Butanamine, N,N-dibutyl-, branched and linear, fluorinated

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Remarks:

other: Read across from in vivo data

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Data source

Reference

Reference Type:

other: Read across from other internal studies

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Read across from category members

Principles of method if other than guideline:

Trend analysis from category members show that members are practically nontoxic by oral exposure. Slope of trend line equals zero.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Category members

IUPAC Name:

Category members

Details on test material:

Perfluorohexanes, CAS# 1064697-81-9
Perfluoroheptanes, CAS# 1064698-16-3
Perfluorotributylamines, CAS# 1064698-37-8
Perfluorotripropylamines, CAS# 338-83-0
Perfluoro-N-methylmorpholine, CAS# 382-28-5
Perfluoro-N-C1,3-alkyl morpholines, CAS# 1093615-61-2
Perfluoro-C6,8-furans, pyrans and acyclic ethers , CAS# 1064698-52-7

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

At least 28 days

Frequency of treatment:

Once daily

Control animals:

yes

Examinations

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

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

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

no effects observed

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

CLINICAL SIGNS AND MORTALITY: No clinical signs reported at any dose in any study. No mortality occured during any study.
BODY WEIGHT AND WEIGHT GAIN: Weight gains were normal in all studies.

Effect levels

Dose descriptor:

NOAEL

Effect level:

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

Sex:

male/female

Basis for effect level:

other: Taking into account the MW of PTBA the calculated NOAEL is >1682 mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

PTBA is a member of the Perfluorinated Organic Chemicals, C5-C18, category. All of these chemicals stem from the same manufacturing process, have similar physicochemical properties including high vapor pressure and low water solubility relative to the hydrocarbon analogs (e.g., hexanes v. perfluorohexanes), and also lack any chemically reactive groups, which forms the technical basis for the category. Members of this category are fully fluorinated, meaning that fluorine, rather than hydrogen, is bonded to all carbon atoms in the molecule. Fluorine is the most electronegative of the elements (fluorine has an electronegativity of 3.98 on the Pauling scale, as compared to 2.55 for carbon or 2.20 for hydrogen). This electronegativity is expected to dominate over all other aspects of substance chemistry and is the underlying basis for similarity of substances in this category. Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Applicant's summary and conclusion

Conclusions:

The category has a No Observed Adverse Effect Level (NOAEL) of greater than 1000 mg/kg/day.

Executive summary:

A 28 day oral toxicity study was performed with male and female rats on category members. Rats were dosed with category members once daily by oral gavage. Clinical observations were recorded for all animals daily through the treatment period. Gross necropsy was performed on all animals following the treatment period. No mortality or histopathologic abnormalities were observed due to treatment in any study. Based on these results the category members have a No Observed Adverse Effect Level (NOAEL) of greater than 1000 mg/kg/day.

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members. The read across is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.