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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
Study period:
April 18-June 13, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Federal Hazardous Sbustances Act, CFR 16, Section 1500.3
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
EC Number:
268-706-3
EC Name:
2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
Cas Number:
68133-79-9
Molecular formula:
C15H24O
IUPAC Name:
2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Buckshire Corp., Perkasie, Pennsylvania 18944, USA
- Weight at study initiation: 200-232 g
- Fasting period before study: overnight
- Housing: Stainless steel cages with mesh flooring, 5 rats per cage single sex
- Diet (e.g. ad libitum): Wayne Rodent-Blox ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 degrees C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: May 8, 1991 To: May 22, 1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 g/kg
Doses:
5 g/kg
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: 2x per day on day of dosing and day after, at least daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology
Statistics:
Mean, standard deviation

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: All females exhibited ruffled fur the day after dosing, and the morning after that. By the afternoon of day 2, all females appeared normal. All males exhibited body and genital staining, and ruffled fur the day after dosing. They also exhibited ruffled
Gross pathology:
No gross abnormalities were seen in any animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 in rats is > 5,000 mg/kg.
Executive summary:

The acute oral toxicity of the test substance was determined in a 14 -day study in rats. 5 male and 5 female rats were given a single dose of 5 g/kg, and observed for the next 14 days. All animals were necropsied at the end of the study. There were minor clinical signs observed on the day after dosing in all animals, but all signs had resolved by the afternoon of the next day. There was no mortality during the study period. The acute oral LD50 of the test substance is therefore > 5000 mg/kg.