Reaction mass of calcium dihydroxide and calcium peroxide

Toxicity to reproduction

Administrative data

Endpoint:

three-generation reproductive toxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A three-generation drinking water study at 0 or 200 mg/kg bw/day Calcium Formate in the drinking water was performed in Wistar rats. The duration of the test was ca. 3 years. At the beginning of the test, 8 males and 24 females in the treated group, and 8 males and 8 females in the control group were used. Number, weight and length of offspring were examined. A portion of the offspring was also sacrificed shortly after birth for evaluation of developmental toxicity.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Calcium diformate

EC Number:

208-863-7

EC Name:

Calcium diformate

Cas Number:

544-17-2

IUPAC Name:

calcium diformate

Test animals

Species:

rat

Strain:

Wistar

Details on species / strain selection:

TEST ANIMALS
- Weight at study initiation: 160-200 g

Sex:

male/female

Administration / exposure

Route of administration:

oral: drinking water

Details on mating procedure:

No data.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

A three-generation study.

Frequency of treatment:

Daily

Doses / concentrations

Dose / conc.:

200 mg/kg bw/day (nominal)

No. of animals per sex per dose:

At the beginning of the test:
8 males and 24 females in the treated group
8 males and 8 females in the control group

Control animals:

yes

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

No effects on fertility (up to 3 generations) were observed.

Effect levels (P0)

Key result

Dose descriptor:

NOAEL

Effect level:

>= 200 mg/kg bw/day (nominal)

Basis for effect level:

other: No test item adverse effects observed at the highest dose tested.

Target system / organ toxicity (P0)

Key result

Critical effects observed:

no

Results: F1 generation

Details on results (F1)

Number, weight and length of offspring did not differ in treated animals from controls.
No statistical differences in organ or bone abnormalities were found.
The growth of treated offspring was similar to controls.

Effect levels (F1)

Key result

Dose descriptor:

NOAEL

Based on:

test mat.

Basis for effect level:

other: No test item related adverse effects observed.

Target system / organ toxicity (F1)

Key result

Critical effects observed:

no

Overall reproductive toxicity

Key result

Reproductive effects observed:

no

Applicant's summary and conclusion

Conclusions:

The NOAEL for maternal and developmental toxicity was equal or higher than 200 mg/kg bw/day.

Executive summary:

A three-generation drinking water study at 0 or 200 mg/kg bw/day Calcium Formate in the drinking water was performed in Wistar rats. The duration of the test was ca. 3 years. At the beginning of the test, 8 males and 24 females in the treated group, and 8 males and 8 females in the control group were used. No effects on fertility were observed. Number, weight and length of offspring did not differ in treated animals from controls.A portion of the offspring was also sacrificed shortly after birth for evaluation of developmental toxicity. No statistical differences in organ or bone abnormalities were found. The growth of treated offspring was similar to controls. The NOAEL for maternal and developmental toxicity was equal or higher than 200 mg/kg bw/day.