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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
weight of evidence
Study period:
28 October - 30 November 1981
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No guideline specified but procedure listed is similar to OECD Test Guideline 423: Acute toxic class method. Study was conducted according to GLP (certificate not included).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Principles of method if other than guideline:
Initial dose was set at 5.0 g/kg and only two further doses were tested. Male rats were used (guideline suggests females as they are generally more sensitive).
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Celery ketone
IUPAC Name:
Celery ketone
Constituent 2
Reference substance name:
3-Methyl-5-propyl-2-cyclohexen-1-one
IUPAC Name:
3-Methyl-5-propyl-2-cyclohexen-1-one
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 3 Methyl 5 propyl 2 cyclohexen 1 one
- Substance type: No data
- Physical state: clear liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: 3 Methyl 5 propyl 2 cyclohexen 1 one (unspecified percentage)
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 81-19
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: ambient room temperature and humidity in a container

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: No data
- Weight at study initiation: 211-275 g
- Fasting period before study: 16-20 hours
- Housing: suspended wire mesh cages (5/cage)
- Diet (e.g. ad libitum): 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): 12/12

IN-LIFE DATES: From: 28 October 1981 To: 30 November 1981

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION (if unusual): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data
Doses:
1.2, 1.9, 5.0 g/kg
No. of animals per sex per dose:
10
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: yes
- Other examinations performed: clinical signs
Statistics:
LD50 (and 95% Confidence Levels) were calculated by the method of Litchfield and Wilcoxon

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 700 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 800 - <= 4 100
Mortality:
Nine out ten animals in the the highest dose group died during the observation period. One animal death was reported in each of the two other dose groups.
Clinical signs:
Coma, tremors, lethargy, ataxia, prostration, dyspnea, negative righting reflex
Body weight:
No data
Gross pathology:
Abnormalities of the heart, lungs, gastro-intestinal tract, urinary tract as well as breown staining of the anogenital and nose/mouth areas.
Other findings:
Not applicable

Any other information on results incl. tables

 Dose level (g/kg)  Group size  Mortality  Day of death      
       0  1  2
 5.0  10  9  1  5  3
 1.2  10  1  0  1  0
 1.9  10  1  0  1  0

Applicant's summary and conclusion

Conclusions:
The acute oral toxicity of celery ketone was assessed using gavage dosing of male rats. The LD50 was calculated as 2.7 g/kg (95% CL: 1.8 to 4.1 g/kg).
Executive summary:

The acute oral toxicity of celery ketone was assessed using groups of ten male rats dosed by gavage in a method similar to OECD TG 423 (no guideline specified). The LD50 was calculated as 2.7 g/kg (95% CL: 1.8 to 4.1 g/kg) by the method of Litchfield and Wilcoxon.

See attached in section 13, a read-across justification document for the use of Celery Ketone in read-across for Azarbre.