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

Additional information on environmental fate and behaviour

Administrative data

Endpoint:

additional information on environmental fate and behaviour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 November 2012 - 04 December 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted under GLP. The analytical method meets generally accepted scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Sample concentrations of FC-43 in bioactive medium water for Daphina ecotoxicity study were measured using Purge and Trap Gas Chromatography/Mass Spectrometry. Analytical testing was performed under 40 CFR 792.113(a)(1) requirements for REACH registration.

GLP compliance:

yes

Type of study / information:

Behavior in biological media.

Test material

Test material information

Constituent 1

Reference substance name:

FC-43

IUPAC Name:

FC-43

Details on test material:

- Name of test material (as cited in study report): FC-43
- Physical state: Clear and colorless liquid
- Analytical purity: 98.85%
- Expiration date of the lot/batch: 07/19/2016
- Storage condition of test material: room temperature

Results and discussion

Any other information on results incl. tables

For the four samples dosed with FC-43 in which no daphnia were added and stored refrigerated, the measured FC-43 concentrations ranged from 0.217 ng/mL to 1.81 ng/mL, with an average concentration of 0.710 ng/mL, the RSD was 100% (Table 1).

For the one sample dosed with FC-43 in which no daphnia were added (abiotic study vials) and underwent ecotoxicity test condition, duplicate measured concentration of 0.110 ng/mL and <0.103 ng/ml were reported.

FC-43 has measured water solubility of < 0.0561 ug/L at approximately 23˚C, whereas the measured FC-43 in bioactive medium is substantially higher. For difficult substance such as this, a wide range of test results is considered acceptable.

Table 1. Results Summary: FC-43 Test Substance, Abiotic (no daphnia).
Sample ID	Sample Description	On-Column Amount (ng)	Sample FC-43 Concentration (ng/mL)
E11-0831-007.1	FC-43 test substance, abiotic, test conditions, sample	0.551	0.110
E11-0831-007.2	FC-43 test substance, abiotic, test conditions, sample duplicate	< 0.515	< 0.103
	Average (E11-0831-007)		0.110
	% RPD		NA
E11-0831-008	FC-43 test substance, abiotic, refrigerated	2.20	0.439
E11-0831-009	FC-43 test substance, abiotic, refrigerated	1.08	0.217
E11-0831-010	FC-43 test substance, abiotic, refrigerated	9.05	1.81
E11-0831-011	FC-43 test substance, abiotic, refrigerated	1.87	0.374
	Average (E11-0831-008 through -011) (N=4)		0.710
	%RSD		100

Applicant's summary and conclusion

Conclusions:

The FC-43 concentration in Bio-active medium water ranged form 0.217 ng/mL to 1.81 ng/mL, with an average concentration of 0.710 ng/mL.

Executive summary:

Analytical testing of FC-43 concentration in bioactive medium water for Daphnia ecotoxicity study was performed using purge and trap gas chromatography/mass spectrometry (GC/MS).

Four samples were dosed with FC-43 in which no daphnia was added and stored refrigerated, the measured FC-43 concentrations ranged from 0.217 ng/mL to 1.81 ng/mL, with an average concentration of 0.710 ng/mL, the RSD was 100%. One sample dosed with FC-43 in which no daphnia was added (abiotic study vials) and underwent ecotoxicity test condition, duplicate measured concentration of 0.110 ng/mL and < 0.103 ng/ml were reported.

This study was conducted under GLP. The analytical method meets generally accepted scientific principles. For difficult substance such as FC-43, the concentration in the bioactive medium in the range reported (0.217 - 1.81 ng/mL) with an average of 0.710 ng/mL is considered acceptable with restriction. This study may aid in understanding test results for ecotoxicity.