Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
From 2002-01-03 to 2002-01-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N,4-trimethylpiperazine-1-ethylamine
EC Number:
203-183-7
EC Name:
N,N,4-trimethylpiperazine-1-ethylamine
Cas Number:
104-19-8
Molecular formula:
C9H21N3
IUPAC Name:
dimethyl[2-(4-methylpiperazin-1-yl)ethyl]amine
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 180601
- Expiration date of the lot/batch: 2002-10-25

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark


Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
no details provided

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
no details provided
Doses:
200 mg/kg ; 2000 mg/kg body weight
No. of animals per sex per dose:
2 groups:
2 females - 2000 mg/kg body weight
2 females - 200 mg/kg body weight

Control animals:
no
Details on study design:
Animals were subjected to daily observations and weekly determination of body weight.
All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Two females were found dead within 5.5 hours post-treatment (2000 mg/kg). No further mortality occured.
Clinical signs:
other: One decedent showed lethargy, hunched posture, uncoordinated movements, slow breathing, piloerection and ptosis. No clinical signs of toxicity were noted in the other decedent. Animals given 200 mg/kg showed lethargy on day 1.
Gross pathology:
Dark red discoloration of the glandular mucosa of the stomach and dark red discoloration of the forestomach was noted in one animals that died during the study, at macroscopic post mortem examination. The other decedent showed dark red discoloration of the forestomach and the jejunum and ileum contained hemorrhagic fluid. Macroscopic post mortem examination of the other animals did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The oral LD50 value for female rats was established to be within the range of 200-2000 mg/kg body weight.
Based on these rsults and according to the CLP Regulation, the test substance is considered classified as acute oral toxicant category 3.