Document e5qGvDk4yZLMJbGV6YDRaeRVy

TO: Interoffice Communication FROM: DATE: SUBJ: Distribution -tgg XF: --25----------------- T, G. Grumbles March 1, 1989 VISTA COMPARATIVE ETHER SULFATE EYE AND SKIN IRRITATION TESTING Eye and skin irritation testing was done to compare the relative irritation potential of Novel vs. "regular" 1214 GC-20, 1214 GC-30 and 1214 GC-40 Ether Sulfate. Attached is a comparative data table and the summary pages from the study reports. In general it appears the novel ether sulfates are more irritating to the eyes than the standard ether sulfates. However, with only one exception, Novel 1214 GC-20, the eye irritation scores are all in the "moderate" rating class. In other words although the scores differ, the irritation classification is the same. The exception, Novel 1214 GC-20 is classed as a severe irritant. This is an artifact of the classification scheme (attached) and is not significant. It was the result of one animal having a score of 31 when no animal can exceed a score of 30 to maintain the moderate classification. Also, it should be noted that the washed eyes exhibit a higher irritation than the unwashed eyes, which seems intuitively opposite of the expected result. However, the laboratory tells me this is not unexpected. The skin irritation results are variable, with Novel 1214 GC-20 and 40 being less irritating than the normal ether sulfates and Novel 1214 GC-30 being more irritating than normal ether sulfate. However, the score differences are within expected variability for acute dermal Irritation testing, and all results are within the moderate irritant category. T. G. Grumbles dlj .570 Distribution: O. C. Kerfoot-Ponca City (Full Study Copy) A. M. Nielsen-Ponca City (Full Study Copy) P. A. Morris-Ponca City W. L. McClain, M. Sweet VVV 000006900 TEST RESULTS Product Primary Dermal Irritation Novel 1214 GC-20 1214 GC-20 3.7 4.2 Novel 1214 GC-30 1214 GC-30 4.3 4.0 Novel 1214 GC-40 1214 GC-40 3.8 4.0 Primary Eye Irritation Washed________Nonwashed 38.7 20.0 25.8 15.7 25.3 19.0 19.0 24.8 34.2 15.0 45.7 28.3 vvv 000006901 5877-88 -6- I. SUMMARY An eye irritation study was conducted on nine albino rabbits using test material ALFONIC 1214GC-30 Ether Sulfate Sample No. V2769C, hereafter referred to as ALFONIC 1214GC-30 Ether Sulfate. Actual undiluted test material (0.1 ml) was placed into the conjunctival sac of the left eye of each animal selected for testing. The treated eyes of three of the animals were each washed with room temperature deionized water for 1 minute beginning 30 seconds after treatment. ALFONIC 1214GC-30 Ether Sulfate was rated as moderately irritating in nonwashed eyes and moderately irritating in washed eyes with maximum average irritation scores of 24.8 and 19.0, respectively. The test material is categorized as Toxicity Category I for nonwashed eyes and Toxicity Category II for washed eyes. Corneal opacity and/or invasion of the cornea by blood vessels was present in one nonwashed eye on Day 21. Corneal opacity and/or invasion of the cornea by blood vessels was not present in any washed eyes on Day 21. Project Director: A JairIcA 0. Kuhn, Ph.D. T&scifcologist ST1LLMEAD0W, Inc. Report Prepared By: Yvonne A. Pollard Data Services STILLMEADOW, Inc. STILLMEADOW, Inc. Technical Staff: Mark S. Holbert Carol M. Sempira Diane Hatton Vicki S. Crutchfield Scott J. Sabol Weston Anderson 5745-88 -6- I. SUMMARY A skin irritation study was conducted on six albino rabbits using test material NOVEL 1214GC-30 Ether Sulfate Sample No, V2717C, hereafter referred to as NOVEL 1214GC-30. There was one intact skin test site per animal. Each test site was treated with 0-5 ml of actual undiluted test material. The test sites were occluded for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48, and 72 hours and on Days 7, 10, 14, and 17 after the occlusion period. NOVEL 1214GC-30 produced a maximum irritation score of 4.3 and was given a descriptive rating of moderate irritant. Jaflijte 0. Kuhn, Ph.D. TTOoxxliccologist STILLMEADOW. Inc. Report Prepared By: Jane C. Coburn Data Services STILLMEADOW, Inc STILLMEADOW, Inc. Technical Staff: Carol M. Sempira Diane Hatton Vicki S. Crutchfield 000006^3 VW 5878-88 -6- I. SUMMARY A skin irritation study was conducted on six albino rabbits using test material ALFONIC 1214GC-30 Ether Sulfate Sample No. V2769C, hereafter referred to as ALFONIC 1214GC-30 Ether Sulfate. There was one intact skin test site per animal. Each test site was treated with 0.5 ml of actual undiluted test material. The test sites were occluded for 4 hours. Observations for dermal irritation and defects were made at l, 24, 48, and 72 hours and on Days 7, 10, 14, and 17 after the occlusion period. ALFONIC 1214GC-30 Ether Sulfate produced a maximum irritation score of 4.0 and was given a descriptive rating of moderate irritant. Project Director: STILLMEADOW, Inc. Report Prepared By: Yvonne A. Pollard Data Services STILLMEADOW, Inc. STILLMEADOW, Inc. Technical Staff: Carol M. Sempira Diane Hatton Asha Parikh Scott J. Sabol Weston Anderson WV 000006^04 5879-88 -13- Legend to Table 2 RABBIT EYE IRRITATION Rating of Test Material Based on Eye Irritation Ratine Maximum Averaee Score Definition Non-Irritating 0.0 - 0.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Practically Non-Irritating Greater than 0.5 - 2.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Minimally Irritating Greater than 2.5 - 15.0 To maintain this category, all scores at the 72-hour reading must be zero; otherwise, increase category one level. Mildly Irritating Greater than 15.0 - 25.0 To maintain this category, scores at the 7-day reading must be zero; otherwise, increase category one level. Moderately Irritating Greater than 25.0 - 50.0 To maintain this category, scores at the 7-day reading must be less than or equal to 10 for 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 20. If the 7-day mean score is less than or equal to 20, but less than 60% of the animals show scores less than 10, then no animal among those showing scores greater than 10 can exceed a score of 30 if category is to be maintained; otherwise, increase category one level. Severely Irritating Greater than 50.0 - 80.0 To maintain this category, scores at the 7-day reading must be less than or equal to 30 cor 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 40. If the 7-day mean score is less than or equal to 40, but less than 60% of the animals show scores less than or equal to 30, then no animal among those showing scores greater than 30 can exceed a score of 60 if category is to be maintained; otherwise, increase category one level. Extremely Irritating Greater than 80.0 - 110.0 NOTE: The category of the test material is not to be increased more than one level above its maximum average score. VW OOOOO^90^ 5879-88 -14- Legend to Table 2 (cont.) RABBIT EYE IRRITATION Criteria of Eye Irritation for Classification into Toxicity Categories Category I II Ill IV _______________________ Criteria Corrosive (irreversible destruction of ocular tissue) or corneal involvement or conjunctival irritation persisting through Day 21. Corneal involvement or conjunctival irritation clearing in 8 - 21 days. Corneal involvement or conjunctival irritation clearing in 7 days or less. Minimal effects clearing in less than 24 hours. 000006906 5747-88 -6- I. SUMMARY A skin irritation study was conducted on six albino rabbits using test material NOVEL 1214GC-40 Ether Sulfate Sample No. V2718C, hereafter referred to as NOVEL 1214GC-40. There was one intact skin test site per animal. Each test site was treated with 0.5 ml of actual undiluted test material. The test sites were occluded for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48, and 72 hours and on Days 7, 10, 14, 17, and 21 after the occlusion period. NOVEL 1214GC-40 produced a maximum irritation score of 3.8 and was given a descriptive rating of moderate irritant. The death of one animal on Day 9 of the study was not believed to be related to the administration of the test material. Project Director: STILLMEADOW, Inc. Report Prepared By: Jane C. Coburn Data Services STILLMEADOW, Inc. STILLMEADOW, Inc. Technical Staff: Carol M. Sempira Diane Hatton Vicki S. Crutchfield VVV 000006907 57^4-88 -6- I. SUMMARY An eye irritation study was conducted on nine albino rabbits using test material NOVEL 1214GC-30 Ether Sulfate Sample No. V2717C, hereafter referred to as NOVEL 1214GC-30. Actual undiluted test material (0.1 ml) was placed into the conjunctival sac of the left eye of each animal selected for testing. The treated eyes of three of the animals were each washed with room temperature deionized water for 1 minute beginning 30 seconds after treatment. NOVEL 1214GC-30 was rated as moderately irritating in nonwashed eyes and moderately irritating in washed eyes with maximum average irritation scores of 19.0 and 25.3, respectively. The test material is categorized as Toxicity Category I. Corneal opacity and/or invasion of the cornea by blood vessels was not present in any nonwashed eyes on Day 21. Corneal opacity and/or invasion of the cornea by blood vessels was present in one washed eye on Day 21. Project Director: Report Prepared By: Jane C. Coburn Data Services STILLMEADOW, Inc. STILLMEADOW, Inc. Technical Staff: Mark S. Holbert Carol M. Sempira Diane Hatton Vicki S. Crutchfield Scott J. Saboi VVV 000006908 i I } * Legend to Table 2 I RABBIT EYE IRRITATION j Rating of Test Material Based on Eye Irritation 5744-88 -13- ; Ratine Maximum Average Score Definition ' Mon-Irritating til 0.0 - 0.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Practically Non-Irritating Greater than 0.5 - 2.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Minimally Irritating Greater than 2.5- - 15.0 To maintain this category, all scores at the 72-hour reading must be zero; otherwise, increase category one level. Mildly Irritating Greater than 15.0 - 25.0 To maintain this category, scores at the 7-day reading must be zero; otherwise, increase category one level. Moderately Irritating Greater than 25.0 - 50.0 To maintain this category, scores at the 7-day reading must be less than or equal to 10 for 60? or more of the animals. Also, the 7-day mean score must be less than or equal to 20. If the 7-day mean score is less than or equal to 20, but less than 60% of the animals show scores less than 10, then no animal among those showing scores greater than 10 can exceed a score of 30 if category is to be maintained; otherwise, increase category one level. Severely Irritating Greater than 50.0 - 80.0 To maintain this category, scores at the 7-day reading must be less than or equal to 30 for 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 40. If the 7-day mean score is less than or equal to 40, but less than 60% of the animals show scores less than or equal to 30, then no animal among those showing scores greater than 30 can exceed a score of 60 if category is to be maintained; otherwise, increase category one level. Extremely Irritating Greater than 80.0 - 110.0 NOTE: The category of the test material is not ta be increased more than one level above its maximum average score. vvv 000006909 5744-88 -14- Legend to Table 2 (cont.) RABBIT EYE IRRITATION Criteria of Eye Irritation for Classification into Toxicity Categories Category I II III IV Criteria Corrosive (irreversible destruction of ocular tissue) or corneal involvement or conjunctival irritation persisting through Day 21. Corneal involvement or conjunctival irritation clearing in 8 - 21 days. Corneal involvement or conjunctival .irritation clearing in 7 days or less. Minimal effects clearing in less than 24 hours. VVV 000006910 5746-88 -13- Legend to Table 2 RABBIT EYS IRRITATION Rating of Test Material Based on Eye Irritation Ratine Maximum Average Score Definition Non-Irritating 0.0 - 0.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Practically Non-Irritating Greater than 0.5 - 2.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Minimally Irritating Mildly Irritating Greater than 2.5 - 15.0 Greater than 15.0 - 25.0 To maintain this category, all scores at the 72-hour reading must be zero; otherwise, increase category one level. To maintain this category, scores at the 7-day reading must be zero; otherwise, increase category one level. Moderately Irritating Greater than 25.0 - 50.0 To maintain this category, scores at the 7-day reading must be less than or equal to 10 for 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 20. If the 7-day mean score is less than or equal to 20, but less than 60% of the animals show scores less than 10, then no animal among those showing scores greater than 10 can exceed a score of 30 if category is to be maintained; otherwise, increase category one level. Severely Irritating Greater than 50.0 - 80.0 To maintain this category, scores at the 7-day reading must be less than or equal to 30 for 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 40. If the 7-day mean score is less than or equal to 40, but less than 60% of the animals show scores less than or equal to 30, then no animal among those showing scores greater than 30 can exceed a score of 60 if category is to be maintained; otherwise, increase category one level. Extremely Irritating Greater than 80.0 - 110.0 NOTE: The category of the test material is not to be increased more than one level above its maximum average score. VVV 000006911 5746-88 -14- Legend to Table 2 (cont.) RABBIT EYE IRRITATION Criteria of Eye Irritation for Classification into Toxicity Categories Category I II III IV Criteria Corrosive (irreversible destruction of ocular tissue) or corneal involvement or conjunctival irritation persisting through Day 21. Corneal involvement or conjunctival irritation clearing in 8 - 21 days. Corneal involvement or conjunctival irritation clearing in 7 days or less. Minimal effects clearing in less than 24 hours. VVV 000006912 4* * 5742-88 -13- Legend to Table 2 RABBIT EYE IRRITATION Rating of Test Material Based on Eye Irritation Ratine Maximum Average Score Definition Non-Irritating 0.0 - Q.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Practically Non-Irritating Greater than 0.5 - 2.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Minimally Irritating Greater than 2.5 - 15.0 To maintain this category, all scores at the 72-hour reading must be zero; otherwise, increase category one level. Mildly Irritating Greater than 15.0 - 25.0 To maintain this category, scores at the 7-day reading must be zero; otherwise, increase category one level. Moderately Irritating Greater than 25.0 - 50.0 To maintain this category, scores at the 7-day reading must be less than or equal to 10 for 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 20. If the 7-day mean score is less than or equal to 20, but less than 6Q% of the animals show scores less than 10, then no animal among those showing scores greater than 10 can exceed a score of 30 if category is to be maintained; otherwise, increase category one level. Severely Irritating Greater than 50.0 - 80.0 To maintain this category, scores at the 7-day reading must be less than or equal to 30 for 60% or more of the animals. Also, the 7-day mean score must be less than or equal to 40. If the 7-day mean score is less than or equal to 40, but less than 60% of the animals show scores less than or equal to 30, then no animal among those showing scores greater than 30 can exceed a score of 60 if category is to be maintained; otherwise, increase category one level. Extremely Irritating Greater than 80.0 - 110.0 NOTE: The category of the test material is not to be increased more than one level above its maximum average score. VVV 000006913 i 5742-88 -14- Legend to Table 2 (cont.) RABBIT EYE IRRITATION Criteria of Eye Irritation for Classification into Toxicity Categories Category I II Ill IV _______________________ Criteria Corrosive (irreversible destruction of ocular tissue) or corneal involvement or conjunctival irritation persisting through Day 21. Corneal involvement or conjunctival irritation clearing in 8 - 21 days. Corneal involvement or conjunctival irritation clearing in 7 days or less. Minimal effects clearing in less than 24 hours. VVV Q0Q006914 iSf-* i .. '?r,'%:' i ii 5875-88 -13- Legend to Table 2 RABBIT EYE IRRITATION Rating of Test Material Based on Eye Irritation Ratine Maximum Average Score Definition Non-Irritating 0.0 - 0.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Practically Non-Irritating Greater than 0.5 - 2.5 To maintain this category, all scores at the 24-hour reading must be zero; otherwise, increase category one level. Minimally Irritating Greater than 2.5 - 15.0 To maintain this category, all scores at the 72-hour reading must be zero; otherwise, increase category one level. Mildly Irritating Greater than 15.0 - 25.0 To maintain this category, scores at the 7-day reading must be zero; otherwise, increase category one level. Moderately Irritating Greater than 25.0 - 50.0 To maintain this category, scores at the 7-day reading must be less than or equal to 10 for 602 or more of the animals. Also, the 7-day mean score must be less than or equal to 20. If the 7-day mean score is less than or equal to 20, but less than 60% of the animals show scores less than 10, then no animal among those showing scores greater than 10 can exceed a score of 30 if category is to be maintained; otherwise, increase category .one level. Severely Irritating Greater than 50.0 - 80.0 To maintain this category, scores at the 7-day reading must be less than or equal to 30 for 60% or more of the animais. Also, the 7-day mean score must be less than or equal to 40. If the 7-day mean score is less than or equal to 40, but less than 60% of the animals show scores less than or equal to 30, then no animal among those showing scores greater than 30 can exceed a score of 60 if category is to be maintained; otherwise, increase category one level. Extremely Irritating Greater than 80.0 - 110.C NOTE: The category of the test material is not to be increased more than one level above its maximum average score. VVV 000006915 5875-88 -14- Legend to Table 2 (cont.) RAB3IT EYE IRRITATION Criteria of Eye Irritation for Classification into Toxicity Categories Category I II Ill IV _______________________ Criteria Corrosive (irreversible destruction of ocular tissue) or corneal involvement or conjunctival irritation persisting through Day 21. Corneal involvement or conjunctival irritation clearing in 8 - 21 days. Corneal involvement or conjunctival irritation clearing in 7 days or less. Minimal effects clearing in less than 24 hours. oooo6916