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Diss Factsheets

Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-04-06 - 1990-05-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This animal study is not performed according to GLP, but the test parameters are well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
EPTC
EC Number:
212-073-8
EC Name:
EPTC
Cas Number:
759-94-4
Molecular formula:
C9H19NOS
IUPAC Name:
N,N-dipropyl(ethylsulfanyl)formamide
Test material form:
other: granulates
Details on test material:
EPTC technikai batch number FL 604 purity : 97,22%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
4 weeks old SPF Wistar male and female rats were purchased from Laboratory Animals Institute. An acclimatisation period of at least 10 days was allowed before starting the study.
Temperature and relative humidity in the animal rooms were recorded daily and the records retained. The avarage values were 21+-3 c for temperature and 30-70% for relative humidity.
Study period: 1989-04-06 - 1990-05-30

Administration / exposure

Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
Three groups of SPF Wistar rats were dosed with EPTC technical dietary route through 2-generation inclusive at nominal dosage of 250, 500, 1000 mg/kg diet respectively. A fourth group (0 mg EPTC/kg) served as vehicle control.
Details on mating procedure:
A nőstényeket a hímekkel 2:1 arányban pároztatták. A pároztatást követő reggelen a nőstényekből vett hüvelykenetet mikroszkópikusan ellenőrizték. Az itt megállapított adatokat rögzítették és meghatározták a kopulációs arányt.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
The experimental diet EPTC content was controlled by batches using a GLC (gas chromatography) method described in Analytical methods for Pesticides and Plant Groth Regulators.
Duration of treatment / exposure:
1989-04-06 - 1990-05-30
Details on study schedule:
Szülői P0 generáció
- A kezelés időtartama és gyakorisága: Hím: naponta, legalább 10 héttel a pároztatás előtt az F1b újszülöttek elválasztásáig. Nőstény: naponta, legalább 10 héttel a pároztatás előtt az F1b utódok elválasztásáig.
- a kezelt csoportok nagysága: kielégítő, mintegy 20-20 vemhes nőstény elérése
-kontroll csoport nagysága: kielégítő, mintegy 20 vemhes nőstény elérése
- pároztatás: 1 hím: 2 nőstény maximum 10 napon keresztül
-boncolás ideje: hím: második pároztatást követően, nőstény az F2b újszülöttek elválsztását követően

Szülői F1 generáció
- A kezelés időtartama és gyakorisága: Hím: naponta, az elválasztástól a pároztatási periódus befejezéséig. Nőstény: naponta, az elválasztástól az F2b újszülöttek elválasztásáig.
- az állatok kiválasztása a pároztatáshoz: randomizáltan, mindegyik alomból
- csoportméretek: kielégítő mintegy 20 vemhes nőstény elérése
- az alom standardizálása: az almok nagysága 8 újszülöttre redukálva a születési napon.
- pároztatás ideje: a patkányok legalább 13 hetes korúk
- a boncolás ideje: hímeknél: a második pároztatást követően, nőstényeknél: a második, F2b újszülöttek elválasztását követően.

F2a és F2b almok:
- feldolgozás ideje: hímek: elválasztás után
nőstények: elválasztás után

A szülői párok és újszülöttek vizsgálatai mindegyik generációnál
- klinikai tünetek és mortalitás: naponta mindegyik állaton
- testsúly adatok P0 és P1: a kezelés első napján, majd azt követően hetente
- az újszülöttek száma és megjelenése: a született utódok számának rögzítése, az élve születettekn a makroszkópikus eltérések rögzítése
- kórboncolás: minden szülői állaton és utódon
- szövettan: a viszgálatra kerülő szervek reprodukciós és célszervek, P0, F1 és F1b és F2b állatoknál.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0
Basis:
nominal in diet
control group: 1-30 female, 121-135 male
Remarks:
Doses / Concentrations:
250 mg/kg
Basis:
nominal in diet
31-60 female, 136-150 male
Remarks:
Doses / Concentrations:
500 mg/kg
Basis:
nominal in diet
61-90 female, 151-165 male
Remarks:
Doses / Concentrations:
1000 mg/kg
Basis:
nominal in diet
91-120 female, 166-180 male
No. of animals per sex per dose:
30 females and 15 males / dose ( see the numbers at doses/concentrations above).
Control animals:
yes
Positive control:
no data

Examinations

Statistics:
A szülői tápfogyasztás és minden testtömeg adat Student-t próbával került elemzésre.
Offspring viability indices:
viability index calculated: number of pups live on day 4 of lactation/ number of live on day 0 of lactation

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
daily
Body weight and weight changes:
no effects observed
Description (incidence and severity):
recorded
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
recorded
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
recorded
Other effects:
no effects observed
Description (incidence and severity):
Test substance intake: recorded

Details on results (P0)

Histopathological studies on male rats ( P0, F1, F1b, F2b)
The following tissues from the control and treated parental animals and offsprings were routinely examined microscopically using hematoxylin-eosin method: lung, spleen, liver, kidneys, heart, testes, prostate, epididymis, seminal vesicles.

Histopathological studies on female rats ( P0, F1, F1b, F2b)
The following tissues from the control and treated parental animals and offsprings were routinely examined microscopically using hematoxylin-eosin method: lung, spleen, liver, kidneys, mammary gl., ovaries, uterus, vagina, heart

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 40 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: not spcified

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Description (incidence and severity):
recorded
Mortality / viability:
no mortality observed
Description (incidence and severity):
viability index calculation
Body weight and weight changes:
no effects observed
Description (incidence and severity):
recorded
Histopathological findings:
no effects observed
Description (incidence and severity):
recorded

Details on results (F1)

Copulation index, fertility index, gestation index, lactation index and viability index were calculated.

Histopathological studies on male rats ( P0, F1, F1b, F2b)
The following tissues from the control and treated parental animals and offsprings were routinely examined microscopically using hematoxylin-eosin method: lung, spleen, liver, kidneys, heart, testes, prostate, epididymis, seminal vesicles.

Histopathological studies on female rats ( P0, F1, F1b, F2b)
The following tissues from the control and treated parental animals and offsprings were routinely examined microscopically using hematoxylin-eosin method: lung, spleen, liver, kidneys, mammary gl., ovaries, uterus, vagina, heart

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 40 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Corresponding to the data evaluated from this study the 2-generation reproduction toxicity no observed effect level (NOEL) is more than 40 mg/kg animal/day.
Executive summary:

Three groups of SPF Wistar rats were dosed with EPTC technical dietary route through 2 -generation inclusive at nominal dosages of 250, 500, 1000 mg/kg diet respectively. A fourth group served as vehicle control.

Summarizing the results of the 2 -generation reproduction toxicity study the following items can be conluded:

There were not any test material related clinical signs and mortality during the 2 -generation reproduction toxicity study.

The applied dose-levels have not affected the food consumption habits of the test animals.

The applied doses have not caused considerable alteration in food consumption data, in body weight and body weight gain, of treated animals compared to control.

The nominal doses in diet were 0, 250, 500, 1000 mg/kg which were corrected by the analytical control of diet. On this basis and taking into consideration the food consumption data the following active ingredient intakes were calculated ( mg/kg animal/day

P0 generation: 0, 8,8, 18.0, 39.2

F1 generation: 0, 8,8, 18.2, 39.0

There was not any dose-response effect found at any dose-level and generation at necropsy.

The histopathological study have not shown any test material related characteristic histomorphological change in the treated groups during the 2 -generation.

Due to the calculated reproductional indices there were not significant differences in copulation, fertility, gestation, lactation, viability parameters of treated groups compared to the control data in both P0 and F1 generation.

During the study there was not any indication for the possible teratognomic potential of test material EPTC technical.

Corresponding to the data evaluated from this study the 2-generation reproduction toxicity no observed effect level (NOEL) is more than 40 mg/kg body weight/day.