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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
other: literature review
Adequacy of study:
other information
Study period:
2013
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: literature review
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Principles of method if other than guideline:
Literature review

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

See executive summary.

An inhalation acute toxicity test should not be required.

Applicant's summary and conclusion

Executive summary:

CAE is defined as an UVCB substance (substance of unknown or variable composition). Its detailed chemical characterisation is presented in Table 1 (see PDF document attached).

The final complex is composed of glycerides (46.3%), free fatty acids and unsaponifiables such as alkyl furans, alkyl triols. More particularly alkyl furans are the result of chemical reaction during the heat treatment and are not found naturally in the fruit.

 

CAE was not experimentally tested for all requested toxicological end-points.

Glycerides and free fatty acids are very well-known substances which are not of toxicological concern. On the contrary, alkyl furans and alkyl triols, respectively named fraction H and fraction I, which are less well known, could raise questions about the toxicological profile of CAE.

 

In order to avoid unnecessary experimentation on animals, a literature review was performed for each component to determine their acute inhalation toxicity properties. The results are summarized in Table 2 (see PDF document attached).

 

According to available data, glycerides and free fatty acids have no inhalation acute toxicity. Other components are either of slight acute toxicity like alkyl furans with LC50expected between 1 and 4 mg/L/hr or of unknown toxicity like alkyl triols.

However all of these components have low vapour pressures (alkylfurans: 10-1-10-2 Pa), or extremely low vapour pressures (alkyl triols < 10-6 Pa).

Therefore, according to § 8.5.2. Column 2 in Annex VIII to Regulation (EC) No.1907/2006, testing by the inhalation route is not appropriate as exposure of humans via inhalation is unlikely, taking into account the low vapour pressure of the substance and the reduced possibility of exposure to aerosols, particles or droplets of an inhalable size (confinement during the manufacturing process).

An inhalation acute toxicity test should not be required.