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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
other: A written assessment based on toxicological profile of the substance
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A written assessment of toxicokinetic behaviour is considered appropriate for the substance. The substance displays only minor toxicological effects in any of the studies proposed, and is deemed to be be not harmful for health effects. As such, it is deemed inappropriate in terms of animal welfare to conduct a toxicokinetic assessment when no harmful effects are predicted based on known toxicology. A written assessment has therefore been prepared to address this endpoint.

Data source

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Principles of method if other than guideline:
Written assessment based on toxicological profile.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tripropan-2-ylsilyl 2-methylprop-2-enoate
EC Number:
700-182-8
Cas Number:
134652-60-1
Molecular formula:
C13 H26 O2 Si
IUPAC Name:
Tripropan-2-ylsilyl 2-methylprop-2-enoate
Details on test material:
Not applicable

Test animals

Species:
other: Not applicable
Details on test animals or test system and environmental conditions:
Not applicable

Administration / exposure

Details on exposure:
Not applicable
Duration and frequency of treatment / exposure:
Not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
Not applicable
No. of animals per sex per dose / concentration:
Not applicable
Positive control reference chemical:
Not applicable
Details on study design:
Not applicable
Details on dosing and sampling:
Not applicable
Statistics:
Not applicable

Results and discussion

Preliminary studies:
Not applicable

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not applicable
Details on distribution in tissues:
Not applicable
Details on excretion:
Not applicable

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
Not applicable

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Executive summary:

CONCLUSION

The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of TIS-M. Based on all available data, TIS-M has a low acute toxicity potential.

 

Systemic effects observed in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test suggest that absorption of TIS-M does take place orally. The results from all studies with dermal exposure indicate that TIS-M has limited dermal absorptive potential.

 

TIS-M is insoluble in water and undergoes rapid hydrolysis in water therefore it is highly unlikely to be eliminated in its unchanged form. Based on the negative mutagenicity and chromosome aberration assays, the possibility of metabolism to genotoxic sub-structures can most probably be excluded.

 

Bioaccumulation of TIS-M can most probably be excluded due to the fact that the substance rapidly hydrolyses in water, and has a high log Pow value that is attributable to extremely low water solubility rather than actual bioaccumulation potential.