Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity
Author:
Jenner PM, Hagan EC, Taylor JM, Cook EL, Fitzhugh OG
Year:
1964
Bibliographic source:
Food and Cosmetics Toxicology (2) pp327-343
Report date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of rats fed test material and observed for 14 d.
GLP compliance:
no
Remarks:
Study predates GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanal
EC Number:
203-957-4
EC Name:
Decanal
Cas Number:
112-31-2
Molecular formula:
C10H20O
IUPAC Name:
decanal
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C-10 decyl (decanal)
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: approx. 18 hr
- Housing: In cages
- Diet: Ad libitum (except fasting period)
- Water: Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Doses:
No data
No. of animals per sex per dose:
5 male, 5 female per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs
Statistics:
LD₅₀ values were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 33 320 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Highest dose administered
Mortality:
No
Clinical signs:
Excitation, diarrhoea, wet fur on stomach and posterior
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for acute oral toxicity using rats in a standard acute toxicity method. The acute oral LD₅₀ of the test substance to rats was >33320 mg/kg bw (the highest dose administered).