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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.