target organ, but it was stated that changes seemed to be indicative of an adaptive response rather than a true adverse effect. The lowest observa- ble effect level (LOEL) was 0.75% in the diet for all the test compounds. The no-observable adverse effect level (NOAEL) was 0.375% in the diet for these compounds, corresponding to 502 mg/kg bw C12-14AE7, 459 mg/kg bw C12-15AE7, and 519 mg/kg bw C12-15AE11. Groups of Colworth Wistar rats, number per group not spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed...","endpoint":"repeated dose toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"%","noael_value":"0.375","page":55,"route":"oral","species":"rat","study_id":"PRS581_noael_003"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=7; 110; DOSE=The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7.; EFFECT=spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed 0.25%, 0.5%, and 1.0% of the test materials. Upon microscopic examination, hepatocyte enlargement was noted in the livers. No effects were observed in reproductive organs. The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7. C14-15AE7 was fed to groups of 6 male and 6 female Wistar rats at concentrations of 300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relat...; CITATION=0; 03; 1; CITATION_NUMBERS=[3,1]; REFERENCE=0; 03; 1; DETAILS_JSON={"cas_number":"9002-92-0","citation":"0; 03; 1","dose":"The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7.","duration":"90 days","effect":"spec- ified, were fed 0.03% to 1.0% active material C12-15AE7 and C12-14AE7 in the diet for 90 days. (Active was not defined.) With both compounds, body weight gains were significantly decreased in male and female rats fed doses >0.25%. Relative liver to body weights were significantly increased in males fed 0.5% and 1.0% and in females fed 0.25%, 0.5%, and 1.0% of the test materials. Upon microscopic examination, hepatocyte enlargement was noted in the livers. No effects were observed in reproductive organs. The NOAEL for these compounds was 0.125% in the diet, which corresponded to 102 mg/kg per bw/d C12-15AE7 and 110 mg/kg per bw/d C12-14AE7. C14-15AE7 was fed to groups of 6 male and 6 female Wistar rats at concentrations of 300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relat...","endpoint":"repeated dose toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"mg/kg","noael_value":"7; 110","page":55,"route":"oral","species":"rat","study_id":"PRS581_noael_004"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 300 | ppm | rat | oral | 90 days | repeated dose toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=300; DOSE=300 to 10 000 ppm of active ingredient for 90 days.; EFFECT=300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relative spleen to body weight was increased in males of the 10 000 ppm group. Microscopically, no compound-related effects were seen at any dose level. The dietary NOAEL was 300 ppm, corresponding to 15 mg/kg bw C14-15AE7. Fiume et al 223S; CITATION=300; 10; 000; CITATION_NUMBERS=[300,10]; REFERENCE=300; 10; 000; DETAILS_JSON={"cas_number":"9002-92-0","citation":"300; 10; 000","dose":"300 to 10 000 ppm of active ingredient for 90 days.","duration":"90 days","effect":"300 to 10 000 ppm of active ingredient for 90 days. The control group was comprised of 12 male and 12 female rats. Body weights were decreased in males of the 10 000 ppm group and females of the 3000 ppm group. Relative liver to body weights were increased in males and females of the 3000 and 10 000 ppm groups and in females of the 1000 ppm group; the relative spleen to body weight was increased in males of the 10 000 ppm group. Microscopically, no compound-related effects were seen at any dose level. The dietary NOAEL was 300 ppm, corresponding to 15 mg/kg bw C14-15AE7. Fiume et al 223S","endpoint":"repeated dose toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"ppm","noael_value":"300","page":55,"route":"oral","species":"rat","study_id":"PRS581_noael_005"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 1 | % | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=1; DOSE=The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females.; EFFECT=In another 90-day study, C14-15AE7 was also fed to groups of 20 male and 20 female albino rats at concentrations of 0.1%, 0.5%, and 1% in the diet. Five rats/gender were killed for necropsy on day 28. No treatment-related changes in body weights, feed intake, organ weights, clinical chemistry, or hematology were observed. The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females. In a 2-year study, rats, number per group not specified, were fed 0.1%, 0.5%, and 1% C12-13AE6.5 and C14-15AE7 in the diet. Reduced feed consumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- ca; CITATION=90; 20; 0; CITATION_NUMBERS=[90,20]; REFERENCE=90; 20; 0; DETAILS_JSON={"cas_number":"9002-92-0","citation":"90; 20; 0","dose":"The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females.","duration":"90-day","effect":"In another 90-day study, C14-15AE7 was also fed to groups of 20 male and 20 female albino rats at concentrations of 0.1%, 0.5%, and 1% in the diet. Five rats/gender were killed for necropsy on day 28. No treatment-related changes in body weights, feed intake, organ weights, clinical chemistry, or hematology were observed. The NOAEL was 1% C14-15AE7, corresponding to 700 mg/kg bw for males and 785 mg/kg bw for females. In a 2-year study, rats, number per group not specified, were fed 0.1%, 0.5%, and 1% C12-13AE6.5 and C14-15AE7 in the diet. Reduced feed consumption, resulting in decreased body weight gains, was observed in the females fed 0.5% and 1% and in the males fed 1%. Relative liver, kidney, and brain to body weights were increased in the 0.5% and 1% female groups, an increased relative heart to body weight was observed in the 1% female group, and increased relative liver to body weights were observed in the 1% male group. The incidence of focal myo- ca","endpoint":"repeated dose toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"%","noael_value":"1","page":56,"route":"oral","species":"rat","study_id":"PRS581_noael_006"} |
| UnifiedCodex:CIR:beta.noael_studies | reproductive toxicity | 25 | % | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=PRS581; REPORT_TITLE=Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel Liebler3, James G. Marks, Jr3, Ronald C. Shank3, Thomas J. Sla; OPINION_NUMBER=PRS581; COMMITTEE=CIR Expert Panel; REPORT_DATE=In 1983; VALUE_TEXT=25; DOSE=Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose.; EFFECT=mated. For both generations, the application sites were evaluated for irritation. The male rats of both generations were killed following mating. Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose. There was no mortality in the F0 generations, and deaths that did occur in the F1 generation were not attributed to treatment. No irritation was observed for any of the animals, but dry flaking skin was observed in the 10% and 25% dose groups. For effects on body weight, 10% was a no-effect level and 25% C9-11 pareth 6 caused a minimal decrease in body weights over the study. There were no compound-related effects on maternal body weights in any test group. No toxicologically significant 232S International Journal of Toxicology 31(Supplement 2); CITATION=5; 10; 25; CITATION_NUMBERS=[5,10,25]; REFERENCE=5; 10; 25; DETAILS_JSON={"cas_number":"9002-92-0","citation":"5; 10; 25","dose":"Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose.","duration":"","effect":"mated. For both generations, the application sites were evaluated for irritation. The male rats of both generations were killed following mating. Gross necrop- sies were performed on all F0 and F1 parents and on 5 pups/ gender per dose. There was no mortality in the F0 generations, and deaths that did occur in the F1 generation were not attributed to treatment. No irritation was observed for any of the animals, but dry flaking skin was observed in the 10% and 25% dose groups. For effects on body weight, 10% was a no-effect level and 25% C9-11 pareth 6 caused a minimal decrease in body weights over the study. There were no compound-related effects on maternal body weights in any test group. No toxicologically significant 232S International Journal of Toxicology 31(Supplement 2)","endpoint":"reproductive toxicity","ingredient":"Alkyl PEG Ethers","loael_value":"","noael_unit":"%","noael_value":"25","page":64,"route":"","species":"rat","study_id":"PRS581_noael_014"} |
openFDA substances 60 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | Z95S6G8201 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"Z95S6G8201"} |
| openFDA substances | FDA UNII substance identifier | ELB3Y6474W | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"ELB3Y6474W"} |
| openFDA substances | FDA UNII substance identifier | 6SU0SC83AH | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6SU0SC83AH"} |
| openFDA substances | FDA UNII substance identifier | RPD53041LR | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"RPD53041LR"} |
| openFDA substances | FDA UNII substance identifier | W9D845551A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"W9D845551A"} |
| openFDA substances | FDA UNII substance identifier | BD7AST04GA | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"BD7AST04GA"} |
| openFDA substances | FDA UNII substance identifier | N72LMW566G | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"N72LMW566G"} |
| openFDA substances | FDA UNII substance identifier | MGU0HEW21Q | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"MGU0HEW21Q"} |
| openFDA substances | FDA UNII substance identifier | KZF7XN8153 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"KZF7XN8153"} |
| openFDA substances | FDA UNII substance identifier | 0AWH8BFG9A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"0AWH8BFG9A"} |
| openFDA substances | FDA UNII substance identifier | APG12V4K45 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"APG12V4K45"} |
| openFDA substances | FDA UNII substance identifier | QU7U88D04I | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"QU7U88D04I"} |
| openFDA substances | FDA UNII substance identifier | WG3R46N0SV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"WG3R46N0SV"} |
| openFDA substances | FDA UNII substance identifier | 6HQ855798J | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6HQ855798J"} |
| openFDA substances | FDA UNII substance identifier | 002FR4N8OV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"002FR4N8OV"} |
| openFDA substances | FDA UNII substance identifier | Z95S6G8201 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"Z95S6G8201"} |
| openFDA substances | FDA UNII substance identifier | Z95S6G8201 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"Z95S6G8201"} |
| openFDA substances | FDA UNII substance identifier | ELB3Y6474W | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"ELB3Y6474W"} |
| openFDA substances | FDA UNII substance identifier | ELB3Y6474W | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"ELB3Y6474W"} |
| openFDA substances | FDA UNII substance identifier | 6SU0SC83AH | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6SU0SC83AH"} |
| openFDA substances | FDA UNII substance identifier | 6SU0SC83AH | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6SU0SC83AH"} |
| openFDA substances | FDA UNII substance identifier | RPD53041LR | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"RPD53041LR"} |
| openFDA substances | FDA UNII substance identifier | RPD53041LR | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"RPD53041LR"} |
| openFDA substances | FDA UNII substance identifier | W9D845551A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"W9D845551A"} |
| openFDA substances | FDA UNII substance identifier | W9D845551A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"W9D845551A"} |
| openFDA substances | FDA UNII substance identifier | BD7AST04GA | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"BD7AST04GA"} |
| openFDA substances | FDA UNII substance identifier | BD7AST04GA | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"BD7AST04GA"} |
| openFDA substances | FDA UNII substance identifier | N72LMW566G | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"N72LMW566G"} |
| openFDA substances | FDA UNII substance identifier | N72LMW566G | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"N72LMW566G"} |
| openFDA substances | FDA UNII substance identifier | Z95S6G8201 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"Z95S6G8201"} |
| openFDA substances | FDA UNII substance identifier | MGU0HEW21Q | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"MGU0HEW21Q"} |
| openFDA substances | FDA UNII substance identifier | MGU0HEW21Q | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"MGU0HEW21Q"} |
| openFDA substances | FDA UNII substance identifier | ELB3Y6474W | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"ELB3Y6474W"} |
| openFDA substances | FDA UNII substance identifier | 6SU0SC83AH | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6SU0SC83AH"} |
| openFDA substances | FDA UNII substance identifier | RPD53041LR | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"RPD53041LR"} |
| openFDA substances | FDA UNII substance identifier | W9D845551A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"W9D845551A"} |
| openFDA substances | FDA UNII substance identifier | BD7AST04GA | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"BD7AST04GA"} |
| openFDA substances | FDA UNII substance identifier | OAH19558U1 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"OAH19558U1"} |
| openFDA substances | FDA UNII substance identifier | N72LMW566G | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"N72LMW566G"} |
| openFDA substances | FDA UNII substance identifier | KZF7XN8153 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"KZF7XN8153"} |
| openFDA substances | FDA UNII substance identifier | KZF7XN8153 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"KZF7XN8153"} |
| openFDA substances | FDA UNII substance identifier | MGU0HEW21Q | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"MGU0HEW21Q"} |
| openFDA substances | FDA UNII substance identifier | 0AWH8BFG9A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"0AWH8BFG9A"} |
| openFDA substances | FDA UNII substance identifier | 0AWH8BFG9A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"0AWH8BFG9A"} |
| openFDA substances | FDA UNII substance identifier | APG12V4K45 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"APG12V4K45"} |
| openFDA substances | FDA UNII substance identifier | APG12V4K45 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"APG12V4K45"} |
| openFDA substances | FDA UNII substance identifier | QU7U88D04I | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"QU7U88D04I"} |
| openFDA substances | FDA UNII substance identifier | WG3R46N0SV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"WG3R46N0SV"} |
| openFDA substances | FDA UNII substance identifier | WG3R46N0SV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"WG3R46N0SV"} |
| openFDA substances | FDA UNII substance identifier | KZF7XN8153 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"KZF7XN8153"} |
| openFDA substances | FDA UNII substance identifier | 6HQ855798J | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6HQ855798J"} |
| openFDA substances | FDA UNII substance identifier | 6HQ855798J | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6HQ855798J"} |
| openFDA substances | FDA UNII substance identifier | 002FR4N8OV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"002FR4N8OV"} |
| openFDA substances | FDA UNII substance identifier | 002FR4N8OV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"002FR4N8OV"} |
| openFDA substances | FDA UNII substance identifier | 0AWH8BFG9A | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"0AWH8BFG9A"} |
| openFDA substances | FDA UNII substance identifier | APG12V4K45 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"APG12V4K45"} |
| openFDA substances | FDA UNII substance identifier | QU7U88D04I | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"QU7U88D04I"} |
| openFDA substances | FDA UNII substance identifier | WG3R46N0SV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"WG3R46N0SV"} |
| openFDA substances | FDA UNII substance identifier | 6HQ855798J | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6HQ855798J"} |
| openFDA substances | FDA UNII substance identifier | 002FR4N8OV | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"002FR4N8OV"} |