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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
three-generation reproductive toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from review article

Data source

Reference
Reference Type:
publication
Title:
Reproductive toxicity study of the test chemical
Author:
WHO
Year:
1974
Bibliographic source:
WHO technical Report Series 1000, 2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Three generation reproductive toxicity study was performed to determine the toxic nature of the test chemical
GLP compliance:
not specified
Limit test:
no
Justification for study design:
No data

Test material

Constituent 1
Chemical structure
Reference substance name:
1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
EC Number:
305-897-5
EC Name:
1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
Cas Number:
95193-83-2
Molecular formula:
C18H11NO5S to C18H8NO11S3.3Na
IUPAC Name:
trisodium hydrogen bis(2-(1,3-dioxo-5-sulfonato-2,3-dihydro-1H-inden-2-yl)quinoline-8-sulfonate)
Details on test material:
- Name of the test chemical: 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- Molecular formula: C18H9NNa2O8S2
- Substance type: Organic

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: Feed
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 0, 0.5, 5.0, 15.0, 50 mg/kg bw

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
Details on mating procedure:
No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
For 3 generations
Frequency of treatment:
Daily
Details on study schedule:
No data
Doses / concentrations
Remarks:
0, 0.5, 5.0, 15.0, 50 mg/kg bw
No. of animals per sex per dose:
0 mg/kg bw: 60 males and 60 females
0.5 mg/kg bw: 60 males and 60 females
5.0 mg/kg bw: 60 males and 60 females
15.0 mg/kg bw: 60 males and 60 females
50 mg/kg bw: 60 males and 60 females
Control animals:
yes, concurrent vehicle
Details on study design:
No data
Positive control:
No data

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Mortality

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data

BODY WEIGHT: Yes
- Time schedule for examinations: No data

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data

OTHER: No data
Oestrous cyclicity (parental animals):
No data
Sperm parameters (parental animals):
No data
Litter observations:
Pup survival and pup body weight was noted
Postmortem examinations (parental animals):
Gross and histopathology was performed but details are not specified
Postmortem examinations (offspring):
No data
Statistics:
No data
Reproductive indices:
Pregnancy or fertility rates, reproductive parameters, including numbers of embryos, corpora lutea and resorptions were observed
Offspring viability indices:
Pup survical was noted

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Dermal irritation (if dermal study):
not specified
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
Pregnancy or fertility rates, reproductive parameters, including numbers of embryos, corpora lutea and resorptions were not affected by treatment

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw (total dose)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment related effects were observed

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: P1 (second parental generation)

General toxicity (P1)

Clinical signs:
no effects observed
Dermal irritation (if dermal study):
not specified
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Other effects:
not specified

Reproductive function / performance (P1)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
Pregnancy or fertility rates, reproductive parameters, including numbers of embryos, corpora lutea and resorptions were not affected by treatment

Effect levels (P1)

Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw (total dose)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment related effects were observed

Target system / organ toxicity (P1)

Critical effects observed:
not specified

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Anogenital distance (AGD):
not specified
Nipple retention in male pups:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Description (incidence and severity):
No gross abnormalities were noted in the rats of the F1b generation that could be attributed to the test chemical treatment
Histopathological findings:
no effects observed
Description (incidence and severity):
No histological abnormalities were noted in the tissues of rats of the F1b generation that could be attributed to the test chemical treatment
Other effects:
no effects observed

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not specified

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1b
Effect level:
50 mg/kg bw (total dose)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment related effects were noted

Target system / organ toxicity (F1)

Critical effects observed:
not specified

Results: F2 generation

General toxicity (F2)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Anogenital distance (AGD):
not specified
Nipple retention in male pups:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified

Developmental neurotoxicity (F2)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F2)

Developmental immunotoxicity:
not specified

Target system / organ toxicity (F2)

Critical effects observed:
not specified

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
The no observed adverse effect level (NOAEL) for the test chemical using rats in a 3 generation reproductive toxicity study was observed to be 50 mg/Kg bw/day.
Executive summary:

Three generation reproductive toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using rats. The test chemical was mixed with feed at dose level of 0, 0.5, 5.0, 15.0, 50 mg/kg bw / day and exposed to the animals for 3 generations. The treated parental animals and pups were observed for parental mortality, body weight, feed consumption, mating, pregnancy or fertility rates, pup survival, pup body weight, reproductive parameters, including numbers of embryos, corpora lutea and resorptions, or necropsy findings. No treatment related effects were observed on parental rats or pups. No compound-related effects on parental mortality, body weight, feed consumption, mating, pregnancy or fertility rates, pup survival, pup body weight, reproductive parameters, including numbers of embryos, corpora lutea and resorptions, or necropsy findings were observed. No gross or histological abnormalities were noted in the tissues of rats of the F1b or F3a generation that could be attributed to test chemical treatment. Based on the details of the study, the no observed adverse effect level (NOAEL) for the test chemical using rats in a 3 generation reproductive toxicity study was observed to be 50 mg/Kg bw/day.