1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C16-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide

EC Number:

246-584-2

EC Name:

(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide

Cas Number:

25054-76-6

Molecular formula:

C25H48N2O3

IUPAC Name:

N-(carboxymethyl)-N,N-dimethyl-3-(oleoylamino)propan-1-aminium hydroxide

2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

3

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

propylene glycol

4

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Initial testing with 5 females and 5 females will be performed at a dose of 5000 mg/kg. If mortality does not exceed 50% at this dose level, no further dose levels will be tested, If mortality os produced, additional dose levels will be performed in order to obtain the LD50 value. All animals will be dosed by oral gavage with the rest material

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

All animals will be individaully housed in stainless stell cages and offered food and water ad libitum. All test animals will be fasted overnight prior to dosing. Following dosing, all test animals will be oserved daily for 14 days following dosing for any toxic or deleterious effects, The weight of each animal will be determined prior to dising, at death, or at the end of the 14 day observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities observed during the study

Clinical signs:

other: There were no clinical signs of toxicity observed during the study

Gross pathology:

No gross changes observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The Acute oral LD50 was found to be > 2000 mg/kg

Executive summary:

Based on the results of this study, the LD50 of the test material is considered to be greater than 2000 mg/kg and does not meet the GHS classification criteria for acute toxicity.