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Toxicological information

Acute Toxicity: oral

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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: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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 application 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.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma WIGA, Sulzfeld
- Weight at study initiation: male animals; 188g, female animals; 159 g
- Fasting period before study: 16 hours
- Diet: MRH-Kraftfutter from the Firma H . EGGERSMANN (Rinteln/Weser), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4.64, 5.62, 6.81, 8.25, 10, 12.1 and 14.7 %

MAXIMUM DOSE VOLUME APPLIED: 1470 mg/kg
Doses:
464, 562, 681, 825, 1000, 1210 and 1470 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 24, 48 hours, 7 and 14 days
- 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. 700 mg/kg bw
Based on:
test mat.
95% CL:
640 - 770
Sex:
male
Dose descriptor:
LD50
Effect level:
670 mg/kg bw
Based on:
test mat.
95% CL:
580 - 750
Sex:
female
Dose descriptor:
LD50
Effect level:
740 mg/kg bw
Based on:
test mat.
95% CL:
650 - 860
Mortality:
464 mg/kg: 0/10 males and 1/10 females after 14 days
562 mg/kg: 5/10 males and 3/10 females after 14 days
681 mg/kg: 4/10 males and 4/10 females after 14 days
825 mg/kg: 8/10 males and 4/10 females after 14 days
1000 mg/kg: 9/10 males and 8/10 females after 14 days
1210 and 1470 mg/kg: all animals died after 14 days
Clinical signs:
Dyspnoea, apathy, agitation, aggressive, lateral and dorsal position, staggering, atony, paresis, trembling, spastic movement, rolling cramps, fever convulsions, diarrhea, salivation, diminished general state.
Gross pathology:
Acute dilation of the heart, acute congestion hyperemia, diffuse reddening of glands mucosa of proventriculus, atonic intestine, diarrhea in intestine, sporadic diffuse reddening of the mucosa of the intestine, brightening of the kidneys.

Euthanasied animals
Slight brightening of the kidneys with gridlike pattern.

Applicant's summary and conclusion

Executive summary:

In an oral toxicity study, comparable to OECD 401, dipropylenetriamine was administered to Sprague-Dawley rats (10animals/sex/dose) at 464 to 1470 mg/kg in single dosages (gavage) followed by a 14-day observation period.The LD50 was ca. 700 mg/kg bw.