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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
basic toxicokinetics, other
Remarks:
Written assessment
Type of information:
other: Written assessment
Adequacy of study:
other information
Study period:
March 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Written assessment
Justification for type of information:
At the current level of registration, a written assessment is suitable.

Data source

Reference
Reference Type:
other: Written assessment
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Objective of study:
other: Written assessment of ADME
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Written assessment based on available study data.

Test material

1
Chemical structure
Reference substance name:
Heptanal, oligomeric reaction products with aniline
EC Number:
500-007-3
EC Name:
Heptanal, oligomeric reaction products with aniline
Cas Number:
9003-50-3
Molecular formula:
(C7H14O)n.(C6H7N)n
IUPAC Name:
Heptanal, oligomeric reaction products with aniline
Test material form:
liquid
Details on test material:
Test item: 207368/A
Identification: Hepteen Base®
Appearance: Clear amber liquid (determined by Charles River Den Bosch)
Batch: LT5C30Y170
Purity/Composition: 99.7%
Test item storage: At room temperature
Stable under storage conditions until: 30 November 2016 (retest date)

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
See attached background material below.
Details on distribution in tissues:
See attached background material below.
Details on excretion:
See attached background material below.

Metabolite characterisation studies

Details on metabolites:
See attached background material below.

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:
See attached background material below.

Applicant's summary and conclusion

Conclusions:
In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route, but for worst case risk assessment, 100% absorption is proposed. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential within man.
Executive summary:

In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route, but for worst case risk assessment, 100% absorption is proposed. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential within man.