Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to OECD guideline study. Acceptable, well documented report which meets basic scientific principles. Study was conducted before establishment of the OECD Test Guideline, but study protocol is in principle similar to OECD TG 401, with acceptable restrictions (limited documentation).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
Observation period only 7 days instead of 14 days as outlined in OECD TG 401.
Principles of method if other than guideline:
BASF-test.
Groups of Sprague-Dawley rats were treated by single gavage 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 7 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
Test type:
standard acute method
Limit test:
yes

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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 230 g (mean), female: 182 g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
emulsion in 0.5% aqueous CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35%
Doses:
10000 µL/kg bw equivalent to approx. 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: 7 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:
No mortality occured.
Clinical signs:
No symptoms observed
Body weight:
See details in remarks on results.
Gross pathology:
No abnormalities observed.

Any other information on results incl. tables

Body Weight (g):

Dose (mg/kg bw) Gender  day 0  day 4  day 7          
8170 male   210  241  288          
8170 female  168  173  184          

Applicant's summary and conclusion