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

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

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 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 13, 2004

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

Details on sampling:

10 mL of test samples from each replicates were drawn and mixed together to get a total volume of 40 mL for each group at every renewal. The samples were divided into two equal portions. One portion (20 mL) was sent for test concentration analysis and the second portion (20 mL) was stored at -20 ± 5 ºC temperature till the study completion.

Test solutions

Vehicle:

no

Details on test solutions:

10 mL of test samples from each replicates were drawn and mixed together to get a total volume of 40 mL for each group at every renewal. The samples were divided into two equal portions. One portion (20 mL) was sent for test concentration analysis and the second portion (20 mL) was stored at -20 ± 5 ºC temperature till the study completion.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Source: Healthy Daphnia magna (showing no signs of stress such as ephippia, delay in the production of the first brood, discolouration, etc. and having normal behavior) less than 24 h old (first instar nymph) cultured and bred in the Laboratory of Ecotoxicology, Jai Research Foundation, were used for the study. The master culture of Daphnia magna was originally procured from the MicroBio Test Inc, Kleimoer 15, 9030 Mariakerke (Gent), Belgium. The test system was validated for its sensitivity by conducting a validation study (Kamle, M.K., 2016: JRF Study N° 502-3-07-15505) with potassium dichromate as a positive control.
Acclimatisation: The test system (daphnids) were collected in a glass bottle containing 1000 mL of reconstituted water at the mean temperature of 20.1 ± 0.1 °C, mean dissolved oxygen level of 8.48 ± 0.02 mg/L as air saturation value, mean pH of 7.40 ± 0.01 measured daily and kept under a 16 h light and 8 h dark photoperiod during acclimatisation. The total hardness measured was 190.4 mg/L as CaCO3 and light intensity measured was 1320 lux, on the day of acclimatisation.
Selection: First instar daphnids (less than 24 h old, neonates) were separated from the adults in a culture of daphnia derived from a single mother. This culture had previously been acclimatised to the study conditions and was immediately transferred to labeled glass beakers (five for each replicate). Transfer was performed using a micropipette having a capacity of 100 – 1000 μL. The mobility of the test organisms was verified immediately after their introduction by gentle swirling of the test container.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

207.2 mg/L as CaCO3

Test temperature:

20.1 and 21.2 °C

pH:

between 7.48 and 7.97

Dissolved oxygen:

8.26 - 8.45 mg/L

Nominal and measured concentrations:

Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide: 0 and 100 mg/L

Details on test conditions:

Test Procedure: Static toxicity testing procedure (test medium was not changed during the study).
Loading : Each replicate comprising of five daphnids in 100 mL of test media
Container : Glass beaker of 600 mL capacity
Group Size : 20 daphnids per group. Each group consisted of four replicates of 5 daphnids per replicate
Duration : 48 h exposure period
Photoperiod : 16 h light and 8 h dark cycle
Feeding : None during exposure

Reference substance (positive control):

yes

Remarks:

using potassium dichromate as a positive control

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 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:

mobility

Remarks on result:

other: Measured concentration was in agreement with nominal

Results with reference substance (positive control):

Study Period: October 17, 2016 to October 24, 2016.
The 24 and 48 h EC50 of potassium dichromate were determined 1.63 and 0.67 mg/L, respectively.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide is not toxic to invertebrates as no immobility of Daphnia magna exposed has occurred at a concentration of 100 mg/L. The EC50 is > 100 mg/L.