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
The No Observed Adverse Effect (NOAEL) was established as 150 and 30 mg/kg bw/day in male and female rats respectively in this study, based on effects on the liver. BASF Aktiengesellschaft (1996) 7.8. Genotoxicity – bacteria Analogue A OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 92/69/EEC B.14 Mutagenicity – Reverse Mutation Test Bacteria. Plate incorporation procedure/Pre incubation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, Metabolic Activation System S9 fraction from Aroclor 1254 induced rat Concentration Range in Main Test With and without metabolic activation: Test 1: 20, 100, 500, 2500, 5000 µg/plate Test 2 & 3: 15, 30, 60, 120, 250 µg/plate Vehicle DMSO Remarks – Method Three independent tests (2x plate incorporation and 1x pre-incubation) were conducted in triplicate. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 Not conducted ≥500 >5000 Negative Test 2 -- ≥250 (TA1535 only) >5000 Negative Test 3 -- ≥120 >5000 Negative Present Test 1 Not conducted ≥500 >5000 Negative Test 2 -- ≥250 (TA1535 only) >5000 Negative Test 3 -- ≥120 (all) & ≥250 (TA1537 only) >5000 Negative Remarks – Results No increases in the his+ revertant numbers were observed both in the incorporation and pre-incubation tests with any tester strains at any concentration either with or without S9 mix. A bacteriotoxic effect (reduced his- background growth and/or his+ revertant numbers) was observed at ≥120 – 250 µg/plate depending on the strains and test conditions. The vehicle and positive controls responded appropriately. The analogue chemical was not mutagenic to bacteria under the conditions of the test. BASF Aktiengesellschaft (1995a) 7.9. Genotoxicity – in vitro Remarks Test was not conducted. Analogue B chemicals have been negative in a variety of short-term genotoxicity tests (Talmage, 1994). 7.10. Genotoxicity – in vivo
100 20 0 0 LC50 37.3 mg/L (95%CI: 29.8-46.6) at 48 hours Remarks - Results The test concentrations remained stable with recovery >80% and thus nominal concentrations were presented without transformation. The notified polymer is considered to be harmful to daphnia. BASF Aktiengesellschaft (2001d) 8.2.3. Algal growth inhibition test Analogue polymer [Lutensol XL80 - details are claimed exempt from publication] OECD TG 201 Alga Growth Inhibition Test. EC Directive 92/69/EEC C.3 Algal Inhibition Test. US EPA OPPTS 850.5400 Alga Toxicity Test. Species Desmodesmus subspicatus CHODAT SAG 86.81 Exposure Period 96 hours Concentration Range Nominal 0.391, 0.781, 1.56, 3.13, 6.25, 12.5, 25, 50, 100 mg/L Auxiliary Solvent None Medium Deionised water Water Hardness Not reported Analytical Monitoring In vivo chlorophyll-a-fluorescence at 0, 24, 48, 72, and 96 h Remarks - Method Three replicates per each test concentration and five replicates for the control were used. The stability of the test substance was guaranteed by the sponsor and thus no concentration control analysis were performed. The pH and temperature remained within acceptable limits during the test. The EC50 values were determined by linear regression analysis of the concentration response relationship. Biomass Growth Nominal EbC50 Nominal Nominal ErC50 Nominal mg/L at 96 h mg/L at 72 h mg/L at 96 h mg/L at 72 h 23.2 6.25 40.2 6.25 Remarks - Results The test appears to meet the validity criteria. The analogue polymer is considered to be harmful to alga. BASF Aktiengesellschaft (2003b) 8.2.4. Inhibition of microbial activity Remarks Test was not conducted. 9. RISK ASSESSMENT 9.1. Environment 9.1.1. Environment – exposure assessment Potentially all of the notified polymer for industrial uses will be released into the when used cleaning water is released. The notified polymer is considered to be relatively soluble in water