Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 15, 1998 - December 29, 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

yes

Remarks:

Limited details on test material, no purity, no details on environmental conditions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

EC Number:

944-482-9

Molecular formula:

C13H20O

IUPAC Name:

Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Sprague Dawley derived

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USDA License #23-B-009
- Age at study initiation: No data
- Weight at study initiation: males: 238 - 253g; females: 209 - 241g
- Fasting period before study: fasted overnight for approx. 18-24 hours prior to dosing
- Housing: Animals were either single or double housed in suspended stainless steel wire-mesh cages
- Diet: Free access to Agway Prolab 3000
- Water: Free access to city water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS set to maintain
- Temperature (°C): targeted 21
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Individual doses, calculated on the basis of bodyweight and test material density (0.93 g/mL), were administered by syringe and suitable intubation tube.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight: just prior to administration and weekly thereafter
Toxicity and mortality: twice daily seven days a week after administration
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male was found dead on day 7.

Clinical signs:

On day 1 in the morning, all animals had decreased locomotion. One female and two males appeared dehydrated therefore all animals were given a water bottle. On day 1, in the afternoon, one female had decreased locomotion, all other animals appeared normal.

Body weight:

All surviving animals showed normal bodyweight increases on the 14th day of the observation period.

Gross pathology:

There were no gross abnormalities in any of the surviving animals. One male was found to have both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

The acute oral toxicity test with the substance showed an LD50 of >2000 mg/kg bw.

Executive summary:

In this study performed according to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered with the substance at a dose level of 2000 mg/kg bw. One male was found dead on day 7. On day 1 in the morning, all animals had decreased locomotion. One female and two males appeared dehydrated therefore all animals were given a water bottle. On day 1, in the afternoon, one female had decreased locomotion, all other animals appeared normal. There were no gross abnormalities in any of the surviving animals. One male was found to have both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008.