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: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
BASF-test
Groups of NMRI mice were treated by single intraperitoneal administration with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tri-2-Aethylhexylamin
- Physical state: liquid
- Analytical purity: approx. 98%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 27.6 g (mean), female: 22.2 g (mean)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
VEHICLE
- Concentration in vehicle: 35%
Doses:
4640 and 10000 µL/kg bw equivalent to approx. 3791 and 8170 mg/kg bw (conversion in mg/kg bw is based on the density of 0.817 g/cm3).
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: daily
- Frequency of weighing: days 0, 4, 7
- 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:
> 8 170 mg/kg bw
Based on:
test mat.
Mortality:
At 3791 mg/kg bw: no mortality occurred.
At 8170 mg/kg bw: 0/5 females died; 1/5 males died (time of death: D7)
Clinical signs:
Slight apathy, dyspnoea, bad general state.
Body weight:
Body weight gain was within normal limits during study period.
Gross pathology:
Deceased animal:
The mouse that died on day 7 after substance administration, did not show any abnormalities at necropsy.
Sacrificed animals:
The animals sacrificed at study termination showed intraabdominal adhesions with fibrinous secretion of the serosa. Water-clear ascites.

Applicant's summary and conclusion