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: OECD & GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Rabbits of both sexes were received from Myrtle's Rabbitry, Tennessee as adults. Animals were provided Purina rabbit chow #5322 ad libitum as was drinking water. Animals were quarantined for 5 days prior to study initiation. Male rabbits weighed 2.64 kg at study initiation while females weighed 2.95 kg. Rabbits were housed individually, and maintained in environment of 66-73 degrees F & 35-61% humidity. The photoperiod was 12 hr light/12 hr dark with 10 - 12 air changes per hours.

The in-life portion of the study was Jan 17 - 31, 1995.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The area of exposure was ~10% of body surface (dorsal surface of back). This area was calculated with the equation - Body surface area (cm2) = 9 x [body wt (grams)] exp 0.6667. The 10 % area was then delineated on a 4-ply porous gauze. The chemical was applied to this area of the gauze, moistened with equal volume of water (1 mL water per gram chemical), and applied to the backs of the test rabbits. The gauze was then covered with plastic wrap, and then an elastic wrap to secure the site. Upon completion of a 24 hr exposure period, the site was cleaned with gauze moistened with water.

The amount of solid test material applied to the skin site was equivalent to 2000 mg/kg.
Duration of exposure:
Exposure was 24 hr
Doses:
2000 mg/kg, single dose
No. of animals per sex per dose:
5 rabbits per sex
Control animals:
not required
Details on study design:
Rabbits were observed twice daily for mortality for a 14-day period. Each rabbit was weighed on Days 0, 7, & 14. Clinical signs were monitored once daily. All animals were necropsied at study termination. No other assessments were conducted.

Results and discussion

Preliminary study:
Because of negligible oral toxicity in rats, a limit test for dermal exposure was considered justified.
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10 rabbits
Clinical signs:
No behavioral or gross abnormalities were observed. There was an indication of edema (grade 1 in 9/10), and erythema (grade 1 in 10/10, grade 2 in 6/10 - transient 1-2 days).
Body weight:
Slight body weight loss was observed in 1/5 females during 7-14 day interval. Remaining rabbits progressively gained body weight during study.
Gross pathology:
No chemical related findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The dermal LD0 = 2000 mg/kg, and LD50 >2000 mg/kg
Executive summary:

The acute dermal toxicity of test chemical was assessed in rabbits of both sexes in a limit test per OECD & GLP guidelines. There were signs of dermal irritation at the application site, including edema and erythema. No chemical-related adverse clinical (behavioral or gross) effects were observed including mortality, body weight changes, or necropsy observations. The dermal LD0 = 2000 mg/kg, and LD50 >2000 mg/kg.