Registration Dossier
Registration Dossier
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EC number: 205-447-7 | CAS number: 141-01-5
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 authoritative database
Data source
Reference
- Reference Type:
- other: Authoritative database
- Title:
- Toxicology directory for the test chemical
- Author:
- Commission on Standards, Fairness, Health and Safety at Work, CANADA
- Year:
- 2 000
- Bibliographic source:
- Commission on Standards, Fairness, Health and Safety at Work, CANADA, 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Iron(II) fumarate
- EC Number:
- 205-447-7
- EC Name:
- Iron(II) fumarate
- Cas Number:
- 141-01-5
- Molecular formula:
- C4H4O4.Fe
- IUPAC Name:
- iron(II) fumarate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Ferrous fumarate
- Molecular formula: C4H4O4.Fe
- Molecular weight : 169.901 g/mol
- Smiles notation : [Fe+2].[O-]C(\C=C\C(=O)[O-])=O
- InChl : 1S/C4H4O4.Fe/c5-3(6)1-2-4(7)8;/h1-2H,(H,5,6)(H,7,8);/q;+2/p-2/b2-1+;
- Substance type:Organic
- Physical state:Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- no data available
- Details on mating procedure:
- no data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- day 6 to day 15 of gestation
- Frequency of treatment:
- daily
- Details on study schedule:
- no data availabler
Doses / concentrations
- Remarks:
- 2-200 mg/kg
- No. of animals per sex per dose:
- no data available
- Control animals:
- not specified
- Details on study design:
- no data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Mortality:
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- did not result in embryotoxic or fetal effects or congenital malformations.
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):
- The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- 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:
- no effects observed
- Description (incidence and severity):
- The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
- Executive summary:
A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
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