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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: assessment based on available information
Adequacy of study:
key study
Study period:
November 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP-assessment report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Objective of study:
other: toxicokinetic assessment
Principles of method if other than guideline:
Assessment of all available data
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene
EC Number:
615-240-7
Cas Number:
710292-85-6
Molecular formula:
Not available for this UVCB
IUPAC Name:
Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene
Constituent 2
Reference substance name:
HK 128
IUPAC Name:
HK 128
Constituent 3
Reference substance name:
203695
IUPAC Name:
203695
Test material form:
other: red-violet waxy solid
Details on test material:
- Name of test material (as cited in study report): HK 128
- Physical state: red-violet waxy solid
- Analytical purity: 94-95%
Radiolabelling:
no

Test animals

Species:
other: none
Strain:
other: none

Administration / exposure

Route of administration:
other: oral, dermal and inhalation
Vehicle:
unchanged (no vehicle)
Details on exposure:
see assessment

Results and discussion

Main ADME results
Type:
other: see conclusions

Any other information on results incl. tables

The test substance - a UVCB - has a low water solubility (0.035 mg/L), which is not favorable for absorption. The partition coefficient of 5.14 is also indicative of low absorption after oral intake. Based on these physico-chemical properties it is therefore unlikely that the substance will show a high systemic exposure after oral administration.


The test substance has been administered orally to rats for at least 4 weeks in an OECD 422. Systemic effects were observed at the mid and high dose levels, demonstrating a clear absorption of the substance upon oral administration. Based on this experimental data and as a worst case approach, the oral absorption is considered at 100% for risk assessment purposes.


In the gastro-intestinal tract, the test substance may be metabolized. Excretion will occur mainly via urine (low molecular weight products) or bile (high molecular weight products). Based on the partition coefficient, the test substance may accumulate to some extent in adipose tissue.


The test substance is a waxy solid, with a low vapour pressure (0.0001 Pa) and high boiling temperature (> 250°C, degradation). Based on these characteristics, the substance is not expected to enter the respiratory tract and subsequent absorption of the test substance via inhalation is considered negligible.


According to the criteria given in the REACH guidance, 10% dermal absorption will be considered in case MW > 500 and log Pow <(-1) or > 4, otherwise 100% dermal absorption should be used. As the criteria for 10% dermal absorption are not met, 100% dermal absorption should be considered for risk assessment purposes.

Applicant's summary and conclusion

Conclusions:
The test substance - a UVCB - has a low water solubility (0.035 mg/L), which is not favorable for absorption. The partition coefficient of 5.14 is also indicative of low absorption after oral intake. Based on these physico-chemical properties it is therefore unlikely that the substance will show a high systemic exposure after oral administration.

The test substance has been administered orally to rats for at least 4 weeks in an OECD 422. Systemic effects were observed at the mid and high dose levels, demonstrating a clear absorption of the substance upon oral administration. Based on this experimental data and as a worst case approach, the oral absorption is considered at 100% for risk assessment purposes.

In the gastro-intestinal tract, the test substance may be metabolized. Excretion will occur mainly via urine (low molecular weight products) or bile (high molecular weight products). Based on the partition coefficient, the test substance may accumulate to some extent in adipose tissue.

The test substance is a waxy solid, with a low vapour pressure (0.0001 Pa) and high boiling temperature (> 250°C, degradation). Based on these characteristics, the substance is not expected to enter the respiratory tract and subsequent absorption of the test substance via inhalation is considered negligible.

According to the criteria given in the REACH guidance, 10% dermal absorption will be considered in case MW > 500 and log Pow <(-1) or > 4, otherwise 100% dermal absorption should be used. As the criteria for 10% dermal absorption are not met, 100% dermal absorption should be considered for risk assessment purposes.
Executive summary:

Oral and dermal absorption are estimated at 100% while absorption via inhalation is negligible.