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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1991-January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study described in this report was conducted in compliance with the Good Laboratory Practice (GLP) Regulations

Justification for type of information:

The study described in this report was conducted in compliance with the Good Laboratory Practice (GLP) Regulations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC Council Recommendation 87/176/EEC OJ no. L 73/2 (annexV, Part 2, Chapter 1, B.1)

Principles of method if other than guideline:

Methods: Other: EEC Council Recommendation 87/176/EEC OJ no. L 73/2 (annexV, Part 2, Chapter 1, B.1)

GLP compliance:

yes

Test type:

acute toxic class method

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 animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Vehicle:

water

Doses:

0; 200; 2000; 5000. (mg ABA/kg)

No. of animals per sex per dose:

5

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No clinical signs of toxicity were found

Executive summary:

The purpose of this study was to determine the acute toxicity of HN-70101 (ABA) in rats after a single dose of the compound by oral administration. 4 groups of males and females (5/sex/group) were dosed orally 0, 200, 2000, and 5000 mg/kg, control received the vehicle only. All animals were observed twice daily for mortality and clinical signs of toxicity. Body weights were recorded before treatments, at week 1 and 2 after compound administration; food consumption was recorded at week 1 and 2 after compound administration. Gross necropsies were performed on all animals. Clinical signs: No clinical signs of toxicity were found. Mortality: Approximate LD50: > 5000mg/kg in both sexes No animal died during the study. Body weight: No effects on body weight gain were seen. Food consumption: No remarkable differences in comparison to control were seen. Pathology: At necropsy no gross lesions were found