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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:
2007-01-03 to 2007-01-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study with minor deviations (Housing and feeding conditions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Temperature of the animal room was outside of the protocol specific range
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 10 weeks
- Weight at study initiation: 330 - 388 grams for males and 206 - 221 grams for females
- Fasting period before study: no data
- Housing: Animals were housed 1 per cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Fresh PMI Rodent Chow (Diet #5012) was provided daily
- Water: Ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -22 °C
- Humidity (%): 18 - 72 %
- Photoperiod: 12 hour light/dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal area of the trunk
- coverage: 10 %
- Type of wrap if used: Impervious cuff and plastic-lined elastic bandage and secured with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Test sites were wiped with paper towels saturated with tap water and blotted dry with paper towels
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 0.41 to 0.44 cc for females, 0.66 to 0.78 cc for males
- Concentration: Undiluted
- Constant volume or concentration used: yes

Duration of exposure:
24 h
Doses:
2000 mg/ kg bw
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed 1,2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Animals were observed daily for dermal observations. Body weights were recorded immediately pretest, weekly and at termination
- Necropsy of survivors performed: All animals were examined for gross pathology. The contents of the abdominal and thoracic cavities were examined in situ for gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality. All animals survived the 2000 mg/kg bw dermal application.
Clinical signs:
Instances of chromorhinorrhea, chromodaeryorrhea and/or wetness of the anogenital area were observed in all animals during the study. These observations were most likely due to the fact that the animals wore Elizabethan-type collars and were therefore unable to groom themselves normally.
Seven animals were noted to have flaking skin during the observation period.
Body weight:
Body weight changes were normal.
Gross pathology:
Necropsy results were normal in 4/10 animals. Six animals were noted with scattered flaking of the treated skin area.

Applicant's summary and conclusion