(thiodi-4,1-phenylene)-bis-(diphenylbis)(OC-6,11)hexafluoroantimonate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Compliance

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate

EC Number:

403-500-0

EC Name:

A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate

IUPAC Name:

403-500-0

Constituent 2

Reference substance name:

reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate

IUPAC Name:

reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Method of administration: gavage

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Test Duration: 28 days

Frequency of treatment:

Dosing regime : 7 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
0,300, 600, 1000 mg/kg bw/day
Basis:
no data

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 300 mg/kg bw/day
Male: 5 animals at 600 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 300 mg/kg bw/day
Female: 5 animals at 600 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Control animals:

not specified

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

All effects were found in males only. At 300 mg/kg: no effects. At 600 mg/kg/day: slight hair loss was noted in 3 males. At 1000 mg/kg/day decreased body weight at day 21 ad 27 and slight hair loss in 3/5 males.

Mortality:

mortality observed, treatment-related

Description (incidence):

All effects were found in males only. At 300 mg/kg: no effects. At 600 mg/kg/day: slight hair loss was noted in 3 males. At 1000 mg/kg/day decreased body weight at day 21 ad 27 and slight hair loss in 3/5 males.

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

At 1000 mg/kg/day decreased body weight at day 21 ad 27

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Clinical biochemistry findings:

effects observed, treatment-related

Description (incidence and severity):

At 600 mg/kg/day: high alkaline and phosphate blood levels in males.

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

effects observed, treatment-related

Description (incidence and severity):

at 1000 mg/kg/day: swollen intestine in 3 males

Histopathological findings: non-neoplastic:

not specified

Details on results:

All effects were found in males only.
At 300 mg/kg: no effects. At 600 mg/kg/day: slight hair loss was noted in 3 males. At 1000 mg/kg/day decreased body weight at day 21 ad 27 and slight hair loss in 3/5 males.

Laboratory findings:
At 300 mg/kg/day: no effect noted.

At 600 mg/kg/day: decreased body weight in males, high alkaline and phosphate levels in males.

At 1000 mg/kg/day: iden as 600 mg/kg/day plus swollen intestine in 3 males

Effects in organs:
No evidence of abnormal histopathological findings.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: original NCD unit is mg/kg/day

2

Dose descriptor:

NOEL

Effect level:

300

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:

Classified as: Not Classified

Executive summary:

Limited data provided by ECHA. Not possible to make further conclusions.