Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from Authoritative Publication

Data source

Reference
Reference Type:
publication
Title:
THE METABOLISM OF ALKYLBENZENES. ISOPROPYLBENZENE (CUMENE) AND DERIVATIVES OF HYDRATROPIC ACID
Author:
D. ROBINSON, J. N. SMITH AND R. T. WILLIAMS
Year:
1955
Bibliographic source:
Biochemical Journal Jan 01, Year 1955,volume 59(1) pages 153-159

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Details of guidelines is not mentioned in the publication.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
CAS No: 93-53-8
Chemical Name: Hydratropaldehyde (Synonym: Hydratropic aldehyde)
Nature of chemical: Organic
Radiolabelling:
no

Test animals

Species:
rabbit
Strain:
Chinchilla
Sex:
not specified
Details on test animals and environmental conditions:
Chinchilla rabbits kept on a constant diet were used.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
Chinchilla rabbits kept on a constant diet were used. Compound were administered suspended in water by stomach tube.
Duration and frequency of treatment / exposure:
A total of 18 g. of the aldehyde was fed to six rabbits, and the urine was collected for 24 hr.
Doses / concentrations
Remarks:
Doses / Concentrations:
18 g
No. of animals per sex per dose:
6 rabbits
Control animals:
not specified
Positive control:
No data
Details on study design:
No data
Details on dosing and sampling:
No data
Statistics:
No data

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
No details available
Type:
distribution
Results:
No details available
Type:
metabolism
Results:
Hydratropoylglucuronide is formed when (± )hydratropic aldehyde is fed to rabbits. Hydratropoylglucosiduronic acid & Hydratropyl alcohol is also formed.
Type:
excretion
Results:
It is reported that the metabolites are excreted through the urine.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Hydratropoylglucuronide
Hydratropoylglucosiduronic acid &
Hydratropyl alcohol

Any other information on results incl. tables

However, the summary of evaluations performed by the Joint FAO/WHO Expert Committee on Food Additives (Jan 2006) for 2-PHENYLPROPIONALDEHYDE (Synonym for Hydratropic aldehyde) when used as a food additive, indicate no safety concern at current levels of intake when Hydratropic aldehyde is used as a flavouring agent.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
This study does not mention in details about the absorption, distribution, metabolism and excretion of the chemical Hydratropic aldehyde, when fed by stomach tube to Chinchilla rabbits. The study indicates that upon administration of Hydratropic aldehyde, the metabolites Hydratropoylglucuronide, Hydratropoylglucosiduronic acid & Hydratropyl alcohol are formed which are excreted out of the body of rabbit via urine. However, in the absence of the information of the % recovery of the administered test chemical, it is not possible to conclude on the bio-accumulation potential of Hydratropic aldehyde.
However, the summary of evaluations performed by the Joint FAO/WHO Expert Committee on Food Additives (Jan 2006) for 2-PHENYLPROPIONALDEHYDE (Synonym for Hydratropic aldehyde) when used as a food additive, indicate no safety concern at current levels of intake when Hydratropic aldehyde is used as a flavouring agent.
Thus considering the above, it can be concluded that since Hydratropic aldehyde is metabolized in the study with rabbits, the chemical is expected to exhibit Low bioaccumulation potential.
Executive summary:

The available data does not mention in details about the absorption, distribution, metabolism and excretion of the chemical Hydratropic aldehyde, when fed by stomach tube to Chinchilla rabbits. The study indicates that upon administration of Hydratropic aldehyde, the metabolitesHydratropoylglucuronide, Hydratropoylglucosiduronic acid & Hydratropyl alcohol are formed which are excreted out of the body of rabbit via urine. However, in the absence of the information of the % recovery of the administered test chemical, it is not possible to conclude on the bio-accumulation potential ofHydratropic aldehyde.

However, the summary of evaluations performed by the Joint FAO/WHO Expert Committee on Food Additives (Jan 2006) for 2-PHENYLPROPIONALDEHYDE (Synonym forHydratropic aldehyde) when used as a food additive, indicate no safety concern at current levels of intake when Hydratropic aldehyde is used as a flavouring agent. Thus considering the above, it can be concluded that since Hydratropic aldehyde is metabolized in the study with rabbits, the chemical is expected to exhibit Low bioaccumulation potential.