Iron sinter

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Remarks:

Abstract in English language only

Data source

Reference

Reference Type:

publication

Title:

Teratogenicity studies of Slow-Fe in mice and rats

Author:

Tadokoro, T. et al.

Year:

1979

Bibliographic source:

Oyo Yakuri 17 (3): 483 - 495

Materials and methods

Principles of method if other than guideline:

The influence of iron sulfate (Slow Fe) on the foetuses and offspring of pregnant mice was studied. The mice were dosed p.o. once a day for 6 consecutive days. The dosages were 0, 120, 380 and 1200 mg/kg/day.

Limit test:

no

Test material

Test material information

Test animals

Species:

mouse

Administration / exposure

Details on exposure:

Pregnant mice were dosed p.o. once a day for 6 consecutive days.

Duration of treatment / exposure:

6 consecutive days (gestation days: 7 to 12)

Frequency of treatment:

once a day

Duration of test:

at least 61 days

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

120 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

380 mg/kg bw/day

Doses / concentrations 3

Dose / conc.:

1 200 mg/kg bw/day

No. of animals per sex per dose:

at least 15 pregnant females

Control animals:

yes

Details on study design:

A pilot study was conducted in female mice. The mice received 0, 300, 600 and 1200 mg/kg/day of the test item via oral administration. No mortality was observed during a two week observation period. The body weight was also determined during the observation period.

Examinations

Maternal examinations:

BODY WEIGHT CHANGE: Yes
- Time schedule for examinations: each day during gestation and at birth as well as on lactation days 7, 14 and 21.

Ovaries and uterine content:

For the following examinations 15 dams were investigated at term:
The uterine content was examined after termination: Yes
Examinations included:
- Number of implants (% of implants)
- Number of dead implants
- Number of litters
- Number of dams without live foetuses

For the following examinations 5 dams were investigated after birth:
- Number of litters
- Length of gestation period
- Number and percentage of implantation sites

Fetal examinations:

For the following examinations 15 litters were investigated at term:
- External examinations: Yes, all foetuses
- Soft tissue examinations: Yes, half of all foetuses
- Skeletal examinations: Yes, half of all foetuses

- Number of live male and female foetuses
- Sex ratio was determined.
- mean body weight at term.

For the following examinations 5 litters were investigated after birth:
- Mean body weight change of male and female offspring on lactation day 0, 7, 14 , 21, 28, 35 and 42.
- Number of delivered foetuses (male/female, stillborn).
- Number of surviving offsprings on lactation days 0, 7, 14, 21, 28, 35 and 42 days (% of delivered foetuses).
- Developmental index of offspring was determined after birth.
- Number sexual matured male and female offspring (% of survived offspring)
- Number of Preyer's reflex (% of survived offspring)

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Details on results:

The results of the present experiment showed no influence on survival of dams.

Please also refer to the field "Attached background material".

Effect levels (maternal animals)

Remarks on result:

other: The results of the present experiment showed no influence on survival of dams.

Results (fetuses)

Details on embryotoxic / teratogenic effects:

The teratogenicity was not revealed by dosing of the test item in mice in the present experiment.

Please also refer to the field "Attached background material".

Effect levels (fetuses)

Remarks on result:

other: The teratogenicity was not revealed by dosing of the test item in mice in the present experiment.

Applicant's summary and conclusion

Conclusions:

According to the authors, the results of the present experiment showed no influence on survival of dams. Furthermore, the teratogenicity was not revealed by dosing of the test item in mice in the present experiment. However, no conclusion can be drawn for this publication, since the reference is written in Japanese language and an abstract in English language is only available, which does not allow a review of the study. Furthermore, the number of dams per group is too low and the exposure duration is too short.