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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:
3 March 1999 - 20 May 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)IGS BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Raleigh, NC
- Age at study initiation: 9-10 weeks (males), 10-11 weeks (females) old at initiation of dosing
- Weight at study initiation: 295-327g (males), 218 - 262g (females)
- Housing: individual suspended wire mesh cages
- Diet: PMI Nutrition International, Inc. Certified Rodent LabDiet 5002, ad libitum
- Water: reverse osmosis-treated municipal water, ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.05-22.3
- Humidity (%): 45-56.2%
- 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: clipped dorsal skin
- % coverage: 18-23
- Type of wrap if used: the application area was overwrapped with gauze binders that were secured with nonirritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application sites were wiped with disposable paper towels moistened with tepid water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test article was dosed undiluted based on its specific gravity. The dose volume was determined by dividing the dose level (2000mg/kg) by the specific gravity (1.05 g/ml). Individual doses were calculated based on body weights taken just prior to dosing and the dose volume of 1.90 ml/kg.


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5M/5F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were observed for overt signs of toxicity at 1, 3, and 4 hours, and once daily thereafter for a total of 14 days. Animals were observed twice daily for mortality. Body weights were recorded on days 0, 7, and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Examination of the cranial, thoracic, and abdominal cavities was carried out following termination.
  
Statistics:
No statistical analysis presented.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
Desquamation was noted sporadically during the study for five rats.
Body weight:
There were no remarkable body weight changes.
Gross pathology:
There were no remarkable gross necropsy findings.
Other findings:
There were no other test article related dermal findings.

Any other information on results incl. tables

The acute percutaneous LD50 of A-172 was determined to be  >2000 mg/kg, indicating a very low order of toxicity in the rat by this route.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute dermal LD50 value of >2000 mg/kg bw was determined for rats in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.