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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Description of key information

Bioaccumulation potential: no bioaccumulation potential
Absorption rate - oral (%): 50
Absorption rate - dermal (%): 50
Absorption rate - inhalation (%): 100

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
50
Absorption rate - dermal (%):
50
Absorption rate - inhalation (%):
100

Additional information

Assessment of Toxicokinetics based on the physicochemical properties ofCineole:

 

Endpoint waiver statement:

 

Although REACH does not specifically require generation of toxicokinetic information, it does require that all relevant available information is used to assess the toxicokinetic behaviour of a substance, and that human health hazard assessment considers the toxicokinetic profile of the substance.

 

Cineoleis a small organic molecule and the physico-chemical properties suggest it is likely to be absorbed via dermal, inhalation and gastric routes following exposure.

Acute and subchronic toxicity data indicate that Cineole is absorbed following administration by gavage and metabolised by the liver. No specific studies on the absorption, distribution, metabolism and elimination (ADME) of are available. However the very low toxicity of Cineole suggests that it may be considered inappropriate at this time to conduct further animal work to support ADME.

 

Endpoint Summary:

 

Cineole: (Target)

Molecular weight: 154.25 Da

Water solubility: 2397 mg/L in ultrapure water

Partition coefficient: log Kow = 3.4

 

The following remarks on the toxicokinetics of Cineole are based on the available studies and the read-across substance Clarycet.

 

Experimental toxicokinetic studies were not available.

No specific studies on the absorption, distribution, metabolism and elimination (ADME) of Cineole are available. However the very low toxicity of Cineole suggests that it may be considered inappropriate at this time to conduct further animal work to support ADME.

 

ABSORPTION

The physicochemical characteristics of Cineole (log kow3.4) and the molecular mass are in a rangesuggestive of absorption from the gastro-intestinal tract subsequent to oral ingestion. This assumption of oralabsorption is confirmed by the data from the subchronic oral toxicity.

 

N-octanol/water partition coefficient and molecular weight of Cineole are in ranges which favourdermal absorption.

 

DISTRIBUTION and METABOLISM

As a small molecule a wide distribution is expected. This assumption is confirmed by the changes shown in therepeated dose toxicity studies following oral application.

 

ELIMINATION

The n-Octanol/water partition coefficient (log kow 3.4) is suggestive of accumulation of unchanged Cineole in fatty tissues subsequent to absorption from gastrointestinal tract or from lungs.

 

The following information is taken into account for any hazard / risk assessment:

 

Experimental toxicokinetic studies are not available. The log kow 3.4)is suggestive of accumulation ofunchanged Cineole in fatty tissues subsequent to absorption from gastro-intestinal tract or from lungs.

 

Value used for CSA:

Bioaccumulation potential: no bioaccumulation potential

Absorption rate - oral (%): 50

Absorption rate - dermal (%): 50

Absorption rate - inhalation (%): 100

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