Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
EC Number:
282-199-6
EC Name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
Cas Number:
84144-79-6
Molecular formula:
C14H26N3O2
IUPAC Name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
Test material form:
liquid: viscous
Details on test material:
Manufacturer Air Products and Chemicals
Batch # 8418406
Radiolabelling:
no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Supporting information from a single dose administration investigation and from the rodent twenty eight
day repeated dose oral (gavage) toxicity study suggest that the gastro-intestinal tract would be the
primary route of absorption following oral administration before entering the circulatory system via the
blood. Some absorption may also take place through the skin barrier with damage to the skin surface
enabling increased penetration. The physico-chemical characteristics imply the risk of vapor inhalation
to be minimal and the low water solubility and high log octanol/ water coefficient would imply that
absorption from the gut may be limited.
Details on distribution in tissues:
Systemic distribution in the twenty eight day repeated dose oral (gavage) toxicity study in the rat can be
inferred from the treatment-related histological changes identified in the mesenteric lymph nodes and may
be further supported from provided information from a single dose administration study. As a positive
response was elicited by the test item in a skin sensitization it can be assumed systemic distribution may
be further facilitated by the test item binding to carrier proteins in the circulatory systems.
Details on excretion:
There is no evidence to indicate the route of excretion but poor water-soluble products are not favourable
for urinary excretion and therefore biliary excretion may be a significant route for this material. Any test
item that is not absorbed likely to be excreted in the faeces.

Metabolite characterisation studies

Metabolites identified:
no

Any other information on results incl. tables

Metabolism

Results from the rodent twenty eight day repeated dose oral (gavage) toxicity study did not provide

evidence to indicate any test item influenced hepatic metabolism. The results of the genotoxicity assays

all proved negative with finding neither enhanced nor diminished in the presence of the S9 metabolising

Applicant's summary and conclusion

Conclusions:
The information provided supports the view that absorption of the test substance would take place via the
gastrointestinal tract but that the physico-chemical characteristics including low water solubility and high
log octanol/ water coefficient may limit absorption from the gut and for similar reasons the risk of vapor
inhalation is considered to be minimal. Some absorption may also take place via the skin. Once
absorbed, the substance would be distributed via serum in the circulatory system. Any absorbed material
is likely to undergo hepatic transformation and clearance is therefore expected to be via the bile with
subsequent excretion in the faeces. None of information provided indicated any evidence to suggest that
the test substance may be metabolised, however no studies have been conducted to identify the presence
of metabolites.
Executive summary:

The information provided supports the view that absorption of the test substance would take place via the

gastrointestinal tract but that the physico-chemical characteristics including low water solubility and high

log octanol/ water coefficient may limit absorption from the gut and for similar reasons the risk of vapor

inhalation is considered to be minimal. Some absorption may also take place via the skin. Once

absorbed, the substance would be distributed via serum in the circulatory system. Any absorbed material

is likely to undergo hepatic transformation and clearance is therefore expected to be via the bile with

subsequent excretion in the faeces. None of information provided indicated any evidence to suggest that

the test substance may be metabolised, however no studies have been conducted to identify the presence

of metabolites.