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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2021

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

Constituent 1
Reference substance name:
A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
EC Number:
403-490-8
EC Name:
A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
IUPAC Name:
403-490-8
Constituent 2
Reference substance name:
reaction mass of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate, diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate, propylene carbonate
IUPAC Name:
reaction mass of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate, diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate, propylene carbonate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: none
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 / concentrationsopen allclose all
Dose / conc.:
300 mg/kg bw/day (actual dose received)
Dose / conc.:
600 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
1000 mg/kg/day lower body weight oin day 27 and at the end of the study in males only. Lower dosage no signs of toxicity
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
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
neutrophils were increased in top dose males
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
decreases in alkaline phosphatase and AST were seen in top dose males and mid and top dose females respectively. All were normal after 2 weeks recovery
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
1000 mg/kg/day: relative increase of liver weight in males.
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
600 mg/kg bw/day (nominal)
Basis for effect level:
gross pathology

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.