The notified polymer is slightly irritating to the eye. Eurofins (2010g) Irritation eye – Notified polymer variation 2 – OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals 3 males Observation Period 4 days Remarks - Method Prior to instillation of the test substance, two to three drops of ocular anaesthetic (tetracaine hydrochloride 0.5%) were placed into both eyes of each animal. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 1 1.7 1 2 < 4 days 0 Conjunctiva: redness 0.3 0.7 0.3 1 < 72 hours 0 Conjunctiva: chemosis 1 1 0.7 3 < 72 hours 0 Conjunctiva: discharge 0 0 0 1 < 24 hours 0 Corneal opacity 0 0.7 0.3 1 < 72 hours 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single application of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and moderate conjunctival irritation in all animals and corneal opacity in two animals. Two treated eyes appeared normal at the 72 hour observation with the remaining treated eye appearing normal at the 4 day observation. There were no deaths or test substance-related clinical signs or remarkable body weight changes during the study period. The notified polymer is slightly irritating to the eye. Eurofins (2010h) Skin sensitisation mouse local lymph node assay (LLNA) – Notified polymer variation 1 – OECD TG 429 Skin Sensitisation: Local Lymph Node Assay (2002 version) Species/Strain Mouse/CBA/JHsd (female) Vehicle N,N-dimethylformamide Remarks - Method An irritation screening study was not conducted and 100% was selected as the highest concentration based on the lack of severe irritant effects observed with the test substance. The main study was conducted using 5 mice/group at 0, 5, 25, 50 or 100% concentration. A concurrent positive control was conducted using 25% hexylcinnamaldehyde (HCA) in the vehicle (5 mice/group).
The notified polymer is slightly irritating to the eye. Eurofins (2010g) Irritation – eye Notified polymer – variation 2 OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals 3 males Observation Period 4 days Remarks - Method Prior to instillation of the test substance, two to three drops of ocular anaesthetic (tetracaine hydrochloride 0.5%) were placed into both eyes of each animal. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1 1.7 1 2 < 4 days 0 Conjunctiva: chemosis 0.3 0.7 0.3 1 < 72 hours 0 Conjunctiva: discharge 1 1 0.7 3 < 72 hours 0 Corneal opacity 0 0 0 1 < 24 hours 0 Iridial inflammation 0 0.7 0.3 1 < 72 hours 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single application of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and moderate conjunctival irritation in all animals and corneal opacity in two animals. Two treated eyes appeared normal at the 72 hour observation with the remaining treated eye appearing normal at the 4 day observation. There were no deaths or test substance-related clinical signs or remarkable body weight changes during the study period. The notified polymer is slightly irritating to the eye. Eurofins (2010h) Skin sensitisation – mouse local lymph node assay (LLNA) Notified polymer – variation 1 OECD TG 429 Skin Sensitisation: Local Lymph Node Assay (2002 version) Species/Strain Mouse/CBA/JHsd (female) Vehicle N,N-dimethylformamide Remarks - Method An irritation screening study was not conducted and 100% was selected as the highest concentration based on the lack of severe irritant effects observed with the test substance. The main study was conducted using 5 mice/group at 0, 5, 25, 50 or 100% concentration. A concurrent positive control was conducted using 25% hexylcinnamaldehyde (HCA) in the vehicle (5 mice/group).
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