Registration Dossier

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-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:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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 (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 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