Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05. Jun 1967 - 14. Jun 1967
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:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
(7 day observation period; highest dose tested was 1612 mg, but all animals of this dose group - besides one male animal - died)
Principles of method if other than guideline:
BASF-Test. The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage 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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): di-(2-aethylhexyl)-amine
- Analytical purity: > 99%
no further data

Test animals

Species:
rat
Strain:
other: US-rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 254 g (mean), female: 206 g (mean).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous Traganth solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2% (161 mg/kg bw), 20% (806, 1008, 1290, 1612 mg/kg bw)

MAXIMUM DOSE VOLUME APPLIED: 6.25 ml (1250 mg/kg bw), 5 ml (1000 mg/kg bw), 8 ml (1600 mg/kg bw), 10 ml (200 / 2000 mg/kg bw)

Doses:
161, 806, 1008, 1290, 1612 mg/kg bw (= 200, 1000, 1250, 1600, 2000 mL/kg bw ; calculation of doses in mg/kg bw by means of density = 0.8062 g/mL)
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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 008 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Systemic toxicity (including mortality) and local irritation observed; see descritpions below for details
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 149 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 847 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Females appeared to be more sensitive.
Mortality:
1612 mg/kg bw: 1 male died within 24 h. 3 males and 5 females died within 48 h. 4 males died within 7 days. 1 male animal survived.
1290 mg/kg bw: 1 male and 3 females died within 24 h. 2 males and 4 females died within 48 h. 5 males and 5 females died within 7 days.
1008 mg/kg bw: 2 females died within 24 h. 5 females died within 48 h. All males survived.
806 mg/kg bw: 1 female died within 7 days. All other animals survived.
161 mg/kg bw: No animal died.
Clinical signs:
1612 – 806 mg/kg bw: Irregular / accelerated respiration, heavy ruffled fur, anogenital region smeared with feces (diarrhea), squatting posture, apathy, red eye and nose crusts. The survivors recovered.
161 mg/kg bw: Same but less distinct symptoms as in higher dose groups. 24 h post treatment the animals were considered as normal.
Body weight:
no data
Gross pathology:
dead animals (806 - 1612 mg/kg bw): Dilated stomach in 18 cases, atony in 8 cases, and blood smeared snouts.

sacrificed animals: Uneven faded liver, adhesion between liver, stomach, spleen and left kidney; bronchitis, bronchopneumonia with emphysema.

Any other information on results incl. tables

Mortality

 Dose (mg/kg bw) Gender  1 h  24 h  48 h  7 days  
1612 male  0/5  1/5 3/5  4/5    
  female  0/5  0/5  5/5  5/5    
1290 male  0/5  1/5  2/5  5/5  
  female  0/5  3/5  4/5  5/5  
1008 male  0/5 0/5  0/5 0/5  
  female  0/5 2/5  5/5  5/5   
806 male  0/5  0/5  0/5  0/5    
  female   0/5  0/5  0/5  1/5  
161 male   0/5  0/5  0/5  0/5    
  female  0/5  0/5  0/5  0/5    

The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependent manner.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The study on acute oral toxicity of Di-2-ethylhexylamin in male and female US-rats resulted in a LD50 value for both sexes of 1008 mg/kg bw. The female animals appeared to be more sensitive. A classification according to the CLP Regulation (EC) No. 1272/2008 (EU-GHS: Cat. 4) is required.