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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction: other studies
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:
2013

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Needle-shaped (nHA-ND) and rod-shaped (nHA-RD) hydroxyapatite (HA) nanoparticles were disolved in water and tagged by Fourrier Transform Infrared (FTIR) and fluorescent spectra. Then varying doses of hydroxyapatite nanoparticles were applicated to a culture of Catfish (Ictalarus punctatus, siluriformes) cells (B cells and T cells) for 24h. Viability was measured by PI staining and the cellular metabolic activity by MTS assay.
Also Zebrafish (Danio rerio, cypriniformes) were exposed to the nanoparticles. Toxicity was reported by death, deformation and hatching rates.
GLP compliance:
not specified
Type of method:
other: both in vitro and in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydroxylapatite (Ca5(OH)(PO4)3)
EC Number:
215-145-7
EC Name:
Hydroxylapatite (Ca5(OH)(PO4)3)
Cas Number:
1306-06-5
Molecular formula:
Ca5HO13P3
IUPAC Name:
pentacalcium hydroxide triphosphate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
nanoparticles of hydroxyapatite, needle- (NHA-ND) and rod-shaped (nHA-RD), synthesized and controlled by Transmission Electron Microscopy.
fluorescein isothiocyanate (FITC) was tagged to the particles for cellular uptake studies

Test animals

Species:
other: fish: in vitro: Ictalurus punctatus (B- and T-cells), in vivo: Dania rerio (embryos)
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: surrounding water
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
up to 24 h
Frequency of treatment:
once
Doses / concentrations
Remarks:
in vitro: 10 - 300 µg/ml, in vivo: 3 - 300µg/ml
No. of animals per sex per dose:
not reported
Control animals:
yes

Results and discussion

Observed effects

in vitro:Needle-shaped hydroxyapatite nanoparticles inhibit metabolic activity of catfish B cells and T cells. The time-dependent interaction with the test substance revealed that the cytotoxicity of nHA-ND may be caused by slow exocytosis.
in vivo: Both n-HA-forms delayed zebrafish embryo hatching. Approx. 75% of the embryos had malformed spines when exposed to nHA-ND at 120hpf.
The consistent sub-lethal toxic effects observed from the in vitro and in vivo models showed a general correlation between the two studies.

Applicant's summary and conclusion

Conclusions:
Nanoparticles of the trest substance have sub-lethal toxic effects on fish cells and fish embryos.