3-methyl-5-propylcyclohex-2-enone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

22 October - 19 November 1981

Reliability:

2 (reliable with restrictions)

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Principles of method if other than guideline:

Ten male rabbits were used, one was outside the specified weight range. Animals were housed in pairs.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

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:

rabbit

Strain:

other: albino

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: 2.1-3.2 kg
- Fasting period before study: No data
- Housing: suspended wire mesh cages (2 animals/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): No data

IN-LIFE DATES: From: 22 October 1981 To: 19 November 1981

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: 10
- Type of wrap if used: plastic, secured with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): application site was wiped after patch removal
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 g/kg
- Concentration (if solution): No data
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of exposure:

24 hours

Doses:

5.0 g/kg

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were scored for dermal irritation 24 hours, 7 and 14 days after dose administration
- 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

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died on day 2 of the experiment

Clinical signs:

other: Ptosis, lethargy, few feces, diarrhea, intestine abnormalities

Gross pathology:

Severe edema observed in majority of animals after 24 hours, severity was reduced after 14 days. Eschar formation was most severe on day 7

Other findings:

No data

Any other information on results incl. tables

Dose level (g/kg)	Number of animals	Number of mortalities	Day of death
5.0	10	1	2

Applicant's summary and conclusion

Conclusions:

The acute dermal toxicity of celery ketone was assessed using a group of ten male rabbits. The LD50 was calculated as being greater than 5.0 g/kg by the method of Litchfield and Wilcoxon.

Executive summary:

The acute dermal toxicity of celery ketone was assessed using a group of ten male rabbits dosed by skin application at 5.0 g/kg in a method similar to OECD TG 402 (no guideline specified). The LD50 was calculated as being greater than 5.0 g/kg by the method of Litchfield and Wilcoxon. Thes test article was considered to be not toxic to the skin.