2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine

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-3284 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-3284

IUPAC Name:

FC-3284

Details on test material:

- Name of test material (as cited in study report): FC-3284
- Substance type: single-constituent substance
- Physical state: Clear and colorless liquid
- Analytical purity: 96.67%
- Storage condition of test material: room temperature

Results and discussion

Any other information on results incl. tables

For the four samples dosed with FC-3284 in which no daphnia was added and stored refrigerated, the measured FC-3284 concentrations ranged from 153 ng/mL to 637 ng/mL, with an average concentration of 295 ng/mL, the RSD was 78% (Table 1).

For the one sample (E11-0829-007) that was dosed with FC-3284 in which no daphnia was added and underwent ecotoxicity test condition, duplicate measured concentration of 438 ng/mL and 432 ng/mL were reported.

FC-3284 has measured water solubility range of 758 ng/mL, whereas the measured FC-3284 in bioactive medium ranged from 153 ng/mL to 637 ng/mL. For difficult substance such as this, a wide range of test results is considered acceptable.

Table 1. FC-3284 concentration inbioactive medium water -Test Substance, Abiotic (no Daphnia).
Sample ID	Sample Description	On-Column Amount (ng)		Sample FC-3284 Concentration (ng/mL)
E11-0829-007.1	FC-3284 test substance, abiotic, test conditions, sample		43.8	438
E11-0829-007.2	FC-3284test substance, abiotic, test conditions, sample duplicate		43.2	432
	Average (E11-0829-007)			435
	% RPD			1.3
E11-0829-008	FC-3284 test substance, abiotic, refrigerated		63.7	637
E11-0829-009	FC-3284 test substance, abiotic, refrigerated		15.3	153
E11-0829-010	FC-3284 test substance, abiotic, refrigerated		15.9	159
E11-0829-011	FC-3284 test substance, abiotic, refrigerated		23.0	230
	Average (E11-0829-008 through -011) (N=4)			295
	%RSD			78

Applicant's summary and conclusion

Conclusions:

The FC-3284 concentration in bioactive medium water ranged from 153 ng/mL to 637 ng/mL, with an average concentration of 295 ng/mL.

Executive summary:

Analytical testing of FC-3284 concentration in bioactive medium water for Daphnia ecotoxicity study was performed using purge and trap gas chromatography/mass spectrometry (GC/MS).

Four samples dosed with FC-3284 in which no daphnia was added and stored refrigerated, the measured FC-3284 concentrations ranged from 153 ng/mL to 637 ng/mL, with an average concentration of 295 ng/mL and the RSD was 78%. One sample dosed with FC-3284 in which no daphnia was added but underwent ecotoxicity test condition, duplicate measured concentration of 438 ng/mL and 432 ng/mL were reported.

This study was conducted under GLP. The analytical method meets generally accepted scientific principles. For difficult substance such as FC-3284, the concentration in the bioactive medium in the range reported (153 - 637 ng/mL) with an average of 295 ng/mL is considered acceptable with restriction. This study may aid in understanding test results for ecotoxicity.