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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Type of information:
other: Assessment of toxicokinetic behaviour
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: expert statement

Data source

Materials and methods

Objective of study:
absorption
excretion
metabolism
other: bioaccumulation
GLP compliance:
no

Results and discussion

Applicant's summary and conclusion

Executive summary:

1. Absorption

Oral

The physico-chemical properties of the notified substance
are such that after ingestion, the chemical is expecetd to
dissociate inti its constituents both under the acid
conditions of the stomach, and the alakline conditions of
the duodenum. The increase in liver weight in the 28 day
oral study indicates that the notified substance or one of
its metabolites is absorbed from the GI tract.

Dermal

The physico-chemical properties of the notified substance
indicate that dermal absorption may occur.

Inhalation

The particle size distribution of the notified substance
indicated that only less than 0.5% is respirable. Most of
the inhaled particles will be deposited in the
nasopharyngeal region before being cleared by mucociliary
transport to the oral cavity adn swallowed. Absorption would
then be the same as for oral uptake.


2. Metabolism

There are several routes possible for the metabolism of the
notified substance. Metabolites could be formed by oxidation
both at the methyl group aqnd along the aliphatic side
chains linked to the aromatic ring. The aliphatic side chain
is expected to be partially biodegradable by alpha- and
beta-oxidation.


3. Excretion

The major pathway of excretion of the aromatic derivatives
is expected to be as glucuronic acid-conjugates via the
bile. It is possible, but rather unlikely, that better
water-soluble metabolites could beformed by extensive
oxidation of the sidechain and by sulfatation. These
metabolites coulöd be excretable also via the urine.


4. Bioaccumulation

The low values for the log P for both components indicate
that anaccumulation of the adduct or a component in the
fatty tissue is rather unlikely.