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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 December 1994 - 28 December 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA
- Weight at study initiation: 235-265 g (males), 210-232 g (females)
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: Pelleted Purina Rodent Chow #5012
- Water: ad libitum (tap water)
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 22.2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 2x3"
- % coverage: 10% of the body surface
- Type of wrap if used: 2 1/4 x 3" adhesive backed-gauze patch, which was wrapped with 3" Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded just prior to test substance application (initial) and again on days 7 and 14 (termination). Cage-side observations were done at 1 and 24 hours after application and at least once daily thereafter for 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
One female animale exhibited alopecia.
Body weight:
No test article related findings were observed.
Gross pathology:
No findings for any examined tissues and/or organs were noted.
Other findings:
- Other observations: Dermal irritation was noted at the administration site of
all animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of testing, the single dose Acute Dermal Toxicity LD50 of the test substance is greater than 2000 mg/kg of bodyweight when applied as received.
Executive summary:

An Acute Dermal Toxicity test was conducted with rats to determine the potential for the test item to produce toxicity after topical application.Two thousand milligrams of the test substance per kilogram of bodyweight was applied to the skin of ten healthy rats for 24 hours.The animals were observed for signs of gross toxicity and mortality at least once daily for 14 days. Bodyweights were recorded just prior to application and again on days 7 and 14 (termination). Necropsies were performed on all animals al terminal sacrifice.

All animals survived and gained weight. One female exhibited alopecia from day 4 through 9. All other animals appeared active and healthy. Apart from the dermal irritation noted at the dose site of all animals, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Gross necropsy findings at terminal sacrifice were generally unremarkable.

Based on the results of testing, the single dose Acute Dermal Toxicity LD50 of the test substance is greater than 2000 mg/kg of bodyweight when applied as received.