D-Gluconic acid, δ-lactone, reaction products with propanolamine

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Version / remarks:

March 23, 2006

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

D-Gluconamide, N-(3-hydroxypropyl)-

Cas Number:

190445-18-2

Molecular formula:

C9H19NO7

IUPAC Name:

D-Gluconamide, N-(3-hydroxypropyl)-

Constituent 2

Reference substance name:

gluconic acid, aminopropanol salt

Molecular formula:

C9 H21 N1 O8

IUPAC Name:

gluconic acid, aminopropanol salt

Test material form:

liquid

Remarks:

50% solution in water

Details on test material:

% solids in water: 48.0 - 52.0

Specific details on test material used for the study:

Test Item Name FiberHance BM Solution
Batch/Lot Number SMSN-071916
CAS Name D-Gluconic acid, δ-lactone, reaction products with propanolamine
CAS Number (CAS RN) 2060570-71-8
Analysed Purity 49.71% w/w (Refer Certificate of Analysis in APPENDIX 5)
Supplied to JRF by Ashland Services B.V.
Date of Manufacture July 19, 2016
Date of Expiry July 19, 2017
Appearance Colourless, Odorless clear liquid
Storage Condition
(at JRF) As per the instruction received from the Sponsor on storage of the test item, the test item was stored :
Storage Temperature : 20 -25 °C
Storage Container : In original container as supplied by the Sponsor
Storage Location : Test Item Control Office, JRF

Sampling and analysis

Analytical monitoring:

yes

Test organisms

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

Name of the Organism : Pseudokirchneriella subcapitata
Strain Number : ATCC 22662
Origin and Source : American Type Culture Collection, 10801, University of Boulevard, Manassas, Virginia, 20110-2209, USA
Subculture Maintained at : Section - Ecotoxicology, Jai Research Foundation, Valvada, Dist. Valsad, Gujarat
Date of Receipt (at JRF) : May 13, 2010
Date of Last Subculture : April 28, 2017
Method of Cultivation : Static condition

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Test conditions

Test temperature:

21 - 23 °C

pH:

7.35 – 7.76

Nominal and measured concentrations:

Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide: 0.0 (control), 9.5, 17.1, 30.9, 55.6 and 100.0 mg/L

Details on test conditions:

Mean Illumination (lux) : 6387 - 6420 (± 15% of the mean value) (APPENDIX 2)
Culturing Apparatus : 250 mL sterile conical flask
Initial Mean Number of (Cells/mL): 9000

Reference substance (positive control):

yes

Remarks:

JRF Study N° 501-3-07-15504 (Study Period: October 20, 2016 to October 25, 2016)] using potassium dichromate as the positive control

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

13.56 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

32.7 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide

Basis for effect:

growth rate

Effect concentrations 3

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

4.72 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide

Basis for effect:

growth rate

Details on results:

The time weighed average concentrations ranged from 100 to 111% relative to nominal during the 72-hour period.

Results with reference substance (positive control):

EC50 = 3.46 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of the statistical analysis, the NOEC and LOEC values for biomass (cell growth), growth rate and yield ware 9.5 and 17.1 mg FiberHance BM Solution/L corresponding with dissolved solid fractions of 4.72 and 8.50 mg/L, respectively.