Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Dec - 23 Dec 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of test material details

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

EC Number:

203-749-3

EC Name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

Cas Number:

110-25-8

Molecular formula:

C21H39NO3

IUPAC Name:

N-methyl-N-oleoylglycine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 154 ± 6.8 g (males), 163 ± 10.5 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Diet: rat food (NAFAG, Gossau SG), ad libitum
- Housing: animals were housed in groups of 5 in Macrolon III cages
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% carboxymethylcellulose + 0.1% Tween 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Animals showed slight signs of dyspnoea from 1 h to 6 days after treatment. Animals had slight exophthalmos until 5 h after administration. Animals showed slight to moderate ruffled fur until Day 4. Slight to moderate diarrhoea was observed until Day 2 a

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.