Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no details about the test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other:
Deviations:
no
Principles of method if other than guideline:
Young adult laboratory mice were purchased from a breeder. Usually the source and strain of the animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously by ip injections with preparations of the test substance in a suitable vehicle.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Stearic acid chloride
IUPAC Name:
Stearic acid chloride
Details on test material:
- Name of test material (as cited in study report): Stearinsäurechlorid
- Physical state: liquid
- Analytical purity: 98 %
- pH: acidic
- melting point: 7,3

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 31-42 g (male), 24-35 g (female)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: water with adjuvant
Doses:
200, 250, 320, 400, 800, 1600 ml/kg
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:
clinical observation:10 min; 4h, 6h p.a. on day of administration, once daily the following days exept on weekend and holidays
weighing: only at the beginning of the study for dose calculation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 203 mg/kg bw
Remarks on result:
other: calculated using a density of 0.9 g/ml for stearic acid chloride
Mortality:
1600 ml/kg: 5/5 (male) 5/5 (female)
800 ml/kg: 5/5 (male) 5/5 (female)
400 ml/kg: 5/5 (male) 5/5 (female)
320 ml/kg: 5/5 (male) 5/5 (female)
250 ml/kg: 5/5 (male) 4/5 (female)
200 ml/kg: 1/5 (male) 0/5 (female)
death occured in a time period fom 24 h p.a. until 10 day p.a.
Clinical signs:
Tremor, twitching, convulsions accelerated discontinuous breathing, high steepy gait directly after injection.
closed eyes, discontinuous breathing, abdominal postition until day 9 after administration. Surviving animals without syptoms fom day 10 onward.
Body weight:
only determined at the beginning of the study for applying the right dose: 31-42 g (male), 24-35 g (female)
Gross pathology:
peritional adhesive desease

Applicant's summary and conclusion

Executive summary:

Several groups of 5 mice per sex and dose were treated simultaneously by ip injections with preparations of the test substance in a suitable vehicle. The LD50 after ip application is about 225 ml/kg in mice. based on the tensity of 0.9 g/ml this calculates to a LD 50 of 203 mg/kg.

Conclusion

The LD50 after ip application is about 225 ml/kg in mice. based on the tensity of 0.9 g/ml this calculates to a LD 50 of 203 mg/kg.