Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
One minor deviation that did not have any negative impacts on the results were described in the full study report and given in more detail below.
GLP compliance:
yes
Remarks:
GLP compliance statement is included in attached full study report
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Sample ID: CP-100
0.18% complex polymeric polyhydroxy acids (based on total organic carbon content of 0.1%)
Density: 0.9968 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Experimental Animals
Source: Texas Animal Specialties, Humble, TX
Date Born / Date Received: 2 Jun 2009 / 23 Jul 2009
Quarantine Period: 5 days
Quantity & Sex: 5 male and 5 females (nulliparous and non-pregnant)
Animal/Group Identification: Ear punch / Cage cards
Weights on Dosing Day: Male: 239-268 g ; Female: 175-191 g

Animal Husbandry
Cage Type: suspended, wire bottom, stainless steel
House: 1 per cage
Environmental Controls: set to maintain 22 °C (+/- 3 °C), 30-70% relative humidity, 12 hour light/dark cycle, 10-12 air changes/hour. Actual temp/humidity: 20-23 °C, 59-92% relative humidity
Food: PMI Feeds Inc. Formulab #5008, available ad libitum
Water: Municipal water supply analyzed by TCEQ Water Utilities Division; tap water, available ad libitum (automatic system)
Animal husbandry and housing at STILLMEADOW, Inc. comply with standards outlined in the “Guide for the Care and Use of Laboratory Animals” (NRC Publ.). No contaminants were expected to have been present in the feed or water that would have interfered with or affected the results of the study.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Healthy albino rats were released from quarantine. Each animal was prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. Care was taken to avoid abrading the skin. Only those animals with exposure areas free of pre-existing skin irritation or defects were used for this study. The test substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was covered with a 2 x 4 inch surgical gauze patch and secured with a non-irritating adhesive tape. The trunk of each animal was then wrapped with vet wrap that was secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance.
Duration of exposure:
After 24 hours, the wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible.
Doses:
All animals were treated with 5050 mg/kg (5.07 mL/kg) of undiluted test substance. An individual dose was calculated for each animal based on its Day 0 body weight just before exposure.
No. of animals per sex per dose:
5 males per dose. 5 females per dose.
Control animals:
no
Details on study design:
In-Life Observations
Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on days 7 and 14.

Dermal Irritation Observations
Observations for evidence of dermal irritation were made at approximately 60 minutes after removal of wrappings and on days 7 and 14.

Postmortem Observations
On Day 14 after dosing, each animal was euthanized by CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.

Results and discussion

Preliminary study:
All (male and female) normal at each observation.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 050 mg/kg bw
Based on:
test mat.
Mortality:
There was no morality during the study. The estimated acute dermal LD50, as indicated by the data, was determined to be greater than 5050 mg/kg body weight.
Clinical signs:
All animals appeared normal for the duration of the study. There were no signs of dermal irritation at any observation during the study.
Body weight:
Body weight gain was unaffected by the administration of the test substance, with the exception of one male and one female which lost weight during the second week.
Gross pathology:
The gross necropsy conducted at the termination of the study revealed no observable abnormalities.

Any other information on results incl. tables

Body weights, Time of Death, and Gross Necropsy


Dose Level: 5050 mg/kg (5.07 mL/kg)








































































































Animal #Dose (mL)Day 0 (g)Day 7 (g)Day 14 (g)Time of Death

Gross Necropsy Findings


21-M1.23242261334Day 14NOA
22-M1.36268302294Day 14NOA
23-M1.27251277312Day 14NOA
24-M1.21239266296Day 14NOA
25-M1.22240257295Day 14NOA
26-F0.917181187184Day 14NOA
27-F0.887175186200Day 14NOA
28-F0.968191217227Day 14NOA
29-F0.887175190213Day 14NOA
30-F0.952188217236Day 14NOA

NOA: No observable abnormalities.


 


 


Protocol Deviations:


 


1) Relative humidity was outside protocol range but did not affect study outcome

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The test substance was evaluated for its acute dermal toxicity potential and relative skin irritancy when administered to albino rats. The acute dermal LD50, as indicated by the data, is greater than 5050 mg/kg in males and females.