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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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RPA 405217, product : Dimethyl Benzylidène Cyclo Pentanone
- Substance type: yellowish powder
- Analytical purity: 96.5 %
- Purity test date: 13.01.1992
- Lot/batch No.: 07/W
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Sprague-Dawley rats
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 178 ± 5 g for the males und 155 ± 7 g for the females
- Fasting period before study: The day before treatment, the animals were fasted for a period of approximately 18 hours before administration of the test substance. They were then given food 4 hours after treatment
- Housing: animais were kept in a conventional air-conditioned animal room ; aninals were housed in groups of 4 to 7 animals of the same sex during the acclimatisation period and groups of 5 animals of the same sex during the study , they were housed in sterilizable polycarbonate cages (48 x 27 x 20 cm) covered with a stainless steel lid containing food and a water bottle
- Diet (ad libitum): yes, except during fasting ; with a certified pellet diet "Rats - Mice sustenance ref. A04 C" (U.A.R. 91360 Villemoisson-sur-Orge, France). An analysis of the quality of the food und the major contaminants (pesticides, heavy metals, mycotoxins, etc.) was performed by the supplier und given for each batch.
- Water (ad libitum): free access to tap water filtered by a 0.22 micron filter membrane, chemical analyses were made periodically
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity: 50 ± 20 % relative humidity
- Air : The air was non-recycled and filtered by absolute filters.
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of 0.5 % Methylcellulose: water
Details on oral exposure:
The vehicle used was an aqueous solution of 0.5 % Methylcellulose: water for injections, batch No. 1336 (Biosédra, 92240 Malakoff, France) and
Methylcellulose MC 4000 M., batch No. 90964 (Prolabo, 75526 Paris, France)

The test substance was administered suspended to the animals at a dose level of 2000 mg/kg at a volume of 10 ml/kg.
The administration was performed in a single dose by oral route using a stainless steel round-shaped probe (diameter: 18 0.2" - Perfektum: Poffer & Sons Inc., New Hyde Park - New York 11040, U.S.A.) fitted to a glass syringe (0.02 ml graduations-Record, Carrieri, 75005 Paris, France).
Doses:
- 2000 mg/kg bw at a volume of 10 mL/kg bw
No. of animals per sex per dose:
- 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Mortality was checked frequently just after application of the test substance and then at least twice a day during the 14-day observation period
- Frequency of observations and weighing: The animals were observed frequently after administration of the test substance and at least once a day tor 14 days in order to determine the reversibility or irreversibility of any clinical signs. The animals were individually weighed just before administration of the test substance und then on days 5, 8 und 15. The body weight gain of the treated animals was compared to a reference curve of the C .I.T. control animals with the same initial weight.
- Necropsy of survivors performed: yes
On the 15th day, the surviving animals were sacrificed after CO2 inhalation in excess and a necropsy was performed. After opening the thoracic and abdominalcavities, a macroscopic examination of the main organs was performed: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities.
- Due to the absence of macroscopic lesions no organ samples were taken and no histological examination was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the observation period.
Clinical signs:
No clinical signs vere observed during the study.
Body weight:
The body weight gain of the animais was normal.
Gross pathology:
The macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormality.
Due to the absence of macroscopic lesions, no samples were talcen for histological examinations.

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study (Rhone-Poulenc, 1992)

according to OECD Guideline 401

(E)-5[(4 - chlorophenyl)methylene]-2,2 - dimethylcyclopentanone

(95.6 %) was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). The test substance was administered suspended in 0.5 % methylcellulose at a dose level of 2000 mg/kg bw at a volume of 10 mL/kg. The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of the test substance. A necropsy was performed on each animal sacrificed at the end of the study. The general behaviour and body weight gain of the animals were not influenced by the treatment. No deaths occurred at the dose level of 2000 mg/kg. The macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.

Thus, the LD 0 of the test substance administered by oral route in rats was higher than or equal to 2000 mg/kg.

No signs of toxicity were observed at this dose level.