Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 5 000 0/10 LD50 > 5 000 mg/kg bw Signs of Toxicity Four males and two females had a slight piloerection. Effects in Organs Two males had a slight mucosa enteritis. Remarks - Results None The notified chemical is of low toxicity via the oral route. Biolab SGS (1993a). 7.2. Acute toxicity - dermal No toxicity data were submitted. 7.3. Acute toxicity - inhalation No toxicity data were submitted. 7.4. Irritation skin – EUCAROL APG/SS Similar to EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand Number of Animals 3 Vehicle None. Observation Period 7 days. Type of Dressing Occlusive Remarks - Method No GLP or QA. Lesion Mean Score* Maximum Value Maximum Maximum Value at Animal No. Duration of Any End of Effect Observation Period 1 2 3 0 0 0 1 1 hour 0 Erythema/Eschar 0 0 0 0 - 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Primary irritating index (PII) = 0.25 The notified chemical is slightly irritating to skin. Biolab SGS (1993b). 7.5. Irritation - eye EUCAROL APG/SS Similar to EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 7 days Remarks - Method No GLP or QA. Discharge of conjunctiva was not observed.
Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 5 000 0/10 LD50 > 5 000 mg/kg bw Signs of Toxicity Four males and two females had a slight piloerection. Effects in Organs Two males had a slight mucosa enteritis. Remarks - Results None The notified chemical is of low toxicity via the oral route. Biolab SGS (1993a). 7.2. Acute toxicity - dermal No toxicity data were submitted. 7.3. Acute toxicity - inhalation No toxicity data were submitted. 7.4. Irritation – skin EUCAROL APG/SS Similar to EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand Number of Animals 3 Vehicle None. Observation Period 7 days. Type of Dressing Occlusive Remarks - Method No GLP or QA. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 1 1 hour 0 Oedema 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Primary irritating index (PII) = 0.25 The notified chemical is slightly irritating to skin. Biolab SGS (1993b). 7.5. Irritation - eye EUCAROL APG/SS Similar to EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 7 days Remarks - Method No GLP or QA. Discharge of conjunctiva was not observed.
STD1012FR.docx