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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
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 and a slightly curved body position until Day 5. All animals recovered within 7 days.
Body weight:
No effect on body weight was noted.
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.

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