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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium triphosphate
EC Number:
231-838-7
EC Name:
Pentasodium triphosphate
Cas Number:
7758-29-4
Molecular formula:
H5O10P3.5Na
IUPAC Name:
pentasodium triphosphate
Details on test material:
- Name of test material (as cited in study report): FDA 71-46 (sodium tripolyphosphate; anhydrous)
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
Dutch
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: mesh bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- Impregnation procedure: artificial insemination
Duration of treatment / exposure:
12 days
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 2.5, 11.6, 54, 250 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
20
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 12, 18 and 29 of gestation

POST-MORTEM EXAMINATIONS: No data
Ovaries and uterine content:
he ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
Fetal examinations:
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: No data
Statistics:
No data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:not examined

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
The number of abnormalities seen in either soft or skeletal tissues of the test group did not differ from the number occurring spontaneously in the sham treated control

Effect levels (fetuses)

Dose descriptor:
NOEC
Effect level:
250 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Reproduction data

Dose (mg/kg)

0

Positive control*

2.5

11.6

54

250

Pregnancy

Total no

15

13

16

15

16

13

Died or aborted

5

2

1

3

8

1

To term

10

11

15

12

14

12

Total corpora lutea

216

166

227

242

263

200

Average corpora lutea

10.8

9.76

11.4

12.1

12.0

9.52

Total live litters

8

8

14

12

14

10

Average implant site no

6.20

4.91

5.13

6.08

5.71

5.33

Resorptions

Percent partial resorptions

50.0

72.7

26.7

16.7

50.0

50.0

Percent complete resorptions

10.0

27.3

6.67

-

-

16.7

Average live foetus

4.7

3.73

4.27

5.42

5.07

4.42

Sex ratio (m/f)

1.35

1.16

1.29

1.16

1.29

0.83

Dead foetuses

6

1

4

-

1

-

Percent partial dead

10.0

9.09

13.3

-

7.14

-

percent all dead

10.0

-

-

-

-

-

Average foetus weight (g)

37.2

33.5

41.8

39.7

41.0

38.9

*2.5 mg/kg 6-aminonicotinamide dosed on day 9

Summary of skeletal findings

Dose (mg/kg)

0

Positive control

2.5

11.6

54.0

250

Sternebrae

Incomplete oss

-

6/2

-

-

4/3

-

Bipartite

-

-

-

-

1/1

-

Fused

-

10/5

6/3

1/1

2/2

1/1

Extra

2/2

1/1

-

2/2

3/3

2/1

missing

-

1/1

-

-

1/1

-

Ribs

Fused/split

-

13/6

-

-

-

-

Vertebrae

Scrambled

-

16/6

-

-

-

-

Scoliosis

-

13/6

-

-

-

-

Tail defects

1/1

35/8

-

-

1/1

-

Skull

Incomplete closure

-

1/1

-

-

-

-

(number of foetuses effected/number of litters)

Soft tissue abnormalities were only observed in the positive control group

Applicant's summary and conclusion

Conclusions:
The administration of up to 250 mg/kg bw/day of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham treated controls.
It is therefore concluded that sodium tripolyphosphate is not a teratogen for the rabbit