Perfluamine

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:

16 November 2012 - 20 November 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:

FC-3283 concentration in bioactive medium water for Daphina ecotoxicity study was analyzed 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-3283

IUPAC Name:

FC-3283

Details on test material:

- Name of test material (as cited in study report): FC-3283
- Substance type: Single-component substance
- Physical state: Clear and colorless liquid
- Analytical purity: 91.71%
- Expiration date of the lot/batch: 07/28/2016
- Storage condition of test material: room temperature

Results and discussion

Any other information on results incl. tables

For the four samples dosed with FC-3283 in which no daphnia was added and stored refrigerated, the measured FC-3283 concentrations ranged from 0.570 ng/mL to 20.8 ng/mL, with an average concentration of 5.96 ng/mL, the RSD was 170% (Table 1).

For the one sample (E11-0832-007) that was dosed with FC-3283 in which no daphnia was added and underwent ecotoxicity test condition, duplicate measured concentration of 1.65 ng/mL and 1.77 ng/mL were reported.

FC-3283 has measured water solubility range of 0.0695 -1.96 ng/mL, whereas the measured FC-3283 in bioactive medium is approximately 10 fold higher. For difficult substance such as this, a wide range of test results is considered acceptable.

Table 1. FC-3283 Test Substance, Abiotic (no Daphnia).
Sample ID	Sample Description	On-Column Amount (ng)		Sample FC-3283 Concentration (ng/mL)
E11-0832-007.1	FC-3283 test substance, abiotic, test conditions, sample		4.95	1.65
E11-0832-007.2	FC-3283test substance, abiotic, test conditions, sample duplicate		5.31	1.77
	Average (E11-0832-007)			1.71
	% RPD			7.0
E11-0832-008	FC-3283 test substance, abiotic, refrigerated		1.13	1.13
E11-0832-009	FC-3283 test substance, abiotic, refrigerated		62.5	20.8
E11-0832-010	FC-3283 test substance, abiotic, refrigerated		1.71	0.570
E11-0832-011	FC-3283 test substance, abiotic, refrigerated		3.95	1.32
	Average (E11-0832-008 through -011) (N=4)			5.96
	%RSD			170

Applicant's summary and conclusion

Conclusions:

The FC-3283 concentration in bioactive medium water ranged from 0.570 ng/mL to 20.8 ng/mL, with an average concentration of 5.96 ng/mL.

Executive summary:

Analytical testing of FC-3283 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-3283, in which no daphnia was added and the sample was stored refrigerated. The measured FC-3283 concentrations ranged from 0.570 ng/mL to 20.8 ng/mL, with an average concentration of 5.96 ng/mL and the RSD was 170%. One sample was dosed with FC-3283, in which no daphnia was added but the sample underwent ecotoxicity test condition. Duplicate measured concentration of 1.65 ng/mL and 1.77 ng/mL were reported.

This study was conducted under GLP. The analytical method meets generally accepted scientific principles. For difficult substance such as FC-3283, the concentration in the bioactive medium in the range reported (0.570 - 20.8 ng/mL) with an average of 5.96 ng/mL is considered acceptable with restriction. This study may aid in understanding test results for ecotoxicity.