Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
11 Dec - 23 Dec 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Lack on test material details.

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
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
IUPAC Name:
N-methyl-N-oleoylglycine
Test material form:
other: solid, not further specified
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: EN 41700.92

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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified