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The nature and severity of the effect: The observed adverse effects in animals are regard as serious. The systemic health effects are the basis for the proposal of classification as repr. Cat. 3, R63. - dose-response relationship: There is no reason to assume a special concern The human population to which the information on exposure applies: following the exposure pattern there is no reason to assume a special risk for children, elderly, or pregnant women -other factors: There are no other factors known that might require a particular margin of safety. MOS for the inhalation exposure scenario, local effects Inhalation risk assessment will be based on the oral NOAEL of 42 mg cryolite/kg bw/day from the two-generation rat study. Taken forward to consumers (bodyweight 70 kg) and taking into acount oral (95%) and inhalation (90%) absorption this value corresponds to an air concentration for consumers of 3736 mg/m 3 (42 mg/kg bw/day x 0.95/0.9/0.83 m 3 ), assuming a respiratory volume of 0.83 for consumers in 1 hour shift. The air concentration resembles the corrected NOAEC. The margin of safety between the exposure level of 6.25 mg/m 3 and the inhalative NOAEC of 3736 mg/m 3 is judged to be sufficient. Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Summary of risk characterisation for consumers Concern is expressed and risk reduction measures should be intiated for consumer use in pottery. Inhalative repeated dose treatment of cryolite can induced fluorosis at relatively low doses. Regarding acute toxicity, skin irritation , sensitisation, mutagenicity, carcinogenicity and reproductive toxcicty no concern is expressed. Due to insufficient data base for eye irritation conclusion (i) on hold is appropriate. 34
3 Current Risk Reduction Measures Classification and labelling Classification of trisodium hexafluoroaluminate (Cryolite) according to Annex I of Directive 67/548/EEC (24 th ATP (98/73/EC), Index number: 009-016-00-2): T; R48/23/25 – Xn; R20/22 – N; R51-53. Trisodium hexafluoroaluminate (Cryolite) has to be labelled with T,N; R20/22-48/23/25-51/53; S(1/2-)22-37-45-61. The following proposal for a harmonised classification and labelling was laid down in an Annex XV –Dossier: Proposed classification based on Directive 67/548/EEC: T; R48/23/25 – Xn; R20 – Xi; R36 - Repr.Cat.3; R63. Abbreviations: T Toxic Xi Irritating Xn Harmful N Dangerous for the environment Repr. Cat. 3 Toxic for reproduction-Category 3 R20 Harmful by inhalation R20/22 Harmful by inhalation and if swallowed R48/23/25 Toxic: Danger of serious damage to health by prolonged exposure through inhalation and if swallowed R36 Irritating to eyes R51-53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment R63 Possible risks of harms to the unborn child S(1/2-) Keep locked up and out of the reach of children S22 Do not breathe dust S37 Wear suitable gloves S45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) S61 Avoid release to the environment. Refer to special instructions/Safety data sheets 35
Page 1 and 2: TRISODIUM HEXAFLUOROALUMINATE (Cryo
Page 3 and 4: CONTENT 0 SUMMARY 5 1 BACKGROUND 7
Page 5 and 6: 0 Summary Trisodium hexafluoroalumi
Page 7 and 8: 1 Background In the framework of EU
Page 9 and 10: By-production in aluminium smelters
Page 11 and 12: Company Location(s) Alcoa Aviles Sp
Page 13 and 14: Table 2.1: Occupational exposure le
Page 15 and 16: Comparison of MOS and reference MOS
Page 17 and 18: Repeated dose toxicity Local effect
Page 19 and 20: was established at 0.5 mg/m 3 (6h/d
Page 21 and 22: Combined exposure For all exposure
Page 23 and 24: Developmental toxicity Cryolite was
Page 25 and 26: Table 2.4 Developmental toxicity, p
Page 27 and 28: Tables 2.6 (inhalation) and 2.7 (de
Page 29 and 30: Table 2.7: Ranking of health risks
Page 31 and 32: Respiratory tract Regarding the sen
Page 33: and the analog sodium fluoride (NTP
Page 37 and 38: Country OEL (mg/m 3 STEL ) (mg/m 3
Page 39 and 40: 4 Possible Further Risk Reduction M
Page 41 and 42: Scenario 2: Use of cryolite in the
Page 43 and 44: Technical and organisational measur
Page 45: 6 Further Risk Reduction Measures R

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