Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21 DEC 2005 to 4 JAN 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study in accordance with OECD Procedure No. 402 (1987) and US EPA OPPTS 870.1200 (1998), and complying with principles of GLP (OECD and EPA).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Quality assurance statement for adherence to GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Lot No. 200-346
Specific gravity: 0.824 g/ml.
Physical state: Clear liquid soluble in corn and mineral oil.
Test substance was expected to be stable for the duration of testing

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA on December 6, 2005
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 295-307g (males) and 215-238g (females)
- Fasting period before study: No data
- Housing: Singly housed in suspended stainless steel caging with mesh floors. Litter paper placed beneath cage and changed at least 3 times per week.
- Diet: Purina Rodent Chow #5012
- Water: Filtered tap water ad libitum by automatic water dispensing system
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 21/12/2005 To: 22/12/2005

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The dorsal area and the trunk of animals was clipped (Oster model #A5-small) on the day prior to application. Test substance was applied evenly over a dose area of approximately 2 inches x 3 inches.
- % coverage: approximately 10% of the body surface
- Type of wrap if used: 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): pads removed and test sites gently cleansed
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.52 ml to 0.75 ml
- Concentration (if solution): Specific gravity - 0.823 g/ml (determined by testing laboratory)
- Constant volume or concentration used: constant concentration


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Selection of animals: After clipping and prior to application, the animals were examined for health, weighed (initial) and the skin checked for any abnormalities. Ten healthy rats (five males and five females) were selected for test.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours after application and at least once daily thereafter for 14 days. Individual body weights recorded prior to test substance application (initial) and again on Days 7 and 14 (termination).
- Necropsy of survivors performed: yes.
- Other examinations performed: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, and coma.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred
Clinical signs:
All animals survived, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation, adverse pharmacological effects, or abnormal behaviour.
Body weight:
Animals gained body weight during the study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Other findings:
No data.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance has no significant acute toxicity by the dermal route.
Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for a C24 -C56 hydrogenated polyalphaolefin to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 2000 mg/kg body weight in male and female rats. The study was conducted according to current OECD and EPA guidelines and is compliant with GLP standards. Based on the results of this study, this substance would not be classified for acute dermal toxicity in accordance with the current EU guidelines and the EU GHS classification regulation.