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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

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 203 (Fish, Acute Toxicity Test)

Version / remarks:

July 17, 1992

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:

20 mL of test samples from each group was drawn at 0 and 24 h of first renewal. The representative samples were divided into two equal portions (10 mL). One portion (10 mL) was sent for test concentration analysis and the second portion (10 mL) was stored at -20 ± 5 ºC temperature till the study completion.

Test solutions

Vehicle:

no

Details on test solutions:

An amount of 2012 mg FiberHance BM Solution was dissolved in RO water and made up to 10 L in fish tank to achieve a test concentration of 201.2 mg FiberHance BM Solution/L equivalent to a dissolved solid fraction concentration of 100 mg/L. The test solutions were thoroughly mixed to achieve uniform distribution of the test item within the aquaria. The test medium in the aquaria was changed every 24 h and replaced with the freshly prepared test item solution. At each renewal, 100% of volume of the tank was renewed. During renewal, fish was transferred by netting to new test vessels.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Test System: Healthy Rainbow Trout, Oncorhynchus mykiss were originally procured from the Indo- Norwegian Trout Farming Project Patlikuhal, Katrain, Distt. Kullu, Himachal Pradesh- 175129 and maintained at Section – Ecotoxicology, Jai Research Foundation were used for study.
Feeding: The fish were fed daily with Trout starter feed. Feed was withheld 24 h before the exposure to FiberHance BM Solution and throughout the exposure period.
Acclimatisation: A total of 20 healthy fish were received into the experimental room and allowed to acclimatise for 8 days prior to testing in a glass aquarium containing water identical to that to be used in the main study. The water was maintained between 16.2 and 16.8 °C temperature with 87.4 and 93.1% dissolved oxygen content as air saturation value, pH was maintained between 7.20 and 7.41 and total hardness of 100.8 mg/L as CaCO3 (TABLE 3). No signs of physical or behavioural abnormalities or mortalities of fish were observed during the acclimatisation period.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

89.6 to 100.8 mg/L as CaCO3

Test temperature:

16.0 to 16.6 °C

pH:

7.08 to 7.54

Dissolved oxygen:

70.1 to 92.1%

Nominal and measured concentrations:

Dissolved solid fraction: 100 mg/L, corresponding with 201 mg Fiberhance BM Solution/L

Details on test conditions:

Test Procedure: Semi-static toxicity test - Test solutions were changed every 24 h with freshly prepared solutions. The test solutions were not aerated during the exposure.
Loading: A maximum loading of 0.9 g of fish per liter of water was used. The volume of water used was 10 liters in a glass tank of 20 liters capacity for control and treated groups.
Test Concentrations: 0.0 (control) and 100 mg a.i./L
No of Fish per Group: 10 fish per group
Duration : 96 h exposure
Photoperiod : 16 h light and 8 h dark
Feeding : None during test period

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

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:

mortality (fish)

Remarks on result:

other: Measured concentration in agreement with nominal

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 fish as no mortality has occurred at a concentration of 100 mg/L. The LC50 is > 100 mg/L.