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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
1999-09-20 - 1999-11-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (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-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine
EC Number:
229-761-9
EC Name:
N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine
Cas Number:
6711-48-4
Molecular formula:
C10H25N3
IUPAC Name:
(3-{[3-(dimethylamino)propyl]amino}propyl)dimethylamine
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): JCZR50B (JEFFCAT ZR-50B)
- Substance type: Colorless liquid
- Physical state: Liquid
- Lot/batch No.: 160-0497
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Age at study initiation: Males: 8 weeks, females: 10 weeks
- Weight at study initiation: 180 - 194 grams (dose range); 179 - 287 grams (assay)
- Fasting period before study: animals were fasted over the night before dose administration.
- Housing: Rats were group-housed prior to treatment initiation. During the study, animals were housed individually in stainless steel cages in compliance with USDA guidelines.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days prior to treatment initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Test article formulation:
The test article was prepared on a weight to volume basis with distilled water
Doses:
500 mg/kg, 1000 mg/kg, 1250 mg/kg, 1600 mg/kg
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 and weighing:
Clinical observations:
Recorded 1 and 4 hours (± 15 minutes) after dosing and once daily through Day 15. Signs of toxicity were recorded at least once daily as they were observed, including time of onset, degree and duration.
Weighing: Body weight: Recorded on day 1 (fasted) and on days 8 and 15 (at terminal sacrifice)
- Necropsy of survivors performed: yes: all rats were sacrificed on day 15 by CO2 asphyxiation and gross necropsies were performed, which included examination of the external body surfaces, all orifices and the thoracic, abdominal and pelvic cavities and their contents.
Statistics:
Evaluations were made of clinical signs and body weight data. Body weights were summarized using descriptive statistics (mean and standard deviation).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 250 - < 1 600 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 500 and 1000 mg/kg. Three of ten and ten of ten were found dead at 1250 and 1600 mg/kg, respectively.
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
All surviving animals gained weight over the course of the study.
Gross pathology:
No visible lesions were observed at 500 and 1000 mg/kg or in the surviving animals at 1250 mg/kg. At 1250 mg/kg necropsy observations included stomach-distended and/or fluid-filled red; abdominal cavity - fluid-filled; intestines -fluid-filled (red) and distended; and liver - mottled and/or soft. At 1600 mg/kg necropsy observations included stomach - fluid-filled red; distended, red lesions; and intestines fluid-filled red.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based upon the results of this study, the estimated LD50 for the test article, was between 1250 and 1600 mg/kg.