1,3-Benzenedicarboxamide, 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-, hydrochloride (1:1)

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:

April-July 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study meets the requirements of the OECD Principles of Good Laboratory Practice, Environment Monograph No. 45, OECD, Paris, 1992.

Justification for type of information:

This study meets the requirements of the OECD Principles of Good Laboratory Practice, Environment Monograph No. 45, OECD, Paris, 1992.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

421-690-3

EC Name:

-

Cas Number:

203515-86-0

Molecular formula:

C14H21N3O6 . ClH

IUPAC Name:

5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride

Constituent 2

Reference substance name:

3,5-bis[(2,3-dihydroxypropyl)carbamoyl]aniliniumchloride

IUPAC Name:

3,5-bis[(2,3-dihydroxypropyl)carbamoyl]aniliniumchloride

Details on test material:

- Name of test material (as cited in study report): ABA-HCl
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: Powder
- Analytical purity: ≥98.5
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: S-31308
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 6

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Any other information on results incl. tables

Sublethal observations / clinical signs:

Mortality . Negative control group: all animals survived until the end of the test.Test substance group:all animals survived until the end of the test. The LC50/96h was higher than 100 mg "ABA-HCl" per litre test medium. Animal Observation. All animals of the test substance group and the negative control group were inconspicuous in behaviour and appearance until the end of the test. Length of animals. Individual as well as mean body lengths of both groups were in the range specified by the guideline, i.e. 3.0 ± 0.5cm). Actual test substance concentrations. Mean actual concentrations of the test substance at various sampling times were between 94.9 and 101.1 % of the actual starting concentration in the test medium. The concentrations were therefore in acceptable range according to the guideline. Test media quality. Temperature: between 20.5oC and 21.0 oC throughout the test period. pH: between 7.1 and 7.7 throughout the test period. no marked influences by the test substance. no marked differences between the groups. Dissolved oxygen concentration: greater than 94% of the air saturation value at the appropriate temperature throughout the test period. no marked differences between the groups.

Applicant's summary and conclusion

Conclusions:

The conditions for the validity of the test were fulfilled:
1. Constant condition were maintained (temperature, pH).
2.No mortality occured in the negative control group.
3.The dissolved oxygen concentration was at least 60 % of the air saturation value throughout the test.
4. The concentration of the test substance has been satisfactorily maintained over the test period 8greater than 80 % of the actual starting concentration in the test medium).
In this static test in Zebrafish (Brachydanio rerio) over the test period of 96 hours the LC50/96 was greater than 100 mg "ABA-HCl" per litre test medium.

Executive summary:

There was no mortality in the test substance group or in the negative control group. The concentration of the test substance was sufficiently stable over the test period (approximately 97% of the actual starting concentration at the end of the exposure, the maximum deviation was 5% at 48 hrs after the start of the study). pH and temperature were stable throughout the test period. Dissolved oxygen concentration was always greater than 94% of the air saturation value at the appropriate temperature. The LC50/24hr, 48hr, 72hr, 96hr of “ABA-HCl” was therefore greater than 100 mg/l test medium. The LC 100/96hr was greater than 100 mg/l test medium. The no observed effect concentration was higher than 100 mg/l test medium.