Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 29 1982 to January 25 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, carried out according to recognised (older) guideline, results fully documented. Considered appropriate for use based on data available and animal welfare concerns.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consistent with Environmental Protection Agency's Guidelines for registering pesticides in the U.S.: Hazard evaluation: Humans and Domestic Animals, Fed. Reg. 43:163 37336-37402 (1978). and OECD Guidelines (1981)
Deviations:
no
Principles of method if other than guideline:
Sprague-Dawley albino rats were used for test purposes. The test material was either dissolved or suspended in a suitable vehicle. The test material was administered in single doses by means of the gavage tube. A minimum of ten animals were used for each dose level. The animals were fasted for 16-18 hours prior to treatment. The animals were observed for at least 14 days after treatment for mortality and signs of toxicity. Necropsies were performed on all animals that died during the study (with the exception of cannabalized animals) and on all survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fyrquel EHC (Trixylenyl phosphate)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: not specified
- Physical state: liquid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: #9221-J-1-1X
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals used in this study were purchased from Charles River laboratories, Portage, Michigan. No details on environmental conditions are provided.
Males, Weight Range, grams: 182-214
Females, Weight Range, grams: 142-179

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test material was administered in single doses by means of the gavage tube. A minimum of ten animals were used for each dose level. The animals were fasted for 16-18 hours prior to treatment.
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Sprague-Dawley albino rats were used for test purposes. The test material was either dissolved or suspended in a suitable vehicle. The test material was administered in single doses by means of the gavage tube. A minimum of ten animals were used for each dose level. The animals were fasted for 16-18 hours prior to treatment. The animals were observed for at least 14 days after treatment for mortality and signs of toxicity. Necropsies were performed on all animals that died during the study (with the exception of cannabalized animals) and on all survivors.
Statistics:
None reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
0/10 per sex
Clinical signs:
Males: A single dose of 5000 mg/kg produced no mortalities. Adverse clinical signs for all rats included mild depression, piloerection, wet fur, diarrhea, yellowish anogenital stains, evidence of excessive urination, and red facial stains. All rats appeared normal by day 7.

Females: A single dose of 5000 mg/kg produced no mortalities. Adverse clinical signs for all rats included mild to moderate depression, piloerection, ataxia, evidence of excessive urination, and red-stained muzzles. All rats appeared normal on day 6.
Body weight:
Not reported.
Gross pathology:
All rats were necropsied following termination on Day 14 and appeared normal.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for Fyrquel EHC (Trixylenyl Phosphate) given to male albino rats was >5000 mg/kg. Commonly observed adverse clinical signs included depression, piloerection, wet fur, diarrhea, yellow anogenital stains, evidence of excessive urination, and red facial stains. All rats
appeared normal at necropsy.
The acute oral LD50 for Fyrquel EHC (Trixylenyl Phosphate) given to female albino rats was >5000 mg/kg. Commonly observed adverse clinical signs included depressions piloerection, ataxia, evidence of excessive urination, and red-stained muzzles. All rats appeared normal at necropsy.
Executive summary:

The acute oral LD50 for male and female albino rats was > 5000 mg/kg body weight. Commonly observed adverse clinical signs included: Mild to moderate depression, piloerection, ataxia (female rats only), wet fur (male rats only), diarrhea (male rats only), yellowish anogenital stains (male rats only), evidence of excessive urination and red facial stains. All rats appeared normal at necropsy.

The substance is not classified on the basis of the results.