Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
n/a
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
E-AF098T (Lot No. T 157), a white powder. Stored at room temp. (Approximately 25oC).
The test material was stable for the duration of the study.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: Charles River Laboratories, Inc.
Male and nulliparous, nongravid female. Age: Approximately 7 weeks old. Bodyweight: 187-208 gr males, 155-176 gr femaels). Daily average animal
room temperature and relative humidity: 69 ± 2oF and 67± 5%, respectively.
Identification by Earmark.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Corn oil (50% formulation)
Details on oral exposure:
Oral gavage, using a syringe equipped with a stainless steel ball-tipped intubation needle. Dosing volume of 10 ml/kg body weight.
Fasting Food was withheld overnight prior to dosing until approx. 4 hours after administration of the test substance.
Frequency: Single dose on day 1. 14 days observation.
Doses:
5 gr/kg (5000 mg/kg) of fasted body weight using a dosing volume of 10 ml/kg body weight.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
All animals were dosed 5000mg/kg bodyweight, once only, by gavage. The animals were observed for mortality/moribundity or over sight of toxicity for 14 days. At the end of the study, the animals were killed and subjected to gross pathological examination.

Frequesncy of observation:
Mortality/Viability- Twice daily
Body weights- Days 1 (pre administration), 8 and 15.
Clinical signs- At periodic intervals on day of dosing (day 1) and once daily thereafter.until day 15.
Necropsy- At the end of the observation period, all animals were sacrificed by asphyxiation using oxygen/carbon dioxide procedure and subjected
to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
Statistics:
Statistical analysis was limited to calculation of means and standard deviations of body weight and body weight change.

Results and discussion

Preliminary study:
n/a
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None of the rats died during the study
Clinical signs:
No clinical signs of toxcity were observed in any of the animals for the duration of the study.
Body weight:
All rats gained weight during the study.
Gross pathology:
No gross necropsy findings were observed
Other findings:
no further information

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The Acute oral toxicity test of Fyrolflex SOL-DP (E-AF098T) was conducted in male and female rats. There were no deaths during the study. No signs of systemic toxicity were noted. No macroscopic abnormalities were detected. The acute oral median lethal dose (LD50) of the test material in the Sparague- Dawley CD strain rat was found to be greater than 5000 mg/kg body weight.