Fyroflex SOL-DP

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and appropriate guidelines

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

n/a

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

E-AF098T (Batch No. T# 176-3, Lot No. 474-0306-17), a white powder. Stored at room temp, dry, closed container

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Kuiper Rabbit Ranch (Gary, IN)
Age: Approximately 3-4 month old mail and female (females were nulliparous and non pregnant). Bodyweight: 2.77 to 3.32 kg the day after arrival.
Daily average animal room temperature and relative humidity: 71 ± 2oF and 34± 12%, respectively.
Identification- Earmark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

On the day of treatment, the neat test material was applied to the water-moistened clipped back of each rabbit and the test site covered with an
8-ply gauze dressing. The gauze dressing was secured with non-irritating porous tape. The entire mid-section of the rabbit was then wrapped with a lint-free cloth secured by an elastic adhesive bandage.
24 hr exposure, after which wrappings were removed and the application sites were wiped with water-moistened gauze.

Duration of exposure:

24 hours

Doses:

5000mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

The duration of observation period following administration was 14 days.
An initial dose group of 10 rabbits (5/sex) received a single dermal dose of the test material (5g/kg). Observation period: 14 days.
Moribundity/mortality, body weights and clinical signs were observed.

Mortality/viability -Twice daily
Body weights- Days 1 (pre-administration), 8 and 15
Clinical signs- At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. Time of onset, degree and duration were recorded and symptoms graded according to fixed scales.
Necropsy- The day following the 14-day observation period, all rabbits were euthanized by sodium pentobarbital overdose and subjected to a necropsy, which included examination of the external surfaces of the body, all orifices, and the following organs: brain, heart, lungs, spleen, liver, kidneys, gastrointestinal tract, urinary bladder and gonads. 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:

not relevant

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No death occured during the study.

Clinical signs:

No clinical signs of systemic toxicity or dermal irritation were observed in any of the animals during the study.

Body weight:

All rabbit gained weight during the study.

Gross pathology:

No treatment-related gross lesions were observed in any rabbit at necroscopy.

Other findings:

n/a

Any other information on results incl. tables

See attached files - tables and figures

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 is > 5000 mg/kg BW

Executive summary:

The acute dermal LD50 is > 5000 mg/kg BW