Registration Dossier

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Weight of evidence
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Weight of evidence
Title:
Toxicokinetics
Author:
Sustainability Support Services (Europe) AB
Year:
2014
Bibliographic source:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Radiolabelling:
not specified

Test animals

Species:
other: unspecified
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: estimation
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
no data
No. of animals per sex per dose:
no data

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
: The dermal absorption potential of the chemical is expected to be low considering that the molecular weight of 1310 Daltons. In pharmacokinetics, it is considered that the molecular weight (MW) of a compound must be under 500 Dalton to allow effective skin absorption. Considering the use of the chemical for industrial application, the dermal route seems to be the most likely route of exposure. Absorption via the inhalation route is unlikely considering the low vapour pressure of the chemical as indicated above. Absorption through the oral route is also very unlikely
Details on distribution in tissues:
Considering the high water solubility of the chemical, even if the chemical is accidentally absorbed, it shall be distributed by the blood. The lower solubility of this chemical in organic solvents shall not result in transfer to the other parts of the living system through the lipids
Details on excretion:
Considering the high water solubility of the chemical and its large size, it is most likely to be excreted out of the living system unchanged. The lower lipid solubility of this chemical

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: The chemical is expected to have low bio-accumulation potential based upon the relevant physico-chemical parameters as well as BCF factor that can influence the absoprtion, distribution, metabolism and excretion of the chemical outside the living system.
The chemical is expected to have low bio-accumulation potential based upon the relevant physico-chemical parameters as well as BCF factor that can influence the absoprtion, distribution, metabolism and excretion of the chemical outside the living system.
Executive summary:

Absorption:The dermal absorption potential of the chemical is expected to be low considering that the molecular weight of 1310 Daltons. In pharmacokinetics, it is considered that the molecular weight (MW) of a compound must be under 500 Dalton to allow effective skin absorption. Considering the use of the chemical for industrial application, the dermal route seems to be the most likely route of exposure. Absorption via the inhalation route is unlikely considering the low vapour pressure of the chemical as indicated above. Absorption through the oral route is also very unlikely.

Distribution: Considering the high water solubility of the chemical, even if the chemical is accidentally absorbed, it shall be distributed by the blood. The lower solubility of this chemical in organic solvents shall not result in transfer to the other parts of the living system through the lipids.

Metabolism: High molecular weight chemicals are expected to be metabolized with difficulty and excreted out of the living system unchanged. Also the partition co-efficient of this chemical is very low (Log Pow = -1.970) suggesting limited bioavailability for metabolism.

Excretion: Considering the high water solubility of the chemical and its large size, it is most likely to be excreted out of the living system unchanged. The lower lipid solubility of this chemical