Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, OECD guideline n° 401 (1987 February 24th)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine
EC Number:
234-148-4
EC Name:
N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine
Cas Number:
10563-29-8
Molecular formula:
C8H21N3
IUPAC Name:
{3-[(3-aminopropyl)amino]propyl}dimethylamine
Details on test material:
- Name of test material (as cited in study report): Dimethyldipropylenetriamine
- Physical state: Liquid
- Analytical purity: 99.49%
- Purity test date: 1991-01-22
- Lot/batch No.: P 90.11
- Expiration date: no data
- Storage condition of test material: stored at room temperature, kept away from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ICO: OFA-SD (IOPS Caw) supplied by Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: approximalety 6 weeks
- Weight at study initiation: males: 184+/-5g, females 152+/-7g
- Fasting period before study: 18 hours before administration
- Housing: 5 animals of the same sex per cage during study
- Diet (e.g. ad libitum): ad libitum pellet diet "Rats-Mice sustenance ref. A04 C" (U.A.R. 91360 Villemoisson-sur-Orge)
- Water (e.g. ad libitum): ad libitum tap water filtered by a 0,22µ filter membrane (Société Millipore, 78140 Vélizy, France)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To: 1991-04-23

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: volume taking into consideration that the specific gravity (SG) of the test substance was 0.88.
Doses:
1000, 2000, 3000 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 and weighing: clinical signs checked once daily, animals weighted on day 5, 8 and 15
- Necropsy of survivors performed: yes, necropsy on all animals.
- Other examinations performed: Macroscopic examination on digestive track, heart, kidneys, libver, lungs, pancreas, spleen and any other organ with obvious anormalities. No histological examination was performed.
Statistics:
LD50 calculated according to a Probit analysis, Finney's method published by E. Weber and Bliss' method.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 669 mg/kg bw
95% CL:
1 249 - 2 086
Sex:
female
Dose descriptor:
LD50
Effect level:
1 545 mg/kg bw
95% CL:
690 - 2 379
Sex:
male
Dose descriptor:
LD50
Effect level:
1 907 mg/kg bw
95% CL:
467 - 2 273
Remarks on result:
other: 90% CL (not 95 %)
Mortality:
1000mg/kg: 10% (1 female found dead on day 7)
2000mg/kg: 60%
3000mg/kg: 100%
Clinical signs:
other: 1000mg/kg: hypokinesia bewteen 15 minutes and 6 hours 2000mg/kg: sedation, hypokinesia, dyspnea between 15 minutes and 6 hours, accompanied by tremors in 2 animals after 4 hours and coma for 1 animal after 6 hours. Hypokinesia persited therafter in a few
Gross pathology:
1000mg/kg: no apparent abnormalities observed
2000mg/kg: 1 female found dead on day 1, dark reddinsh stomach and intestines
2000mg/kg: 1 males found dead on day 1, dark stomach and black spleen
3000mg/kg: 2 males and 3 females on day 1, dark reddish stomach and intestineswith black liver and spleen.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of DIMETHYLDIPROPYLENETRIAMINE administered by oral route in rats was
- males, 1907 (467 - 2273) mg/kg with 90% confidence interval limits,
- females, 1545 (690 - 2379) mg/kg with 95% confidence interval limits,
- combined, 1669 (1249 - 2086) mg/kg with 95% confidence interval limits.
Executive summary:

The acute oral toxicity of Dimethyldipropylenetriamine was evaluated in rats according to OECD N°401 guideline. The test item was administered by oral route (gavage at 1000, 2000 and 3000 mg/kg) to groups of 10 Sprague-Dawley rats (5 males and 5 females). Animals were observed for 14 days.

100% mortality was observed for the high dose group on day 1 ; after administration animals showed sedation, lateral recumbency, piloerection and coma. These clinical signs were less severe in 2000 mg/kg group, althought 60% mortality was observed on day 5. The low dose group showed hypokinesia after treatment but only 10% mortality was observed. Under these experimental conditions, the oral LD50 of the test item is 1669 (1249 - 2086) mg/kg with 95% confidence interval limits.