USA EPA Original Studies on Reproductive & Developmental Toxicity of Glyphosate: studies only supplied by one (1) chemical company (Monsanto).

Untitled_013NOTE: The EPA’s decision for maximum levels in America’s food is based on a 60gk adult, not upon the most vulnerable members of our community, the pregnant mother and the developing foetus.

The EPA’s science, for regulating glyphosate (commonly known as Roundup), which was last revised 09/01/1990 , says these are the studies for the EPA coming to the recommended minimum (residual) amount of glyphosate in food.

Safe Says Who is looking for the studies put forward to evaluate the reproductive and developmental toxicity (Ie. how damaging glyphosate (Roundup) is to the pregnant mother and developing foetus/fetus):

On the EPA database the glyphosate reference  number is CASRN 1071-83-6

I.  Chronic Health Hazard Assessments for Noncarcinogenic Effects

You can look at the originals on EPA IRIS .

I.A.4. Additional Studies/Comments (Oral RfD) Last revised:  09/01/1990

1)  Developmental Toxicity:  Tasker, E.J. and Rodwell, D.E. 1980: Teratology study in rats: Dose levels tested: 0, 300, 1000 and 3500 mg/kg/day; Groups of pregnant Charles River COBS CD rats (25/dose) were administered glyphosate orally by gavage as a single daily dose on days 6 through 19 of gestation. A definite reduced mean maternal body weight gain was noted in the 3500 mg/kg/day dose group over the treatment period due to mean maternal body weight loss during the first 3 days of treatment. At 3500 mg/kg/day a statistically significant increase in the mean number of early resorptions resulted in a slight increase in mean postimplantation loss. A statistically significant decrease in the mean number of total implantations, viable fetuses, and mean fetal body weight and a slight decrease in the mean number of corpora lutea was noted in this group. Based on these findings, the NOEL and LEL for maternal toxicity are 1000 and 3500 mg/kg/day, respectively. An increase in the number of litters and fetuses with unossified sternebrae was noted in the 3500 mg/kg/day dose group. Based on this finding, the NOEL and LEL for developmental toxicity are 1000 and 3500 mg/kg/day, respectively; core grade minimum (Monsanto Co., 1980a,  MRID 00046362) [1]

2)  Developmental Toxicity:  Rodwell, D.E.; Tasker, E.J.; Blair, M.; et al. (1980): Teratology Study in Rabbits. Dose levels tested: 0, 75, 175, and 350 mg/kg/day; Groups of pregnant Dutch Belted rabbits (16/dose) were administered glyphosate orally by gavage as a single daily dose on days 6 through 27 of gestation. A slight increase in the incidence of soft stools and diarrhoea was noted in the 175 mg/kg/day group and a definite increase in these signs and nasal discharge were noted in the 350 mg/kg/day group. Based on these findings, the NOEL and LEL for maternal toxicity are 175 and 350 mg/kg/day, respectively. No developmental toxicity effects were noted at any dose tested. Therefore, the NOEL for developmental toxicity is equal to or greater than 350 mg/kg/day; core grade minimum (Monsanto Co., 1980b,  MRID 00046363) [2]

NOTHING FOR REPRODUCTIVE TOXICITY……..

Safe Says Who note: To find other studies considered by the EPA we go back to the science of the original 1993 document, the Reregistration Eligibilty Decision, RED, the piece that pulled it all together at the start.  Note that Developmental Toxicity is the same as above, but also listed is Reproductive Toxicity.  One Study says go really low.  The next says go really high and ignore the low study.

The above study(MRID 00046363) is the study that sets the ADI (or referred to in the USA as the reference dose for glyphosate.  It is not GLP,  and it is unpublished.

Reregistration Eligibility Decision     (Page 15)

e. Developmental Toxicity (same as above, you can see from the MRID numbers):

1)  A developmental toxicity study was conducted with pregnant Charles River COBS CD rats which were administered 0, 300, 1000 or 3500 mg/kg/day of glyphosate by gavage during gestation days 6 through 19.  Treatment-related effects observed only in the highdose dams included:  (1) diarrhea; (2) decreased mean body weight gain; (3) breathing rattles; (4) inactivity; (5) red matter around thenose and mouth, and on forelimbs and dorsal head; (6) decreases in total implantations/dam and inviable foetuses/dam; and (7) deaths (6/25 or 24% of the group).  Treatment-related developmental effects observed only in the high-dose group included:  (1) increased number of litters and foetuses with unossified sternebrae; and (2) decreased mean fetal body weights.  Therefore, the NOEL and LOEL for maternal toxicity are 1000 mg/kg/day and 3500 mg/kg/day,respectively.  The NOEL and LOEL for developmental toxicity are 1000 mg/kg/day and 3500 mg/kg/day, respectively.  (MRID 00046362)  Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980) Unpublished  [1]

2)  In a second Develomental Toxicity study, pregnant Dutch Belted rabbits were administered 0, 75, 175 or 350 mg/kg/day of glyphosate by gavage during gestation days 6 through 27.  Treatment-related findings were observed only in the high-dose group and included:  (1) diarrhoea; (2) nasal discharge; and (3) death (10/16 or 62.5% of does died by gestation day 21).  Developmental toxicity was not observed at any dose tested.  Therefore, the NOEL and LOEL for maternal toxicity are 175 mg/kg/day and 350 mg/kg/day, respectively.  The NOEL for developmental toxicity is 175 mg/kg/day.  Due to high maternal mortality at the 350 mg/kg/day dose level, too few litters (only 6) were available to assess adequately developmental toxicity at that level.  (MRID 00046363 Tasker, 1980b, Unpublished) [2]

f.  Reproductive Toxicity

1)  Street, R. (1982): A reproduction study was conducted with male and female Sprague-Dawley rats which were administered 0, 3, 10 or 30 mg/kg/day of glyphosate continuously in the diet for three successive generations.  The only effect observed was an increased incidence of focal tubular dilation of the kidney (both unilateral and bilateral combined) in the high-dose male F3b pups.  Therefore, the NOEL for systemic and reproductive toxicity is 30 mg/kg/day (HDT).  The NOEL and LOEL for developmental toxicity are 10 mg/kg/day and 30 mg/kg/day, respectively.  (MRID 00105995 Street, R. (1982) Unpublished) [3]

2)  Reyna, M. (1990) :Another reproduction study was conducted with SpragueDawley rats which were administered 0, 100, 500 or 1500mg/kg/day of glyphosate continuously in the diet for two successive generations.  Treatment-related effects observed only in the highdose group included:  (1) soft stools, very frequent, in the Fo and F1males and females; (2) decreased food consumption and bodyweight gain of the Fo and F1 males and females during the growth(premating) period; and (3) decreased body weight gain of the F1a, F2a and F2b male and female pups during the second and third weeks of lactation.  Focal tubular dilation of the kidneys, observed in the previous study (00105995), was not observed at any dose level in this study.  Based on the above findings, the systemic NOEL and LOEL are 10000 ppm (500 mg/kg/day) and 30000 ppm (1500mg/kg/day), respectively.  The reproductive NOEL is 30000 ppm (1500 mg/kg/day; HDT); and the developmental NOEL and LOEL are 10000 ppm (500 mg/kg/day) and 30000 ppm (1500 mg/kg/day), respectively.  (MRID 41621501, Reyna, M. (1990) Unpublished) [4]

Since the focal tubular dilation of the kidneys was not observed at the 1500 mg/kg/day level (HDT) in the 2-generation rat reproduction study but was observed at the 30 mg/kg/day level (HDT) in the 3-generation rat reproduction study (00105995 Street R. 1982), the Agency concluded that the latter was a spurious rather than glyphosate-related effect.

Safe Says Who note: So the second study completely pulls the first, at massively different rates of this chemical in the diet, and the EPA accepts that a different, enormously higher dose is fine?

REFERENCES

Developmental Toxicity

[1]  Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980): Teratology Study in Rats: IRDC No. 401-054. MRID 00046362 (Unpublished study including IRDC no. 999-021; received May 23, 1980 under 524-308; prepared by International Research and Development Corp., submitted by Monsanto Co., Washington, D.C.; CDL:242516-A)

[2]  Rodwell, D.E.; Tasker, E.J.; Blair, M.; et al. (1980b): Teratology Study in Rabbits: IRDC No. 401-056. MRID 00046363  (Unpublished study received May 23, 1980 under 524-308; prepared by International Research and Development Corp., submitted by Monsanto Co., Washington, D.C.; CDL:242516-B)

Reproductive Toxicity

[3]  Street, R. (1982): Letter sent to R.Taylor dated Jul 6, 1982:  Roundup herbicide: Addendum to pathology report for a three-generation reproduction study in rats with glyphosate. MRID 00105995  (Unpublished study received Jul 7, 1982 under 524-308; submitted by Monsanto Co., Washington, DC; CDL:247793-A)

[4]  Reyna, M. (1990): Two Generation Reproduction Feeding Study with Glysophate in Sprague-Dawley Rats: Lab Project No: MSL-10387. MRID 41621501 Unpublished study prepared by Monsanto Agricultural Co.  1158

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