Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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); test exceeds the protocol recommended in the OECD Guidelines (1981)
Deviations:
no
Principles of method if other than guideline:
Stauffland albino rabbits were used in this study. A minimum of four male and four female rabbits had the test material applied to the closely clipped abdominal skin beneath a protective binder. The skin was abraded on half the animals and left intact on the others. After a 24 hour period, the binder material and test material were removed, the abdominal skin was inspected for irritation and rewrapped in a gauze binder. Three days later this gauze binder was removed. The test animals were observed for at least 14 days following the initial treatment. Necropsies were performed on all animals that died during the study and 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:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Animals used for this study were purchased from Phillips Rabbitry, Soquel, California.
Weight Range, kg: 1.550-2.038
No information on environmental conditions is provided.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A minimum of four male and four female rabbits had the test material applied to the closely clipped abdominal skin beneath a protective binder. The skin was abraded on half the animals and left intact on the others. After a 24 hour period, the binder material and test material were removed, the abdominal skin was inspected for irritation and rewrapped in a gauze binder. Three days later this gauze binder was removed.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
4
Control animals:
yes
Details on study design:
Stauffland albino rabbits were used in this study. A minimum of four male and four female rabbits had the test material applied to the closely clipped abdominal skin beneath a protective binder. The skin was abraded on half the animals and left intact on the others. After a 24 hour period, the binder material and test material were removed, the abdominal skin was inspected for irritation and rewrapped in a gauze binder. Three days later this gauze binder was removed. The test animals were observed for at least 14 days following the initial treatment. Necropsies were performed on all animals that died during the study and all survivors.
Statistics:
None reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Mortality: 0/10
Clinical signs:
The rabbits appeared normal throughout the test. Local dermal effects included mild erythema and edema following 24 hour exposure.
Body weight:
Not reported.
Gross pathology:
Ten rabbits were necropsied following termination on day 14 and appeared normal.

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
CLP criteria not met
Conclusions:
The acute dermal LD50 for Fyrquel EHC (Trixylenyl phosphate) given to a mixed population of albino rabbits was >2000 mg/kg. There were no apparent adverse clinical signs. Local dermal effects included mild erythema and edema following a 24 hour exposure. All rabbits appeared normal at necropsy
Executive summary:

The acute dermal LD50 for Fyrquel EHC (Trixylenyl phosphate) given to a mixed population of albino rabbits was >2000 mg/kg. There were no apparent adverse clinical signs. Local dermal effects included mild erythema and edema following a 24 hour exposure. All rabbits appeared normal at necropsy.

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