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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Validated in vitro basal cytotoxicity bioassay intended to estimate rodent oral LD50; GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The basal cytotoxicity of the test substance was evaluated in vitro, using a Neutral Red Uptake Assay in Balb/c 3T3 Mouse Fibroblasts. This is a survival/viability chemosensitivity assay based on the ability of viable cells to incorporate and bind neutral red (NR), a supravital dye. NR is a weak cationic dye that readily penetrates cell membranes by non-ionic diffusion and accumulates in lysosomes. Alterations of the cell surface or the sensitive lysosomal membrane result in a decreased uptake and binding of NR. Correlations between cytototoxicity and rodent median lethal dosages (LD50) have been established from existing databases for a wide range of chemicals.

GLP compliance:

yes

Remarks:

FDA, EPA, OECD

Test type:

other: Basal Cytotoxicity in NRU 3T3 Mouse Fibroblasts

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:

- Physical state: Solid, white
- Storage condition of test material: Room temperature, protected from light, in a dessicator

Test animals

Species:

other: Not applicable

Strain:

other: Not applicable

Administration / exposure

Doses:

Based on the results of a dose range-finding assay, eight concentrations of the test substance ranging from 100,000 µg/mL to 401 µg/mL were chosen for two definitive assays. Sodium Lauryl Sulfate (SLS) was used as a positive control.

Results and discussion

Any other information on results incl. tables

The mean NRU₅₀value obtained from two studies with the test substance was 13,700ug/ml, while that of the SLS positive control was 37.1. The SLS result and other study parameters met established criteria for a valid test. The NRU₅₀value obtained for the test substance is considered indicative of a very low order of acute oral toxicity.

Applicant's summary and conclusion

Interpretation of results:

other: Very low order of acute oral toxicity

Conclusions:

Based upon the in vitro basal cytotoxicity test using Neutral Red Uptake in Balb/c 3T3 mouse fibroblasts, the test substance was considered to have a very low order of acute oral toxicity, with an estimated rodent oral LD50 of 8840 mg/kg.

Executive summary:

The basal cytotoxicity of the substance was evaluated in vitro, using a Neutral Red Uptake Assay in Balb/c 3T3 Mouse Fibroblasts. This is a survival/viability chemosensitivity assay based on the ability of viable cells to incorporate and bind neutral red (NR), a supravital dye. NR is a weak cationic dye that readily penetrates cell membranes by non-ionic diffusion and accumulates in lysosomes. Alterations of the cell surface or the sensitive lysosomal membrane result in a decreased uptake and binding of NR. Correlations between cytototoxicity and rodent median lethal dosages (LD50’s) have been established from existing databases for a wide range of chemicals.

Based on the results of a dose range-finding assay, eight concentrations of the substance ranging from 100,000 µg/mL to 401 µg/mL were chosen for two definitive assays. Sodium Lauryl Sulfate (SLS) was used as a positive control. 

The mean NRU₅₀value obtained from two studies with the test substance was 13,700ug/ml, while that of the SLS positive control was 37.1.The SLS result and other study parameters met established criteria for a valid test. The NRU₅₀value obtained for the substance is considered indicative of a very low order of acute oral toxicity, with an estimated rodent oral LD50 of 8840 mg/kg.