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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July-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 870.2500 (Acute Dermal Irritation)
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 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%)
Storage at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Experimental Animals
Source: Nichols Rabbitry Inc.; Lumberton, TX
Date Born / Date Received: 26 Apr 2009 / 15 Jul 2009
Quarantine Period: 5 days
Quantity & Sex: 2 male and 1 female (nulliparous and non-pregnant)
Animal/Group Identification: Ear punch / Cage cards
Initial Body Weights: Male: 3.000-3.450 kg ; Female: 3.250 kg
Final Body Weights: Male: 3.050-3.500 kg ; Female: 3.400 kg

Animal Husbandry
Cage Type: suspended, wire bottom, stainless steel
House: 1 per cage
Environmental Controls: set to maintain 20 °C (+/- 3 °C), 30-70% relative humidity, 12 hour light/dark cycle, 10-12 air changes/hour. Actual temp/humidity: 18-21 °C, 70-98% relative humidity
Food: PMI Feeds Inc. Lab Rabbit Diet #5321, 8 oz. daily
Water: Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water 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.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL of undiluted test substance
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after unwrap
Number of animals:
3 (2 male, 1 female)
Details on study design:
Test Substance Administration
Prior to starting the study, the pH of the test substance was determined to be 7.68. Each animal was prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or defects were selected for testing. A single intact exposure site was selected as the test site while the contralateral intact site served as a control site.
On Day 0, 0.5 mL of the undiluted test substance was applied to each test site and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) which was secured on both edges with strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test substance.

Removal of the Test Substance
After four hours, the patches and 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.

Observations
The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1, 24, 48, and 72 hours after unwrap.

Irritation Scoring Method
The scoring scale used to rate dermal irritation is presented below. For each animal, all of the erythema and edema scores through 72 hours were added, and the sum was divided by 4 to obtain an individual irritation score. The primary irritation index was determined by calculating the mean of the irritation scores for all the animals and was used to obtain a rating for the test substance. A Toxicity Category was assigned according to the scale presented below. The Toxicity Category is based on the erythema/edema observations at 72 hours only or the presence of necrosis at any time during the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
0003-F
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks:
No irritation observed (score 0) at 1, 24, 48, and 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
0002-X
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks:
No irritation observed (score 0) at 1, 24, 48, and 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
0001-M
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks:
No irritation observed (score 0) at 1, 24, 48, and 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
0003-F
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks:
No irritation observed (score 0) at 1, 24, 48, and 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
0002-X
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks:
No irritation observed (score 0) at 1, 24, 48, and 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
0001-M
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks:
No irritation observed (score 0) at 1, 24, 48, and 72 hr.
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See Table 1 in the uploaded full study report. All animals had erythema and edema scores of 0 at 1, 24, 48, and 72 hours after unwrap. Substance is non-irritating, toxicity category IV.
Other effects:
No other observed effects.

Any other information on results incl. tables

 


Protocol Deviations:


 


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


 

Applicant's summary and conclusion

Interpretation of results:
other: Category IV: non-irritating
Conclusions:
The primary irritation index of 0.0 out of possible 8.0 was obtained from theobservations at 1, 24, 48, and 72 hours, and was used to give Carbon Power a descriptive rating of non-irritating. Based on the 72-hour observations only, Carbon Power is assigned to Toxicity Category IV.