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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Titanium salts are considered to be of low toxicity by ingestion.

Citric acid / citrates are metabolic products in cells and conisdered to be of low toxicity.

Further animal testing cannot be justified.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
90 days
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
The substance will readily dissociate under biological conditions and it is valid to consier the ions separately for long-term toxicity.
Titanium salts are considered to be of low toxicity by ingestion.
Citric acid / citrates are metabolic products in cells and conisdered to be of low toxicity.
Further animal testing cannot be justified.
equivalent or similar to guideline
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
GLP compliance:
Limit test:
Specific details on test material used for the study:
Not specifed.
Described as 'nano', but appears to be grade for paints.
Crj: CD(SD)
Route of administration:
oral: gavage
CMC (carboxymethyl cellulose)
Details on oral exposure:
Dosed with the vehicle at a volume of 10 mL/kg of body weight.
Analytical verification of doses or concentrations:
Details on analytical verification of doses or concentrations:
Samples taken at different times during the study. Ti measured by ICP methods
Duration of treatment / exposure:
Daily dosing over 90 days
Frequency of treatment:
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
300 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Control animals:
yes, concurrent vehicle
Details on study design:
Note that recovery from analysis indicated slightly reduced dosing from nominal.
Observations and examinations performed and frequency:
Twice daily observations.
Body weight checked weekly
Sacrifice and pathology:
Gross pathology and histology performed
Clinical signs:
no effects observed
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
no effects observed
Other effects:
no effects observed
Dose descriptor:
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: No effects
Remarks on result:
not determinable due to absence of adverse toxic effects
Critical effects observed:
No adverse effects when treated by gavage over 90 days at up to 1000 mg/kg/day nominal
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification