N,N'-bis[2-hydroxy-3-(2,2,3,3-tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2-diaminium dichloride

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Remarks:

other: Range finder study

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Dose range finding study for rat 28 day study (OECD 407). Performed according to the principles of GLP (OECD) using the same facilities and study procedures that were subject to routine inspection under the laboratory QA Programme. However, the study plan, experimental phases and final study report were not subject to Quality Assurance audit. Brief summary report providing only limited study details.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Principles of method if other than guideline:

no guideline required

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride

IUPAC Name:

N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride

Constituent 2

Reference substance name:

1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride

EC Number:

700-737-4

Cas Number:

1220100-43-5

Molecular formula:

C18H34F8N2O4.2Cl

IUPAC Name:

1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride

Details on test material:

Substance received as a clear colourless liquid (substance in solution)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Duration of treatment / exposure:

7 days

Frequency of treatment:

once daily

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
330 mg/Kg/day
Basis:
nominal in water

Doses / concentrations 2

Remarks:

Doses / Concentrations:
660 mg/Kg/day
Basis:
nominal in water

Doses / concentrations 3

Remarks:

Doses / Concentrations:
1320 mg/Kg/day
Basis:
nominal in water

No. of animals per sex per dose:

Groups 1-4. Each group consisted of 5 animals/sex.

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

All animals were observed twice daily for mortality and moribundity. Clinical examinations were performed daily and detailed physical examinations were performed on study days 0 and 7. Individual body weights and food consumption were recorded on study days 0 and 7. Gross necropsies were conducted on all animals; gross lesions were collected for possible future microscopic examination.

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

Body weights were unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Description (incidence and severity):

Food consumption was unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.

Details on results:

SURVIVAL

All animals survived to the scheduled necropsy.

CLINICAL OBSERVATIONS

There were no test article related clinical observations.

BODY WEIGHTS

Body weights were unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.

FOOD CONSUMPTION

Food consumption was unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.

ANATOMIC PATHOLOGY - MACROSCOPIC EXAMINATION

There were no test article related macroscopic findings at the scheduled necropsy. All macroscopic findings noted were considered to be spontaneous and/or incidental in nature and unrelated to test article administration.

Effect levels

Dose descriptor:

other: mortality

Effect level:

> 1 320 mg/kg bw/day (nominal)

Based on:

test mat.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on the results of this study, oral administration of the test substance to Crl:CD[SD] rats for 7 consecutive days at dosage levels of 330, 660, and 1320 mg/kg/day was well tolerated at all dosage levels. There were no treatment-related effects at 1320 mg/kg/day, the highest dosage level evaluated.

Executive summary:

The objective of the study was to investigate the potential toxicity of the test substance when administered daily by oral gavage to Sprague Dawley rats for 7 consecutive days.

Based on the results of this study, oral administration of the test substance to Crl:CD[SD] rats for 7 consecutive days at dosage levels of 330, 660, and 1320 mg/kg/day was well tolerated at all dosage levels. There were no treatment-related effects at 1320 mg/kg/day, the highest dosage level evaluated.