Registration Dossier
Registration Dossier
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EC number: 201-321-0 | CAS number: 81-07-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 peer reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Effects on mouse embryos of in utero exposure to saccharin: teratogenic and chromosome effects
- Author:
- R. H. Dropkin*, D. F. Salo, S. M. Tucci, and G. I. Kaye
- Year:
- 1 984
- Bibliographic source:
- Arch. Toxicol. 1984, 56(4), 283.
- Reference Type:
- review article or handbook
- Title:
- DOSE doc.no. : S1
- Author:
- RSC Publishing
- Year:
- 2 011
- Bibliographic source:
- The Dictionary of Substances and their Effects;Drophkin, R. H. et al Arch. Toxicol. 1984, 56(4), 283.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Teratogenic effects of Saccharin in mouse
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- EC Number:
- 201-321-0
- EC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Cas Number:
- 81-07-2
- Molecular formula:
- C7H5NO3S
- IUPAC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Details on test material:
- - Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Substance type: Organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: ICR albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:(Camm Research Institute, Wayne, NJ)
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Concentration in vehicle: 0, 5, 10 or 20% solution
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Details on exposure
PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Concentration in vehicle: 0, 5, 10 or 20% solution
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: No data available
- Length of cohabitation: No data available
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: No data available
- After … days of unsuccessful pairing replacement of first male by another male with proven fertility: No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)]: No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Frequency of treatment:
- Daily
- Duration of test:
- 18 days, i.e. from day 0 through day 17 of pregnancy
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 10 or 20% (0, 500, 1000, 2000 mg/Kg bw)
Basis:
- No. of animals per sex per dose:
- Total: 25 females
Control: 10 females
5%: 5 females
10%: 5 females
20%: 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- All dams were killed by cervical dislocation on day 17 and fetuses removed and examined.
- Ovaries and uterine content:
- The number of resorptions was observed.
- Fetal examinations:
- Fetuses were removed from maternal uteri and were examined for gross internal and external malformations. Externally, limbs, back, facies, and head were inspected for gross malformations. Internally, the palate, brain, heart, lungs, kidneys, bladder, gut, and gonads were examined for gross anomalies.
- Statistics:
- No data available
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Maternal uteri examined for fetal resorption showed no significant increase compared with dams who received no saccharin.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
None of the fetuses from dams treated with saccharin showed significant increases in either external or internal malformations when compared to controls.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 2000 mg/kg bw in female ICR albino mice and their offspring when they the pregnant females were exposed to saccharin
- Executive summary:
In a teratogenicity study, the toxic effects of saccharin was evaluated in pregnant female ICR albino mice. The dams received saccharin in drinking water at a dosage of 0, 500, 1000 or 2000 mg/kg bw from day 0 to day 17 of gestation. The results showed no significant increase for fetal resorption in the maternal uteri as compared with dams who received no saccharin. None of the fetuses from dams treated with saccharin in drinking water showed significant increases in either external or internal malformations when compared to control. Therefore, NOAEL was considered to be 2000 mg/kg bw in the maternal F0 generation and in the F1 generation after administration of saccharin in drinking water from day 0 to day 17 of gestation.
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