Registration Dossier
Registration Dossier
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EC number: 615-240-7 | CAS number: 710292-85-6
Endpoint summary
Administrative data
Link to relevant study record(s)
- 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
- Objective of study:
- other: toxicokinetic assessment
- Principles of method if other than guideline:
- Assessment of all available data
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: none
- Strain:
- other: none
- Route of administration:
- other: oral, dermal and inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- see assessment
- Type:
- other: see conclusions
- 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.
Reference
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.
Description of key information
Oral and dermal absorption are estimated at 100% while absorption via inhalation is negligible.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 0
Additional information
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.
For risk assessment purposes, the oral and dermal absorption for the substance are set at 100% while the absorption via inhalation is considered to be negligible.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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