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Diss Factsheets

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:
data from handbook or collection of data
Justification for type of information:
Data is from publication.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute oral toxicity study of the test chemical
Author:
Jenner et al
Year:
1964
Bibliographic source:
Fd Cosmet. Toxicol.
Reference Type:
publication
Title:
Assessment Report - Test chemical
Author:
ADAMS et al.
Year:
1996
Bibliographic source:
Food and Chemical Toxicology
Reference Type:
review article or handbook
Title:
Toxicity Studies on rodents
Author:
Richard J. Lewis
Year:
1989
Bibliographic source:
Food Additives Handbook
Reference Type:
publication
Title:
TOXICOLOGICAL EVALUATION OF TEST CHEMICAL
Author:
WORLD HEALTH ORGANIZATION
Year:
1984
Bibliographic source:
WORLD HEALTH ORGANIZATION
Reference Type:
publication
Title:
SAFETY EVALUATION OF CERTAIN FOOD ADDITIVES
Author:
World Health Organization
Year:
1999
Bibliographic source:
World Health Organization
Reference Type:
publication
Title:
Toxicological Evaluation of Certain Food Additives
Author:
WHO
Year:
1980
Bibliographic source:
WHO

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Acute oral toxicity study of the given test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
EC Number:
204-841-6
EC Name:
4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
Cas Number:
127-41-3
Molecular formula:
C13H20O
IUPAC Name:
4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
Details on test material:
- IUPAC Name: 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Common Name: alpha-Ionone
- InChI: 1S/C13H20O/c1-10-6-5-9-13(3,4)12 (10)8-7-11(2)14/h6-8,12H,5,9H2,1-4H3/b8-7+
- Smiles: C1([C@@H](C(=CCC1)C)\C=C\C(C)=O) (C)C
- Molecular formula:C13H20O
- Molecular weight :192.3 g/mole
- Substance type:Organic
- Physical state:Colorless oil, woody, violet odor

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
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: Young rats were used for the study
- Weight at study initiation: No data
- Fasting period before study: 18 hrs prior to treatment
- Housing: Animals were housed in cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): 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

IN-LIFE DATES: From: To: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4590 mg/Kg bw
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION (if unusual): No data

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data
Doses:
4590 mg/kg bw
No. of animals per sex per dose:
10 rats evenly divided by sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for recording toxic signs artd time of death. Such observation was continued until animals appeared normal and showed weight gaiu.
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No data
Statistics:
LD50'S were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 590 mg/kg bw
Based on:
test mat.
95% CL:
> 3 880 - < 5 400
Mortality:
50% mortality was observed at 4590 mg/kg bw. Death time was 4 hrs - 4 days
Clinical signs:
other: Depression, tremors
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) value was considered to be 4590 mg/kg bw, when rats were treated with the given test chemical via oral gavage route of exposure.
Executive summary:

Acute oral toxicity study was conducted for the test chemical using male and female Osborne Mendel rats at the dose concentration of 4590 mg/kg bw via oral gavage route of exposure. Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hr prior to treatment. Animals had access to water at all times, and the food was replaced in cages as soon as animals received their respective doses. All doses were given by intubation. All animals were maintained under close observation for recording toxic signs artd time of death. Such observations were continued until animals appeared normal and showed weight gain. The test chemical showed depression and tremors and the death time was 4 hrs to 4 days. 50% mortality was observed at 4590 mg/kg bw. Hence, the LD50 value was considered to be 4590 mg/kg bw, when rats was treated with the given test chemical via oral gavage route of exposure.