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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
unsuitable test system
Remarks:
The administration of the substance to the peritoneum (i.p. injection) does not represent a relevant route of exposure for humans.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
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

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
EC Number:
217-461-0
EC Name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
Cas Number:
1860-26-0
Molecular formula:
C24H51N
IUPAC Name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
Test material form:
liquid
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 or test system 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)
Remarks:
0.5% aqueous preparation
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

Conclusions:
One male animal of the high dose group died after 7 days of substance administration.
The surviving 19 animals (4 female, 5 male administered 8170 mg/kg bw and 5 female, 5 male administered 3791 mg/kg bw) were sacrificed at study day 14 and showed intraabdominal adhesions with fibrinous secretion of the serosa.
Therefore, no LD50 effect level could be determined and a discriminating dose of 8170 mg/kg bw is presented as effect level.