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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethyl-N'-(2,2,6,6-tetramethylpiperidin-4-yl)propane-1,3-diamine
EC Number:
278-817-9
EC Name:
N,N-dimethyl-N'-(2,2,6,6-tetramethylpiperidin-4-yl)propane-1,3-diamine
Cas Number:
78014-16-1
Molecular formula:
C14H31N3
IUPAC Name:
N-[3-(dimethylamino)propyl]-2,2,6,6-tetramethylpiperidin-4-amine
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-12 weeks (at study initiation)
- Weight at study initiation: 145-160 g
- Fasting period before study: overnight and approximately 3-4 hours after dosing
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
For the purpose of the study the test item was freshly prepared, as required, as a solution at the appropriate concentration in distilled water.
Doses:
2000 and 300 mg/kg b.w.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 0.5, 1, 2 and 4 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 500 mg/kg bw
Based on:
test mat.
Mortality:
Animals treated at a dose level of 2000 mg/kg bw were found dead six hours or one day after dosing. There were no deaths at a dose level of 300 mg/kg bw.
Clinical signs:
other: Signs of systemic toxicity noted at both dose levels were hunched posture, ataxia and ptosis. Noisy respiration and/or lethargy were also noted in animals treated at a dose level of 2000 mg/kg. Surviving animals appeared normal one hour to one day after d
Gross pathology:
Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver, gaseous stomach, haemorrhage,
epithelial sloughing and raised limiting ridge of the gastric mucosa, epithelial sloughing and reddened non-glandular region of the stomach,
gaseous small intestine, solid food matter and/or green, clear red or reddish/brown coloured liquid present in the stomach and dark green
substance present in the large intestine. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 of the test item in the female Wistar strain rat was approximately 500 mg/kg bw.
Executive summary:

A group of three fasted female Wistar rats was treated with the test item at a dose level of 2000 mg/kg bw. Based on the results from this dose level further groups of fasted females were treated at a dose level of 300 mg/kg bw.

Animals treated at a dose level of 2000 mg/kg bw were found dead six hours or one day after dosing. There were no deaths at a dose level of 300 mg/kg bw.

Signs of systemic toxicity noted were hunched posture, ataxia and ptosis. Noisy respiration and/or lethargy were also noted in animals treated at a dose level of 2000 mg/kg bw. Surviving animals appeared normal one hour to one day after dosing. The surviving animals showed expected gains in bodyweight over the study period.

Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver, gaseous stomach, haemorrhage, epithelial sloughing and reddened non-glandular region of the stomach, gaseous small intestine, solid food matter and/or liquid present in the stomach and dark green substance present in the large intestine. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg bw.