Sodium dihydrogenorthophosphate

Toxicity to birds

Administrative data

Endpoint:

long-term toxicity to birds: reproduction test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data

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:

Toxicity and teratogenicity of food additive chemicals in the developing chicken embryo.

Author:

Verrett, MJ, Scott WF, Reynaldo EF, Alterman EK & Thomas CA.

Year:

1980

Bibliographic source:

Toxicology and Applied Pharmacology 56: 265 - 273.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: No data

Deviations:

not specified

Principles of method if other than guideline:

The toxicity of 80 chemicals used as food additives were investigated by their administration to developing chicken embryos. Four test conditions were used: Injection via the air cell and via the yolk; and at two times, preincubation (0 h) and 96 h. For each condition, at least 100 embryos per dose level were treated at a minimum of five dose levels. Appropriate groups of vehicle controls and untreated controls were included in all experiments. LD50 values were determined for each test condition. All embryos and hatched chicks were examined grossly for any abnormalities in development, both functional and structural. All abnormalities were tabulated and compared with values for the vehicle controls to determine teratogenicity. Levels tested ranged from 0.5 to 75 mg/egg; the maximum volume injected was 100 μL.

GLP compliance:

no

Remarks:

Study pre-dates GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dihydrogenorthophosphate

EC Number:

231-449-2

EC Name:

Sodium dihydrogenorthophosphate

Cas Number:

7558-80-7

Molecular formula:

H3O4P.Na

IUPAC Name:

sodium dihydrogen phosphate

Details on test material:

- Name of test material: Monocalcium phosphate, tricalcium phosphate, monopotassium phosphate, monosodium phosphate, sodium hexametaphosphate, tetrasodium pyrophosphate.

Dose method:

other: Injection into the egg yolk or air sac.

Analytical monitoring:

not specified

Vehicle:

yes

Test organisms

Test organisms (species):

other: Chicken

Study design

Limit test:

no

Remarks:

Single injection.

No. of animals per sex per dose and/or stage:

Not applicable, administration was to eggs. Approx. 100 eggs per test condition were used.

Control animals:

yes

Results and discussion

Repellency factors (if applicable):

No data

Any other information on results incl. tables

Monocalcium phosphate, tricalcium phosphate and monopotassium phosphate showed no teratogenic response. Only a few severe terata were seen after preincubation administration of monosodium phosphate in water by either yolk or air cell route. With administration at 96 h, however, numerous severe anomalies occurred at all dose levels for both routes. The anomalies included buphthalmia and cleft palate, celosomia, exencephaly, microcephaly, brachyganthia, hyperplasia of the heart, ablepharia, torticollis, microphthalmia, anophthalmia, coloboma, ectromalia and phocomelia.

Sodium hexametaphosphate showed essentially the same results in water as those indicated for monosodium phosphate. In addition to the severe structural anomalies, a large number of newly hatched birds were ataxic, with lack of control of the head and neck muscles.

Significant toxicity was produced by tetrasodium pyrophosphate in water under all conditions between 0.125 and 5 mg/egg. Serious terata were seen under three conditions of th etes; yolk treatment at 0 h resulted in only 1 bird with a serious anomaly (ectopia cardis). The other treatments resulted in many birds with severe and usually multiple terata. After air cell administration at 0 h, such abnormal birds occurred at all test levels at an incidence greated than solvent background, although the difference was not significant at the p = 0.05 level. Treatment at 96 h for both routes of administration resulted in significant increases (p≤ 0.05) at most of the test levels. The abnormalities observed were those described for the other phosphate compounds.

Applicant's summary and conclusion

Validity criteria fulfilled:

not specified

Conclusions:

Monocalcium phosphate, tricalcium phosphate and monopotassium phosphate showed no teratogenic response. Monosodium phosphate, sodium hexametaphosphate and tetrasodium pyrophosphate produced teratogenic effects in the developing chicken embryo.

Study is not considered to be of relevance for REACH registration and therefore results cannot be used in a meaningful way and should be disregarded.