Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles (non-GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Principles of method if other than guideline:
BASF-TEST: Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium sarcosinate
EC Number:
224-338-5
EC Name:
Sodium sarcosinate
Cas Number:
4316-73-8
Molecular formula:
C3H6NNaO2
IUPAC Name:
sodium (methylamino)acetate

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSAGE PREPARATION
- Stock solutions prepared: 2% for the 200 mg/kg dose group, 20% for the 1600 mg/kg dose group, 30% for the 3200 and 6400 dose group
- Dose volume applied: 10 ml/kg bw for the 200 mg/kg bw dose group; 8 ml/kg bw for the 1600 mg/kg bw dose group; 10.66 ml/kg bw for the 3200 mg/kg bw dose group; 21.4 ml/kg bw for the 6400 mg/kg bw dose group.
Doses:
200; 1600; 3200; 6400 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
At the highest dose (6400 mg/kg bw) one male died three days after application.
Clinical signs:
other: 3200, 6400 mg/kg bw: directly after application irregular respiration, convulsions; reversible within 2 days 200, 1600 mg/kg bw: piloerection; reversible within one day
Gross pathology:
Animal which died: intestinal paralysis, dilatation of the stomach which was filled with yellow aqueous substance
Animals sacrificed:
3200, 6400 mg/kg bw: bronchitis in 6 animals
1600 mg/kg bw: slight dilatation of the stomach in two animals
200 mg/kg bw: nothing abnormal detected

Applicant's summary and conclusion