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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Principles of method if other than guideline:
BASF-Test: The test substance was administered into the peritoneal cavity of male and female mice to detect the acute toxicity.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
EC Number:
607-896-8
Details on test material:
- Name of test material (as cited in study report): Tridecanol (mixture of branched aliphatic alcohols)
- Physical state: liquid

Test animals

Species:
mouse
Strain:
other: Tuebinger
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean: 29 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: aqueous emulsion with traganth
Details on exposure:
VEHICLE
- Concentration in vehicle: 20, 8 or 2 %
Doses:
1.6 ml/kg bw, 0.8 ml/kg bw, 0.4 ml/kg bw, 0.2 ml/kg bw (= 1349 mg/kg bw, 674 mg/kg bw, 337 mg/kg bw, 169 mg/kg bw; calculated by means of the density: 843 g/l at 20°C)
No. of animals per sex per dose:
5 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (1.6 ml/kg bw, 0.8 mg/kg bw and 0.4 mg/kg bw), 7 days (0.2 ml/kg bw)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The original citation was LD50 = ca. 0.6 ml/kg bw; calculation in mg/kg bw by means of the density: 843 g/l at 20°C
Mortality:
- after 14 days:
1.6 ml/kg bw: 5/5 (died between 48 h and 14 days after administration);
0.8 ml/kg bw: 4/5 (died between 7days and 14 days after administration);
0.4 ml/kg bw: 1/5 (died within 48 h after administration);
0.2 ml/kg bw: 0/5 (observation finished 7 days after administration);
Clinical signs:
- on the day of administration: quiet behaviour, high stepping gait, staggering, accelerated respiration, convulsion (from time to time);
- 1 day after administration till 6 days after administration: gaunt flanks, accelerated and intermittent respiration, piloerection, abdominal position (sporadic)
In part, the survivors were not without findings until day 7 after administration.
Body weight:
no data
Gross pathology:
3 killed animals: slight agglutination of the organs in the peritoneal cavity
other animals: organs without findings

Applicant's summary and conclusion