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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:
From December 15 to 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)
Deviations:
yes
Remarks:
(age at study initiation and some environmental conditions of animal room not reported)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
EC Number:
260-486-7
EC Name:
1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
Cas Number:
56973-85-4
Molecular formula:
C13H20O
IUPAC Name:
1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Constituent 2
Chemical structure
Reference substance name:
1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Cas Number:
56973-84-3
Molecular formula:
C13H20O
IUPAC Name:
1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Test material form:
liquid
Remarks:
clear, pale yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not reported
- Weight at study initiation: Males: 1200 - 300 g; females: 200 - 300 g.
- Fasting period before study: the rats were fasted overnight for approximately 18-24 hourss prior to dosing
- Housing: Animals were either single or double housed in suspended stainless steel wire-mesh cages
- Diet: Agway Prolab 2000 rodent feed, ad libitum
- Water: city water, ad libitum
- Acclimation period: at least 7 days prior to the start of testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature targeted at 21°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
-- Other: during the acclimation and testing perods, each animal was housed and maintained according to The Guide For The Care and Use of Laboratory Animals (NIH 86-23)

IN-LIFE DATES: not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: not applicable

MAXIMUM DOSE VOLUME APPLIED:
Dose Volume (ml) = [animal weight (kg) x limit dose (2 g/kg)] / Test material density (0.93 g/l)
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 was recorded in grams for each animal just prior to administration of test substance and weekly thereafter. Body weights were also recorded prior to scheduled sacrifices. All test animals were observed for signs of toxicity and mortality twice daily seven days a week after test material admnistration during two weeks. Observations included the following: circulatory, autonomic and central nervous system, somatomotor activity, behavior patterns, skin and fur, and eyes and mucous membranes.
- Necropsy of survivors performed: Yes; a gross necropsy was performed on all surviving test animals 14 days after dosing. The animals were sacrificed with CO2.
Tissue samples for possible histological examination were taken from each of the ten animals. Tissues taken and preserved in 10% formalin were the lungs, both kidneys and representative sections of the liver.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Only one mortality was observed.
Mortality:
- Nine of ten animals survived the 14 day test. On day 7, male # 9901 was found dead.
Clinical signs:
- On day 1 in am, all animals had decreased locomotion;female #9894 and males #9900 and 9901 appeared dehydrated therefore all animals were given a water bottle. On day 1, at afternoon observations, female #9894 had decreased locomotion, all others appeared normal. There were no other clinical observations noted, all animals appeared normal throughout the 14 day study period.
Body weight:
- All surviving animals had a weight gain by day fourteen of the study period.
Gross pathology:
- There were no gross abnormalities in any of the surviving animals at necropsy.
- Male #9901 was found to have both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 Combined > 2000 mg/kg bw. Not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
Executive summary:

In an acute oral toxicity study (limit test), performed according to OECD Guideline No. 401 and in compliance with GLP, a group of Sprague Dawley rats (5/sex) were administered a single oral dose of undiluted test material at 2000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No clinical signs were observed. One animal was found dead at day 7. All surviving animals showed normal body weight gains after the 14 day study period. No abnormalities were noted at autopsy in the surviving animals. The animal found dead at day 7 has both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas.

Oral LD50 Combined > 2000 mg/kg bw  

Under the test conditions, the test material is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and is not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.