Remarks Test was not conducted. Analogue B chemicals have been shown to exhibit a low order of dermal toxicity (Talmage, 1994). 7.3. Acute toxicity inhalation – Remarks Test was not conducted. Inhalation exposure would be unlikely due to the expected low vapour pressure of the notified polymer, but could occur from mist or aerosols formed. Also, analogue B chemicals have been shown not to be acutely toxic to rats at concentrations less than or equal to their saturated vapour concentrations in air (Talmage, 1994). 7.4. Irritation skin – Notified polymer OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). US EPA OPPTS 870.2500 Acute Dermal Irritation. Species/Strain Rabbit/New Zealand White Number of Animals 1 male, 2 females Vehicle None applied undiluted as supplied – Observation Period 7 days Type of Dressing Semi-occlusive Remarks Method No significant protocol deviations. – Lesion Mean Score* Maximum Value Maximum Maximum at Animal No. Duration of Any End of Effect Observation Period 1 2 3 1.0 1.7 2.0 2 3 d 0 Erythema/Eschar 0.0 0.0 0.0 0 0 d 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks Results Slight to moderate erythema (grade 1-2) with scaling or severe scaling was – seen in all animals. The reactions resolved within 7 days after treatment except scaling was still observed in one animal at study termination. No oedema was noted. Primary irritation index (PII) = (Σ erythema at 1,24,48,72 hours)/(number of test sites x 4 scoring intervals) + (Σ oedema at 1,24,48,72 hours)/(number of test sites x 4 scoring intervals). PII = (5+5+4+5)/(3x4) = 1.6 (slightly irritating). The notified polymer is slightly irritating to the skin. BASF Aktiengesellschaft 7.5. Irritation eye – Notified polymer OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). US EPA OPPTS 870.2400 Acute Eye Irritation. Species/Strain Rabbit/New Zealand White
Remarks Test was not conducted. Analogue B chemicals have been shown to exhibit a low order of dermal toxicity (Talmage, 1994). 7.3. Acute toxicity – inhalation Remarks Test was not conducted. Inhalation exposure would be unlikely due to the expected low vapour pressure of the notified polymer, but could occur from mist or aerosols formed. Also, analogue B chemicals have been shown not to be acutely toxic to rats at concentrations less than or equal to their saturated vapour concentrations in air (Talmage, 1994). 7.4. Irritation – skin Notified polymer OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). US EPA OPPTS 870.2500 Acute Dermal Irritation. Species/Strain Rabbit/New Zealand White Number of Animals 1 male, 2 females Vehicle None – applied undiluted as supplied Observation Period 7 days Type of Dressing Semi-occlusive Remarks – Method No significant protocol deviations. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period 1 2 3 Erythema/Eschar 1.0 1.7 2.0 2 3 d 0 Oedema 0.0 0.0 0.0 0 0 d 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks – Results Slight to moderate erythema (grade 1-2) with scaling or severe scaling was seen in all animals. The reactions resolved within 7 days after treatment except scaling was still observed in one animal at study termination. No oedema was noted. Primary irritation index (PII) = (Σ erythema at 1,24,48,72 hours)/(number of test sites x 4 scoring intervals) + (Σ oedema at 1,24,48,72 hours)/(number of test sites x 4 scoring intervals). PII = (5+5+4+5)/(3x4) = 1.6 (slightly irritating). The notified polymer is slightly irritating to the skin. BASF Aktiengesellschaft 7.5. Irritation – eye Notified polymer OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). US EPA OPPTS 870.2400 Acute Eye Irritation. Species/Strain Rabbit/New Zealand White
STD1157FR.docx