Registration Dossier
Registration Dossier
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EC number: 231-843-4 | CAS number: 7758-94-3
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1d The study was well documented and meets generally accepted scientific principles, and conducted in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 7782-63-0
- EC Number:
- 616-510-7
- Cas Number:
- 7782-63-0
- IUPAC Name:
- 7782-63-0
- Reference substance name:
- Iron (II) sulfate heptahydrate
- IUPAC Name:
- Iron (II) sulfate heptahydrate
- Details on test material:
- - Name of test material (as cited in study report): Iron (II) sulfate heptahydrate
- Physical state: blue-green crystalline powder
- Analytical purity: 91.1% (Lot No. 010628) and 90.6% (Lot No. 010903)
- Impurities (identity and concentrations): Mg 0.3%, Mn 0.19%, Zn 75 ppm (Lot No. 010628) and Mg 0.28%, Mn 0.16%, Zn 84 ppm (Lot No. 010903)
- Storage condition of test material: room temperature under argon
- Stability under test conditions: The stability of test concentrations was confirmed for 6 hours in the dark at room temperature.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 10 weeks
- Weight at study initiation: male: 341 -383 g; female: 222 -255 g
- Housing: stainless steel cage
- Diet (ad libitum): CRF-1 from Oriental Yeast Co., Ltd.
- Water (ad libitum): tap water
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 40 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test substance was prepared with water for injection purposes. Gavage solutions were prepared freshly each time and used within 6 hours.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations were measured in samples used for males at the first teatment and at the end of administration.
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: up to 14 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Males: Total of 49 days beginning 14 days before mating.
Females: Total of 42-47 days beginning 14 days before mating. - Frequency of treatment:
- Once daily
- Duration of test:
- 49 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100, 300, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses selected for the main studies were based on gross pathology findings observed in the 14-days preliminary studies (Study No. 100520P).
Examinations
- Maternal examinations:
- Observation performed and frequency: General condition was observed twice a day (before and after treatment).
Male body weights were measured twice a week. Female body weights were measured twice a week during the pre-mating and mating period and on days 0, 7, 14 and 21 of gestation and days 0 and 4 of lactation.
Food consumption was determined twice a week during the pre- and post-mating period in males, and twice a week during the pre-mating period and on days 2, 9, 16 and 21 of gestation and day 4 of lactation in females.
For 6 males and females per group, urinalysis was carried out before final administration.
Blood samples were collected from the abdominal aorta on next day of the last administration and hematological and blood chemical examinations were carried out. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No
- Number of late resorptions: No - Fetal examinations:
- - External examinations: Yes:
- Soft tissue examinations: No data
- Skeletal examinations: No data
- Head examinations: No data - Statistics:
- Bartlett´s test, Dunnett´s test and ?2 test
- Indices:
- copulation index, fertility index, gestation index, delivery index, implantation index, live birth index and viability index
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
See section 7.5.1, for details of parental toxicity.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (actual dose received)
- Based on:
- element
- Remarks:
- Fe
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 200 mg/kg bw/day
- Based on:
- element
- Remarks:
- Fe
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a well conducted OECD 422 study conducted to GLP (reliability score 1), the NOAEL for developmental toxicity was at least 1000 mg/kg bw/day iron sulphate heptahydrate (equivalent to 200 mg/kg bw/day iron) in rats. The NOAEL for parental toxicity was 100 mg/kg bw/day (equivalent to 20 mg/kg bw/day iron).
- Executive summary:
In a well conducted OECD 422 study conducted to GLP (reliability score 1), the NOAEL for developmental toxicity was at least 1000 mg/kg bw/day iron sulphate heptahydrate (equivalent to 200 mg/kg bw/day iron) in rats. The NOAEL for parental toxicity was 100 mg/kg bw/day (equivalent to 20 mg/kg bw/day iron).
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