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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
EC Number:
401-100-0
EC Name:
Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
Cas Number:
109037-78-7
Molecular formula:
not applicable
IUPAC Name:
dititanium(4+) triethanolate bis(propan-1-olate) dibutyl phosphate butyl phosphate

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
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 160 mg/kg bw/day
Male: 5 animals at 400 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 160 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Eight animals (low dose - 1 male, middle dose - 1 male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
Mortality:
mortality observed, treatment-related
Description (incidence):
Eight animals (low dose - 1 male, middle dose - 1 male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Body weight gain was lowered for males (wees 1 and 2) and females (weeks 1 - 4) in the high dose group.
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
Effects in organs:
No treatment related effects were seen at necropsy or on
histological examination.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
400 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
0 mg/kg bw/day (nominal)
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:
Substance is not classified