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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Food Flavorings and Compounds of Related Structure I: Acute Oral Toxicity
Author:
P.M Jenner, E.C Hagan, Jean M Taylor, E. L .Cook and O.G Fitzhugh
Year:
1964
Bibliographic source:
Food Cosmet. Toxicol, Vol 2, pp. 327 -343, 1964

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study was carried out in Osborne- Mendel rats.
GLP compliance:
not specified
Test type:
other: no data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Hydratrophic Aldehyde (2 Phenylpropanal
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: No Data
Age at study initiation: No Data
Weight at study initiation: No Data
Fasting period before study: Rats were fasted approximately 18 hours prior to treatment
Housing: Cages
Diet (e.g. ad libitum): Food was replaced as soon rats were dosed and was available ad libitum
Water (e.g. ad libitum): Water. Ad libitum
Acclimation period: No Data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
MAXIMUM DOSE VOLUME APPLIED: 3500 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
Duration of observation period following administration: The rats were observed for toxic signs for 2 weeks
Frequency of observations and weighing: Daily
Necropsy of survivors performed: No data
Statistics:
The LD50 was computed by the method of Litchfield & Wilcoxon (1949)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Based on:
test mat.
95% CL:
2 390 - 3 280
Mortality:
Death time – 1 – 4 days and Coma within 20 minutes after treatment
Clinical signs:
Rough fur was observed in the treated rats
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral study in rats, the acute oral LD50 for Hydratrophic aldehyde (2 Phenyl propanal) was determined to be 2800 (2390 - 3280) mg/kg
Executive summary:

Acute Oral study was carried out in rats.

Groups of 10 young adult Osborne- Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to treatment. Animals had access to water at all times, All doses were given by intubation.

All animals were maintained under close observation for recording toxic signs and death time. Such observations continued until animals appeared normal and showed weight gain. The observation period was 2 weeks.

THE LD50 were computed by the method of Litchfield and Wilcoxon(1949)

Death time was 1 – 4 days and Coma within 20 minutes after treatment was observed.

The acute oral LD50 for Hydratrophic aldehyde (2 Phenyl propanal) was found to be 2800 (2390 - 3280) mg/kg

According to the CLP regulation the substance was not classified.