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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:
October 26, 2009 / November 13, 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate
EC Number:
241-527-8
EC Name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate
Cas Number:
17527-29-6
Molecular formula:
C11H7F13O2
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate
Test material form:
liquid
Details on test material:
Pale yellow liquid
Purity: 91.69%
pH: 7.0
Stability: The test substance was expected to be stable for the duration of testing
The test substance was stored at room temperature.
Specific details on test material used for the study:
Physical description: Pale yellow liquid
pH: 7.0 (as determined)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Sex: Female, nulliparous and non-pregnant.
Age/Body weight: Young adult (11 weeks)/199- 223 grams at experimental start.
Source: Received from Ace Animals, Inc., Boyertown, PA on October 6, 2009.
Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NRC). Enrichment (e.g. nylabone) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature and Relative Humidity Ranges: 19 - 21 ºC and 35 - 69%, respectively.
Photoperiod: 12-hour light/dark cycle.
Acclimation Period: 22 or 24 days
Food: Purina Rodent Chow #5012
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file at Eurofins PSL.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3 - 4 hours after dosing.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
Prior to each dosing, experimentally naive rats were fasted overnight by removing the feed from their cages. During the fasting period, the rats were examined for health and weighed (initial). Three healthy naive female rats (not previously tested) were selected for test.
Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing.
The animals were observed for mortality, signs of gross toxicity, and behavioral changes approximately 30 minutes post-dosing, during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived
Clinical signs:
No clinical signs were shown by animals during the study
Body weight:
All animals gained body weight
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test item induced no effects in 3 female rats after oral gavage at a dose of 5000 mg/kg bw.
LD50 has been determined to be greater than 5000 mg/kg bw.
According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required.
Executive summary:

An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for test item to produce toxicity from a single dose via the oral route. An initial limit dose of 5000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional females received the same dose level, simultaneously.

Since these animals survived, no additional animals were tested. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at terminal sacrifice. All animals survived, gained body weight, and exhibited no clinical signs during the study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Under the conditions of this study, the acute oral LD50 of the test substance is greater than 5000 mg/kg of body weight in female rats.

According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required

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