Titanium dioxide

Endocrine disrupter mammalian screening – in vivo (level 3)

Administrative data

Endpoint:

endocrine disrupter mammalian screening – in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

other: Not rated acc. Klimisch et al.

Rationale for reliability incl. deficiencies:

other:

Remarks:

The references contained in this summary entry represent non-guideline investigations with very limited value for risk assessment purposes. All references do not fulfil the criteria for quality, reliability and adequacy of experimental data for the fulfilment of data requirements under REACH and hazard assessment purposes (ECHA guidance R4 in conjunction with regulation (EC) 1907/2006, Annexes VII-X). The information contained therein were included for information purposes only

Data source

Reference

Reference Type:

publication

Title:

The use of ex vivo ovary culture for assessment of alterations in steroidogenesis following neonatal exposure to poly(ethylene glycol)-block-polylactide methyl ether or titanium dioxide nanoparticles in Wistar rats

Author:

Scsukova, S., Mlynarcikova, A.B., Rollerova, E.

Year:

2020

Bibliographic source:

Endocrine Regul. 54, 1, 53-63

Materials and methods

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Titanium dioxide

EC Number:

236-675-5

EC Name:

Titanium dioxide

Cas Number:

13463-67-7

Molecular formula:

O2Ti

IUPAC Name:

dioxotitanium

Test material form:

solid: nanoform

Test animals

Species:

other: Scsukova, S. et al. (2020): female rats (Wistar)

Sex:

female

Administration / exposure

Route of administration:

other: Scsukova, S. et al. (2020): intraperitoneal injection

Results and discussion

Effect levels

Remarks on result:

other:

Remarks:

Scsukova, S. et al. (2020): Terminal body and ovary weights were not statistically significantly altered after neonatal TiO2 NP exposure. After ex vivo culture of rat ovaries collected on PND15, basal progesterone and estradiol levels measured in the culture media did not differ between control and both TiO2 NP-treated groups. The ovaries from rats neonatally exposed to both doses of TiO2 NPs failed to respond to FSH/IGF stimulation in progesterone secretion at all time intervals.

Applicant's summary and conclusion

Conclusions:

No conclusion can be drawn from the above publications due to lack of quality, reliability and adequacy of the experimental data for the fulfilment of data requirements under REACH.
The references contained in this summary entry represent non-guideline investigations with very limited value for risk assessment purposes. All references do not fulfil the criteria for quality, reliability and adequacy of experimental data for the fulfilment of data requirements under REACH and hazard assessment purposes (ECHA guidance R4 in conjunction with regulation (EC) 1907/2006, Annexes VII-X). The information contained therein were included for information purposes only.

Scsukova, S. et al. (2020): The study design is not compliant with any existing validated test guideline. The non-physiological administration via intraperitoneal injection is considered to be a non-relevant exposure route. The test material is insufficiently characterised. Only two dose levels were tested which hampers a robust analysis of potential dose-response relationships. The description of the test animals lacks details. Cytotoxicity was not evaluated. The stimulation of ex vivo ovaries is an artificial test system.