Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
basic toxicokinetics
Type of information:
other: Literature based toxicokinetic assessment
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available

Data source

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
EC Number:
421-660-1
EC Name:
Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
Molecular formula:
Hill formula: C50 H96 N2 O10 CAS formula: C42 H74 O8. 2(C4 H11 N O)
IUPAC Name:
bis((2-hydroxyethyl)dimethylazanium) (4E)-3-{[2-({3-carboxylato-3-[(2E)-hexadec-2-en-2-yl]propanoyl}oxy)ethoxy]carbonyl}-4-methyloctadec-4-enoate
Constituent 2
Reference substance name:
BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)
IUPAC Name:
BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Elimination of the absorbed notified substance or its metabolites is likely to occur via the urine
Oral absorption of the notified substance is indicated by pathological changes in the liver and kidneys observed in a 28 day repeat dose study.  Dermal uptake is likely to be limited due to the high molecular weight of the notified substance, although some evidence of dermal absorption is provided by the weak positive skin sensitisation reaction. The high water solubility suggests that any absorbed substance would be distributed throughout the body water. No useful information is available from the studies available concerning metabolism.  Due to its high water solubility, elimination of the absorbed notified substance or its metabolites is likely to occur via the urine.
Executive summary:

Oral absorption of the notified substance is indicated by pathological changes in the liver and kidneys observed in a 28 day repeat dose study.  Dermal uptake is likely to be limited due to the high molecular weight of the notified substance, although some evidence of dermal absorption is provided by the weak positive skin sensitisation reaction.
The high water solubility suggests that any absorbed substance would be distributed throughout the body water. No useful information is available from the studies available concerning metabolism.  Due to its high water solubility, elimination of the absorbed notified substance or its metabolites is likely to occur via the urine.