C12-18-(even numbered, C18 unsaturated)-alkylamines acetates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C12-18-(even numbered, C18 unsaturated)-alkylamines acetates

EC Number:

946-260-7

Molecular formula:

R-NH2xHOOCCH3 R = alkyl mainly C12-18-(even numbered, C18 unsaturated)-alkyl

IUPAC Name:

C12-18-(even numbered, C18 unsaturated)-alkylamines acetates

Test material form:

other: solid

Details on test material:

- Physical state: waxy solid (colorless to slightly yellow)
- Stability of test item dilution: Stable under storage conditions.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
males: mean = 205 g, SD = 7, xmin = 197, xmax = 213, n=5
females: mean = 198 g, SD = 5, xmin = 192, xmax = 204, n=5

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage):

MAXIMUM DOSE VOLUME APPLIED:
25 ml (20% solution) = 2000 mg/kg bw

Doses:

1

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: squatting posture, decreased spontaneous activity, coat bristling, irregular respiration

Gross pathology:

Gross pathology of rats at the end of the observation period revealed in two cases that the stomach and pankreas was adhered to the connective tissue, in other cases no remarkable macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The median lethal dose of the substance (LD50) was > 2000 mg per kg body weight. Based on the result of this study the substance is not subject for labelling and classification requirements according to regulatory requirements

Executive summary:

The acute oral toxicity of the substance was investigated in rats using suspensions in deionized water oil at a concentration of 20%. 5 male and 5 female SPF-Wistar rats each were administered the substance by single-dose gavage at dose level of 2000 mg/kg body weight and were observed for 14 days after administration. After application the animals showed the following unspecific clinical symptoms: squatting posture, decreased spontaneous activity, coat bristling, irregular respiration. Gross pathology of rats at the end of the observation period revealed in two cases that the stomach and pankreas was adhered to the connective tissue, in other cases no remarkable macroscopic findings were observerd. The median lethal dose (LD50) was calculated to be > 2000 mg/kg body weight.