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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: not limit test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by GLP lab

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

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:
C24 H46 O10 P2 Ti2 (typical - see 'Remarks' below.
IUPAC Name:
butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: none
Details on oral exposure:
Method of administration: Oral Gavage
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosage 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):
8 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):
8 animals (low dose - 1 male, middle dose - 1, male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.

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

Any other information on results incl. tables

8 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 gain was lowered for males (weeks 1 and 2) and females (weeks 1 and 4) in the high dose group.

Applicant's summary and conclusion

Conclusions:
Not classified.