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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study summary available only from OECD SIDS Document.

Data source

Reference
Reference Type:
other: OECD SIDS
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes
Limit test:
yes

Test material

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: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% methylcellulose (MC) solution
Analytical verification of doses or concentrations:
not specified
Doses / concentrations
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not examined

Details on results (P0)

During the observation period, there were no dose related effects on clinical signs, body weights, food consumption, mating, gestation, delivery, organ weights, necropsy and histopathology in parents.

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Remarks:
systemic
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: highest dose tested

Target system / organ toxicity (P0)

Key result
Critical effects observed:
no

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No dose-related changes in clinical signs, body weights, viability index, external malformations and sex ratios were noted in pups.

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: highest dose tested

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:
No reproductive or developmental toxicity was reported after oral administration to rats.
Executive summary:

Titanium dioxide has been investigated in a reproductive and developmental toxicity screening test in rats (OECD TG 421). Titanium dioxide was administered by oral gavage to 10 animals/sex at 0 or 1000 mg/kg bw/day (limit test), to male rats from two weeks prior to mating, during the mating period and, approximately, two weeks post mating, and to female rats from two weeks prior to mating, during the mating period, gestation period and 3 days after lactation. During the observation period, there were no dose related effects on clinical signs, body weights, food consumption, mating, gestation, delivery, organ weights, necropsy and histopathology in parents. No dose-related changes in clinical signs, body weights, viability index, external malformations and sex ratios were noted in pups. This study found no indication of any reproductive toxicity in parent animals or developmental toxicity in pups. Therefore, the NOAEL for reproductive and developmental toxicity was 1000 mg/kg bw/day.