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Environmental fate & pathways

Additional information on environmental fate and behaviour

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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

Reference
Name:
Unnamed
Type:
Constituent
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.