Screening procedures for eye irritation

Do safety data sheets (SDS) and chemical labels effectively communicate safety hazards and precautions? An initial appraisal report with special reference to reproductive toxicant chemicals used in biotechnology applications

“…Since the Hazard Statement H319 (Causes serious eye irritation) has been mentioned in the SDS of chloroform, acrylamide and dimethyl formamide (Table 2), these chemicals have to be categorized as Category 2A eye irritants. It has been argued that chemicals having a pH of ≤2.5 and pH ≥11.5 and those chemicals that exhibits a high toxicity through the dermal route (≤200 mg/kg lethality—i.e., Category 1 and 2 acute dermal toxicants) or a primary dermal irritation of ≥5 are severe eye irritants (i.e., Category 1 eye irritants—irreversible adverse effects on conjunctiva, cornea, and/or iris; these eye irritants exhibit adverse effects that will not get reversed within the observation period which is normally 21 days after exposure in at least one tested animal, and/or in at least two of three tested animals, a positive response of corneal opacity with a mean score of 3 or above, and/or a mean score of more than 1.5 for iritis, at 24 hours, 48 hours, and 72 hours), while the ability of a chemical to act as an eye irritant depends on other factors too such as concentration of the chemical, its ability to penetrate the corneal epithelium and the functional groups of that chemical (Hurley et al, 1993; Lusk, 1999). In this study, it can be concluded that the reviewed chemicals and chemical products are not Category 1 eye irritants since none of them are Category 1 or Category 2 acute dermal toxicants.• As per GHS, skin sensitizers can be sub-categorized into Category 1A (i.e., substances for which there is evidence from human studies that they can cause skin sensitization) and 1B (i.e., substances for which there is evidence from animal studies indicating that they can cause skin sensitization).…”

Do safety data sheets (SDS) and chemical labels effectively communicate safety hazards and precautions? An initial appraisal report with special reference to reproductive toxicant chemicals used in biotechnology applications

“…Since the Hazard Statement H319 (Causes serious eye irritation) has been mentioned in the SDS of chloroform, acrylamide and dimethyl formamide (Table 2), these chemicals have to be categorized as Category 2A eye irritants. It has been argued that chemicals having a pH of ≤2.5 and pH ≥11.5 and those chemicals that exhibits a high toxicity through the dermal route (≤200 mg/kg lethality—i.e., Category 1 and 2 acute dermal toxicants) or a primary dermal irritation of ≥5 are severe eye irritants (i.e., Category 1 eye irritants—irreversible adverse effects on conjunctiva, cornea, and/or iris; these eye irritants exhibit adverse effects that will not get reversed within the observation period which is normally 21 days after exposure in at least one tested animal, and/or in at least two of three tested animals, a positive response of corneal opacity with a mean score of 3 or above, and/or a mean score of more than 1.5 for iritis, at 24 hours, 48 hours, and 72 hours), while the ability of a chemical to act as an eye irritant depends on other factors too such as concentration of the chemical, its ability to penetrate the corneal epithelium and the functional groups of that chemical (Hurley et al, 1993; Lusk, 1999). In this study, it can be concluded that the reviewed chemicals and chemical products are not Category 1 eye irritants since none of them are Category 1 or Category 2 acute dermal toxicants.• As per GHS, skin sensitizers can be sub-categorized into Category 1A (i.e., substances for which there is evidence from human studies that they can cause skin sensitization) and 1B (i.e., substances for which there is evidence from animal studies indicating that they can cause skin sensitization).…”

Emergency Do Not Consume/Do Not Use concentrations for potassium permanganate in drinking water

“…62 –64 Consumption of 2 L of water at the Do Not Consume concentration is equivalent to 4 mg Mn/day or 36% of the 11 mg tolerable daily upper intake level. 179 As no quantitative ocular toxicity data were located, a Do Not Use level for KMnO 4 to prevent ocular injury could be based on pH; solutions with a pH less than 2.0 are considered corrosive in the eye 182 –184 and complaints of ocular irritation tend to increase as solution pH declines. 185 Even at KMnO 4 concentrations substantially higher (500 mg KMnO 4 /L or 174 mg Mn/L) than the limits derived here, the pH of KMnO 4 in distilled water (Table 2) is greater than that considered corrosive by regulatory agencies.…”

Soaps and Detergents: Alternatives to Animal Eye Irritation Tests

“…Hurley et al (1993), McCormick (1989, and the PMA (1990). Further testing, validation, and regulatory agency-industry discussions are ongoing, and it is hoped that results from various trials will help determine the testing schema of the near future.…”

Do safety data sheets (SDS) and chemical labels effectively communicate safety hazards and precautions? An initial appraisal report with special reference to reproductive toxicant chemicals used in biotechnology applications

“…Since the Hazard Statement H319 (Causes serious eye irritation) has been mentioned in the SDS of chloroform, acrylamide and dimethyl formamide (Table 2), these chemicals have to be categorized as Category 2A eye irritants. It has been argued that chemicals having a pH of ≤2.5 and pH ≥11.5 and those chemicals that exhibits a high toxicity through the dermal route (≤200 mg/kg lethality—i.e., Category 1 and 2 acute dermal toxicants) or a primary dermal irritation of ≥5 are severe eye irritants (i.e., Category 1 eye irritants—irreversible adverse effects on conjunctiva, cornea, and/or iris; these eye irritants exhibit adverse effects that will not get reversed within the observation period which is normally 21 days after exposure in at least one tested animal, and/or in at least two of three tested animals, a positive response of corneal opacity with a mean score of 3 or above, and/or a mean score of more than 1.5 for iritis, at 24 hours, 48 hours, and 72 hours), while the ability of a chemical to act as an eye irritant depends on other factors too such as concentration of the chemical, its ability to penetrate the corneal epithelium and the functional groups of that chemical (Hurley et al, 1993; Lusk, 1999). In this study, it can be concluded that the reviewed chemicals and chemical products are not Category 1 eye irritants since none of them are Category 1 or Category 2 acute dermal toxicants.• As per GHS, skin sensitizers can be sub-categorized into Category 1A (i.e., substances for which there is evidence from human studies that they can cause skin sensitization) and 1B (i.e., substances for which there is evidence from animal studies indicating that they can cause skin sensitization).…”

Emergency Do Not Consume/Do Not Use concentrations for potassium permanganate in drinking water

“…62 –64 Consumption of 2 L of water at the Do Not Consume concentration is equivalent to 4 mg Mn/day or 36% of the 11 mg tolerable daily upper intake level. 179 As no quantitative ocular toxicity data were located, a Do Not Use level for KMnO 4 to prevent ocular injury could be based on pH; solutions with a pH less than 2.0 are considered corrosive in the eye 182 –184 and complaints of ocular irritation tend to increase as solution pH declines. 185 Even at KMnO 4 concentrations substantially higher (500 mg KMnO 4 /L or 174 mg Mn/L) than the limits derived here, the pH of KMnO 4 in distilled water (Table 2) is greater than that considered corrosive by regulatory agencies.…”

Soaps and Detergents: Alternatives to Animal Eye Irritation Tests

“…Hurley et al (1993), McCormick (1989, and the PMA (1990). Further testing, validation, and regulatory agency-industry discussions are ongoing, and it is hoped that results from various trials will help determine the testing schema of the near future.…”

Do safety data sheets (SDS) and chemical labels effectively communicate safety hazards and precautions? An initial appraisal report with special reference to reproductive toxicant chemicals used in biotechnology applications

“…Since the Hazard Statement H319 (Causes serious eye irritation) has been mentioned in the SDS of chloroform, acrylamide and dimethyl formamide (Table 2), these chemicals have to be categorized as Category 2A eye irritants. It has been argued that chemicals having a pH of ≤2.5 and pH ≥11.5 and those chemicals that exhibits a high toxicity through the dermal route (≤200 mg/kg lethality—i.e., Category 1 and 2 acute dermal toxicants) or a primary dermal irritation of ≥5 are severe eye irritants (i.e., Category 1 eye irritants—irreversible adverse effects on conjunctiva, cornea, and/or iris; these eye irritants exhibit adverse effects that will not get reversed within the observation period which is normally 21 days after exposure in at least one tested animal, and/or in at least two of three tested animals, a positive response of corneal opacity with a mean score of 3 or above, and/or a mean score of more than 1.5 for iritis, at 24 hours, 48 hours, and 72 hours), while the ability of a chemical to act as an eye irritant depends on other factors too such as concentration of the chemical, its ability to penetrate the corneal epithelium and the functional groups of that chemical (Hurley et al, 1993; Lusk, 1999). In this study, it can be concluded that the reviewed chemicals and chemical products are not Category 1 eye irritants since none of them are Category 1 or Category 2 acute dermal toxicants.• As per GHS, skin sensitizers can be sub-categorized into Category 1A (i.e., substances for which there is evidence from human studies that they can cause skin sensitization) and 1B (i.e., substances for which there is evidence from animal studies indicating that they can cause skin sensitization).…”

Emergency Do Not Consume/Do Not Use concentrations for potassium permanganate in drinking water

“…62 –64 Consumption of 2 L of water at the Do Not Consume concentration is equivalent to 4 mg Mn/day or 36% of the 11 mg tolerable daily upper intake level. 179 As no quantitative ocular toxicity data were located, a Do Not Use level for KMnO 4 to prevent ocular injury could be based on pH; solutions with a pH less than 2.0 are considered corrosive in the eye 182 –184 and complaints of ocular irritation tend to increase as solution pH declines. 185 Even at KMnO 4 concentrations substantially higher (500 mg KMnO 4 /L or 174 mg Mn/L) than the limits derived here, the pH of KMnO 4 in distilled water (Table 2) is greater than that considered corrosive by regulatory agencies.…”

Soaps and Detergents: Alternatives to Animal Eye Irritation Tests

“…Hurley et al (1993), McCormick (1989, and the PMA (1990). Further testing, validation, and regulatory agency-industry discussions are ongoing, and it is hoped that results from various trials will help determine the testing schema of the near future.…”