Observation period 72 hours Remarks Method 0.1 mL of test substance was instilled as a 10% w/w solution – into the right eyes of the test animals. Observations were taken at 24, 48 and 72 hours post-dosing. The Draize scoring system was used to grade the eye reaction observations. Results Lesion Mean score* Maximum Maximum Maximum value duration of value at end Animal No. any effect of observation period 1 2 3 4 5 6 Conjunctiva: 2 2 1 2 1.7 1.3 2 >72 hours 2 redness Conjunctiva: 1.7 0.7 1.7 1 1 1 2 >72 hours 1 chemosis Corneal 0 0 0 0 0 0 0 N/A 0 opacity Iridial 0 0 0 0 0 0 0 N/A 0 inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for each animal. Remarks - Results No corneal opacity or iritis were observed during the test period. At 24 hours after dosing, all treated eyes exhibited slight to mild hyperaemia, chemosis and ocular discharge. A slight increase in the severity of the irritation from 24 to 48 hours was observed, and although there was a slight decrease in irritation thereafter, irritation persisted in all rabbits through 72 hours. Conclusion ABIL Quat 3474 is slightly irritating to the eye under the conditions of the test. Test Facility Product Safety Labs (1995c) A.1.9 Skin Sensitisation GPMT – Test Substance ABIL Quat 3270 Method OECD TG 406 Skin Sensitisation GPMT – Species/Strain Guinea pig/Pirbright White Vehicle Water preliminary study Maximum Non-irritating Concentration: intradermal: 0.5% topical: 1% main study Number of Animals Test Group: 20 Control Group: 10 induction phase Induction Concentration: intradermal: 0.5% topical: 10% Signs of Irritation Not reported challenge phase Challenge Concentration: topical: 1%
Observation period 72 hours Remarks – Method 0.1 mL of test substance was instilled as a 10% w/w solution into the right eyes of the test animals. Observations were taken at 24, 48 and 72 hours post-dosing. The Draize scoring system was used to grade the eye reaction observations. Results Lesion Mean score* Animal No. Maximum value Maximum duration of any effect Maximum value at end of observation period 1 2 3 4 5 6 Conjunctiva: redness 2 2 1 2 1.7 1.3 2 >72 hours 2 Conjunctiva: chemosis 1.7 0.7 1.7 1 1 1 2 >72 hours 1 Corneal opacity 0 0 0 0 0 0 0 N/A 0 Iridial inflammation 0 0 0 0 0 0 0 N/A 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for each animal. Remarks - Results No corneal opacity or iritis were observed during the test period. At 24 hours after dosing, all treated eyes exhibited slight to mild hyperaemia, chemosis and ocular discharge. A slight increase in the severity of the irritation from 24 to 48 hours was observed, and although there was a slight decrease in irritation thereafter, irritation persisted in all rabbits through 72 hours. Conclusion ABIL Quat 3474 is slightly irritating to the eye under the conditions of the test. Test Facility Product Safety Labs (1995c) A.1.9 Skin Sensitisation – GPMT Test Substance ABIL Quat 3270 Method OECD TG 406 Skin Sensitisation – GPMT Species/Strain Guinea pig/Pirbright White Vehicle Water preliminary study Maximum Non-irritating Concentration: intradermal: 0.5% topical: 1% main study Number of Animals Test Group: 20 Control Group: 10 induction phase Induction Concentration: intradermal: 0.5% topical: 10% Signs of Irritation Not reported challenge phase Challenge Concentration: topical: 1%
Polysiloxanes-di-Me-NA103S_Final-SN-Report.docx