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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
three-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from authoritative source
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
method details not mentioned in the publication
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
Long-Evans
Sex:
male/female
Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on mating procedure:
No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 weeks before the first mating and dosing continued throughout the gestation, lactation, and post-weaning phases for three successive generations.
Frequency of treatment:
Daily
Details on study schedule:
The F0 generation rats were mated twice. The F0 generation rats were mated twice, the F1a litters being necropsied and F1b litters were used for breeding. Animals from the F1b generation were mated 3 times and the offspring of the F2a and F2b generations were treated identically to the F1a and F1b generations.In third mating half of the pregnant dams were sacrificed on day 19 of gestation and other half were allowed to deliver normally (F2c) and sacrificed at weaning. The F2b animals were mated once and allowed to raise their offspring to weaning.
Remarks:
Doses / Concentrations:0, 10, 100, 300, or 1,000 mg/kg b.w./dayBasis:nominal in diet
No. of animals per sex per dose:
Total :1500 mg/kg bw/day: 10 male, 20 female 10 mg/kg bw/day: 10 male, 20 female100 mg/kg bw/day: 10 male, 20 female300 mg/kg bw/day: 10 male, 20 female1000 mg/kg bw/day: 10 male, 20 female
Control animals:
yes, concurrent vehicle
Parental animals: Observations and examinations:
Parental animals observation and examinationsCAGE SIDE OBSERVATIONS: Yes - Time schedule: No data available- Cage side observations checked in table [No.?] were included.: Observations were also done to record any adult mortality.
Litter observations:
Survival, weights and sex were observed
Postmortem examinations (parental animals):
Postmortem examinations (Parent Animal)SACRIFICEThe F1a and F2c litters being necropsied at weaning.F1a and F1b, Following the third mating, half of the pregnant dams were sacrificed on day 19 of gestation.The F2b animals were mated once and allowed to raise their offspring to weaning when both parents and offspring were culled.GROSS NECROPSY- Gross necropsies were performed on F1a, F2a, and F2c
Postmortem examinations (offspring):
SACRIFICEF3a generation at weaning was fixed at necropsy.GROSS NECROPSY- Gross necropsies were performed on F3a offspring at weaning. HISTOPATHOLOGY were performed on all parent animals. Selected tissues from 5 animals of each sex/dose from the F1b parents were fixed at necropsy and tissues examined histologically from the control group and high-dose group.Organ examined: Stomach, ileum, jejunum, colon, liver, spleen, heart, lungs, adrenals, kidneys, urinary bladder, thyroid, ovaries, and uterus or testes were examined. Total embryos/resorption sites, and the corpora lutea per ovary were recorded
Reproductive indices:
Mating performance, pregnancy and fertility rates, gestation length and resorption rates were examined.
Offspring viability indices:
Yes
Clinical signs:
no effects observed
Description (incidence and severity):
Mortality: No effect were observed on survival of treated rat as compared to control.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effect were observed on body weight of treated rat as compared to control.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No effect were observed on body weight of treated rat as compared to control.
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No macroscopic or microscopic tissue abnormalities were observed in treated rat as compared to control.
Other effects:
not specified
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
not specified
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects were observed on survival, food consumption, body weight, mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival, resorption rates, gross pathology and histopathology
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects were observed on food consumption, body weight, adult mortality, offspring survival, weights and sex, litter survival, gross pathology and histopathology
Remarks on result:
other: Generation: F3 (migrated information)
Clinical signs:
not specified
Mortality / viability:
no mortality observed
Description (incidence and severity):
No effect were observed on offspring survival of treated rat as compared to control.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effect were observed on offspring body weight of treated rat as compared to control
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Description (incidence and severity):
No gross pathological changes were observed in treated offspring.
Histopathological findings:
no effects observed
Description (incidence and severity):
No macroscopic or microscopic tissue abnormalities were observed in treated offspring as compared to control
Reproductive function: estrous cycle of offspringsNo effect were observed on mating performance and pregnancy of treated offspring.
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects were observed on survival, food consumption, body weight, mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival, resorption rates, gross pathology and histopathology
Reproductive effects observed:
not specified
Conclusions:
NOAEL was considered to be 1000 mg/kg body weight /day when Long-Evans male and female rat treated with Fast Green FCF.
Executive summary:

In a 3-generation reproductive toxicity study,Long-Evans male and female rat treated with Fast Green FCF in the concentration of 0, 10, 100, 300 and 1,000 mg/kg b.w. /day orally in diet. No effect were observed onsurvival, food consumption and body weight of F1, F2 and F3 generation treated male and female rat. Similarly, no effect were observed on mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival and resorption rates of F1, F2 and F3 generation treated male and female rat. In addition,No gross pathological changes and macroscopic or microscopic tissue abnormalitieswere observed inF1, F2 and F3 generation treated male and female rat.

Therefore,NOAEL was considered to be1000 mg/kg body weight /daywhen Long-Evans male and female rat treated with Fast Green FCF orally in diet.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Data is from peer reviewed journal
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Studies of Fast Green FCF were reviewed for toxicity to reproduction from reliable sources having Klimisch rating 2

The summary of the results are presented below:

Sr. No

End point

Value

Species

Route

Effects

Remarks
1.

NOAEL

1000 mg/ kg bw/ d

Rat

Oral: feed

No effects were observed on survival, food consumption, body weight, mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival, resorption rates, gross pathology and histopathology

Experimental data for target chemical
2.

 LOAEL

 

17 mg/ kg bw/ d

Mouse

Oral: feed

Adverse effect on body weight, organ weight, histopathology and reproductive function

Experimental data for target chemical

               

Based on the studies summarized in the above table it can be observed that the NOAEL value in rats is found to be 1000 mg/kg bw /day whereas the LOAEL value in mice is 17 mg/kg bw/ d.


Short description of key information:
NOAEL was considered to be 1000 mg/kg body weight /day when Long-Evans male and female rat treated with Fast Green FCF whereas LOAEL was considered to be 0.017 g/kg body weight /day (17 mg/kg body weight /day) when B-6 Swiss albino male mice treated with Fast Green FCF.

Justification for selection of Effect on fertility via oral route:
NOAEL was considered to be 1000 mg/kg body weight /day when Long-Evans male and female rat treated with Fast Green FCF.

Justification for classification or non-classification

Additional information