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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
90 day
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only limited details provided in NONS summary

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Version / remarks:
Annex V
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
-
EC Number:
410-660-5
EC Name:
-
Cas Number:
1072830-14-8
Molecular formula:
Not Applicable for UVCB substance
IUPAC Name:
1-[bis(2-hydroxypropyl)amino]propan-2-ol 2-(rutherfordiooxy)ethan-1-ol 2-hydroxypropanoic acid amine titanium
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Distilled water
Details on oral exposure:
Method of administration:
Oral gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Details on results:
Clinical observations:
No deaths and no signs of toxicity were observed.
Only limited details provided in NONS summary
Laboratory findings:
No treatment-related changes in haematological parameters
were observed.

Slight (1-3%) increases in plasma sodium and chloride were
observed in males at all doses as were slight (20-30%)
decreases in triglycerides. These changes were not observed

in males which received 1000 mg/kg/day and were allowed to
recover for 2 weeks.

Effects in organs:
No treatment-related gross or microscopic findings were
observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Dosing Sprague-Dawley rats with dose levels of up to 1000 mg/day produced only equivocal haematology and clinical
chemistry effects in either sex not considered to be related to the test material.
Therefore is was concluded that the test material is not classified under the test conditions
Executive summary:

No adverse effects noted up to 1000 mg/kg/day