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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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:

no guideline followed

Principles of method if other than guideline:

Inhalation hazard test, animals exposed for 1 hour

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-Aminopropan-1-ol; Substance-ID: 78/701
- Physical state: yellowish clear liquid
- Analytical purity: 99.5-99.7 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: MUS RATTUS, Brunnthal
- Weight at study initiation: 185 +/- 15 g
- Diet: Herilan MRH, ad libitum
- Water: Tap water, ad libitum

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: head-nose inhalation system
- Method of holding animals in test chamber: animals are held in a tube, the head/nose being exposed to the inhalation chamber

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gas chromatography

Duration of exposure:

1 h

Concentrations:

0, 6.64, and 16.35 mg/l analytical concentration

No. of animals per sex per dose:

10 male and 10 female animals per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, 7 and 14
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Data were anlysed according to the "Bionominaltest" (Wittig H, Mathematische Statisik, 1974, pp 32-35)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 16.4 mg/L air (analytical)

Exp. duration:

1 h

Mortality:

no death occurred

Clinical signs:

other: aqueous, reddish eye and nose secretion, irregular respiration, scrubby and clotted fur, hairless necrotic areas with bloody eschar. The animals were not free of symptoms at the end of the observation period (14 days).

Body weight:

male and female animals of the 16.35 mg/l dose group showed no differences compared to the control group. Male animals of the 6.64 mg/l dose group showed no differences compared to the control group. The female animals of the 6.64 mg/l dose group showed a slight weight loss after 7 days and decreased body weight gain after 14 days compared to controls.

Gross pathology:

nothing abnormal detected

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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 4h-LC50 for inhalation of mists (aerosols) is > 5 mg/L (expected at > 8 mg/).