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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 870.2400 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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: 2.500-3.025 kg ; Female: 2.650 kg
Final Body Weights: Male: 2.525-3.075 kg ; Female: 2.675 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

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of undiluted test substance
Duration of treatment / exposure:
24 hours
Duration of post- treatment incubation (in vitro):
72 hours
Number of animals or in vitro replicates:
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. Healthy albino rabbits were released from quarantine. Both eyes of each animal were carefully examined within 24 hours prior to treatment with a fluorescein sodium ophthalmic solution and cobalt-filtered light. Both eyes of each animal were again carefully examined just prior to treatment, but without the fluorescein sodium ophthalmic solution. Only those animals without eye defects or irritation were selected for testing.
On Day 0, a dose of 0.1 mL of the undiluted test substance was placed into the conjunctival sac of the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were gently held together for one second to prevent loss of material. The untreated left eye served as comparative controls.

Observations
The treated eyes of all animals were examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures, and (if needed) an additional source of white light affixed to the examination table or using a handheld flashlight. The grades of ocular reaction were recorded at 1, 24, 48, and 72 hours after treatment. The corneas of all treated eyes were examined immediately after the 24-hour observation with a fluorescein sodium ophthalmic solution. A Finoff ocular transilluminator with cobalt blue filter (Welch Allyn, Skaneateles Fall, NY) was utilized to enhance visualization of fluorescein staining. Any of the corneas which exhibited fluorescein staining at the 24-hour observation were re-examined with the fluorescein sodium ophthalmic solution at each consecutive observation until fluorescein staining of the cornea no longer occurred. All treated eyes were washed with room temperature deionized water for 1 minute immediately after recording the 24-hour observation.

Irritation Scoring Method
Individual irritation scores for each animal at each scheduled observation were determined using the grading scale given in the attached study report. An average irritation score for each scheduled observation was determined, based on the number of animals tested. A maximum average irritation score was derived from the observation yielding the highest average irritation score. The maximum average irritation score was used to rate the test substance according to the rating presented in the attached study report. Any corneal involvement or iridic irritation with a score of 1 or more is considered positive. Any conjunctival irritation (redness or chemosis) with a score of 2 or more is considered positive.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
4063-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:
chemosis score
Basis:
animal #2
Remarks:
4058-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:
chemosis score
Basis:
animal #1
Remarks:
4056-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:
conjunctivae score
Basis:
animal #3
Remarks:
4063-F
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
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:
conjunctivae score
Basis:
animal #2
Remarks:
4058-M
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
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:
conjunctivae score
Basis:
animal #1
Remarks:
4056-M
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
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:
iris score
Basis:
animal #3
Remarks:
4063-F
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
10
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:
iris score
Basis:
animal #2
Remarks:
4058-M
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
10
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:
iris score
Basis:
animal #1
Remarks:
4056-M
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
10
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:
cornea opacity score
Basis:
animal #3
Remarks:
4063-F
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: No irritation observed (score 0) at 1, 24, 48, and 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
4058-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:
cornea opacity score
Basis:
animal #1
Remarks:
4056-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 parameter scores of 0 at 1, 24, 48, and 72 hours after treatment. Substance is non-irritating, toxicity category IV.
Other effects:
No other observed effects.

Any other information on results incl. tables

 


Protocol Deviations:


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:
Based on the maximum average irritation score of 0.0, the test substance Carbon Power is rated non-irritating. Since there were no positive effects during the study, the test substance is assigned to Toxicity Category IV.