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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

3-aminopropan-1-ol is one of the constituents of Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide.at a molar ratio of 1:1. The process used is a pseudo acid – base reaction in water that leads always to a mixture of the “amide” and the “salt” part. Both entities are required for the applications performances. With the manufacturing process used here it is not possible to separate the amide and salt part from the water phase. The 3-aminopropan-1-ol is the kation of the salt part.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropan-1-ol

EC Number:

205-864-4

EC Name:

3-aminopropan-1-ol

Cas Number:

156-87-6

Molecular formula:

C3H9NO

IUPAC Name:

3-aminopropan-1-ol

Details on test material:

- Name of test material (as cited in study report): 3-Aminopropanol; Substance ID 78/701
- no further details given

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 220-260 g, female: 160-180 g
- Fasting period before study: 15-20 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4.64, 6.85, 10, 14.7, 21,5 %

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

464, 681, 1000, 1470, 2150 mg/kg

No. of animals per sex per dose:

5 male and 5 female animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: before study, after 2-4 days, 7 days and 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 348 mg/kg bw

Mortality:

1 of 10 animals died at 464 mg/kg
1 of 10 animals died at 681 mg/kg
no animals died at 1000 mg/kg
5 of 10 animals died at 1470 mg/kg
all animals died at 2150 mg/kg

Clinical signs:

clinical signs included: apathy, dyspnoea, stertorous respiration, gasping, apathy, staggering, urine of strong yellow colour, scrubby fur, anaemic paleness, blood in nose and saliva, bad general condition. Most of these clinical signs were only observed in the two highest dose groups.

Gross pathology:

The sacrificed animals were without findings.
The following findings were made in animals that died during the study:
heart: acute right dilation
liver: circumferential delineation of the liver lobes
stomach: atonic, reddened mucosa
intestine: reddened mucosa
lung: slight emphysema

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

As one mol of Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide contains 0.5 mol of 3-aminopropan-1-ol, and gluconic acid is not classified, its oral LC50 is > 2000 mg/kg bw.