Solvent/vehicle: [if used] [Describe any solvent or carrier used in dose administration.] Duration of study: Other methods or conditions, if any: Observations: Cage-side observations for Clinical observations and body weights: [general condition, were made Body weights were appearance, demeanor, mortality and moribundity] [frequency]. measured [frequency]. Ocular observations: Test animals were observed for days following exposure. [frequency] [#] [Also give description and reference of irritation scoring method, including formula used for calculations]. Were raw data included? [Comment on the acceptability of the raw data provided.] Other observations, if any: RESULTS MORTALITY: [Indicate if mortality was observed.] OCULAR OBSERVATIONS: [Briefly describe irritation patterns if any, including the frequency, The eye irritation score was calculated as according to the duration, type of irritation and scores.] [#], scoring system, which classifies as [cite method] [formulation] [minimally, slightly, mild, moderately, irritating in severely, extremely] [species]. [Include a table if appropriate] For example: A summary of eye skin irritation scores used for the calculation of the highest mean eye irritation score (represented as the for all rabbits using the Kay and Calandra “Maximum Mean Total Score” (MMTS)) scoring system (Kay and Calandra 1962) is presented in Table 1. TABLE 1. Summary of Primary Eye Irritation Scores Mean Irritation Scores TOTAL Mean (# Incidences of positive effect/animal) Score Time Post Corneal Opacity Iritis Conjunctivitis Instillation 1 hour # (#/#) # (#/#) # (#/#) #* 24 hours 48 hours 72 hours * Represents the MMTS (Maximum Mean Total Score) or the time interval with the highest mean eye irritation score CLINICAL OBSERVATIONS: [in one or two sentences, state only the prominent clinical signs stressing those believed to be specific for the sample being tested. State the duration of the major clinical
Solvent/vehicle: [if used] [Describe any solvent or carrier used in dose administration.] Duration of study: Other methods or conditions, if any: Observations: Clinical observations and body weights: Cage-side observations for [general condition, appearance, demeanor, mortality and moribundity] were made [frequency]. Body weights were measured [frequency]. Ocular observations: Test animals were observed [frequency] for [#] days following exposure. [Also give description and reference of irritation scoring method, including formula used for calculations]. Were raw data included? [Comment on the acceptability of the raw data provided.] Other observations, if any: RESULTS MORTALITY: [Indicate if mortality was observed.] OCULAR OBSERVATIONS: [Briefly describe irritation patterns if any, including the frequency, duration, type of irritation and scores.] The eye irritation score was calculated as [#], according to the [cite method] scoring system, which classifies [formulation] as [minimally, slightly, mild, moderately, severely, extremely] irritating in [species]. [Include a table if appropriate] For example: A summary of eye skin irritation scores used for the calculation of the highest mean eye irritation score (represented as the “Maximum Mean Total Score” (MMTS)) for all rabbits using the Kay and Calandra scoring system (Kay and Calandra 1962) is presented in Table 1. TABLE 1. Summary of Primary Eye Irritation Scores Time Post Instillation Mean Irritation Scores (# Incidences of positive effect/animal) TOTAL Mean Score Corneal Opacity Iritis Conjunctivitis 1 hour # (#/#) # (#/#) # (#/#) #* 24 hours 48 hours 72 hours * Represents the MMTS (Maximum Mean Total Score) or the time interval with the highest mean eye irritation score CLINICAL OBSERVATIONS: [in one or two sentences, state only the prominent clinical signs stressing those believed to be specific for the sample being tested. State the duration of the major clinical