Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: assessment based on available information.
Adequacy of study:
key study
Study period:
June 2010
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:
2010
Report Date:
2010

Materials and methods

Objective of study:
other: toxicokinetic assessment
Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VC
- Molecular formula (if other than submission substance): C3H2O3
- Molecular weight (if other than submission substance): 86.05
- Physical state: Clear colourless solid
- Analytical purity: > 99.9% (GC)

Test animals

Species:
other: none
Strain:
other: none

Administration / exposure

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

Results and discussion

Any other information on results incl. tables

The partition coefficient of Vinylene Carbonate is about 0 (log Kow=-0.36), meaning that the substance is about as soluble in water as in octanol. This property of the substance is favourable for absorption. In addition, also the low molecular weight (MW=86.05)and the high water solubility of Vinylene Carbonate (515 g/l at 20.2°C) are favourable for uptake from the gastro-intestinal tract. The combination of low molecular weight with high water solubility are indicative for possible passage of the substance through aqueous pores (1). For risk assessment purposes, the oral absorption is set at 100%. The results of the toxicity studies do not provide reason to deviate from this proposed oral absorption.

Once absorbed, widely distribution of Vinylene Carbonate in the body is expected based on its low molecular weight. The high water solubility together with the low molecular weight is indicative for for the possibility of diffusion through aqueous channels and pores. Once absorbed, Vinylene Carbonate will be hydrolysed. Excretion of Vinylene Carbonate will be mainly via urine and bile (3). Further conclusions on metabolism are difficult to be drawn based on the available data.

As Vinylene Carbonate has a low melting temperature (15°C), the substance is a liquid at ambient temperature, and will be considered as such. The low vapour pressure (335 Pa) and high boiling point (168°C) indicate that the substance will not be available for inhalation as a vapour. For risk assessment purposes, the exposure by inhalation is considered negligible.

The low molecular weight and high water solubility of Vinylene Carbonate is favourable for dermal uptake. The log Pow of about zero, however, is not favourable for dermal uptake. Since the substance has skin irritating properties, enhanced penetration of the substance may be expected due to damage of the skin surface. The criteria for reduced dermal absorption as given in the TGD (2) (MW>500 and log Pow>4) are not met, and therefore 100% dermal absorption of Vinylene Carbonate is proposed for risk assessment purposes.

Based on the present available data, no aditional conclusions can be drawn on the distribution, metabolism and excretion of Vinylene Carbonate after dermal absorption.

 

 


Applicant's summary and conclusion

Conclusions:
Interpretation of results:
For risk assessment purposes, the oral absorption is set at 100%.
For risk assessment puposes the exposure by inhalation is considered negligible.
For risk assessment purposes the dermal absorption is set at 100%.