Registration Dossier
Registration Dossier
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EC number: 278-817-9 | CAS number: 78014-16-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study planned
- Study period:
- The study will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006, and a deadline to submit the information required has been set by the Agency.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Triacetonetriamine
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : none concerning repeated dose toxicity
- Available non-GLP studies : none concerning repeated dose toxicity
- Historical human data : none concerning repeated dose toxicity
- (Q)SAR : none concerning repeated dose toxicity
- In vitro methods : no valid methods available concerning repeated dose toxicity
- Weight of evidence : no data available
- Grouping and read-across : no data on strucutral analogues available
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The substance is produced in quantities above 100 tonnes/year. There are no reliable data available on the sub-chronic toxicity (90-day) of the substance. In order to fullfil the standard information required, a GLP compliant sub-chronic toxicity study (90-day) via the oral route following OECD guideline 408 with a special focus on the reproductive system and sperm motility is proposed according to Annex IX, Column I, 8.6.2 of the REACH Regulation.
Data source
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- 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
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- yes
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
