natgillin/translations-raw huggingface dataset:
Ifølge risikovurderingen af nikkel fra 2005 (Andersen, et al. 2005a - draft) er der ingen simpel sammenhæng mellem indhold af nikkel og frigivelse af nikkel (relateret til studier af mønter).
According to the risk assessment of nickel from 2005 (Andersen et al., 2005a - draft) there is no simple correlation between the content of nickel and the release of nickel (related to a study of coins).
Ligeledes nævner de, at når man skal vurdere risikoen for sensibilisering af nikkel, så er det koncentrationen af nikkelioner pr. cm² hud, der er interessant og ikke den totale nikkeldosis på huden.
Likewise they mention that when one is to evaluate the risk of sensitization due to nickel, it is the concentration of nickel ions per cm² skin that is interesting and not the total dose of nickel on the skin.
Kontaktdermatitis som følge af nikkelallergi er velkendt.
Contact dermatitis caused by nickel allergy is a well-known phenomenon.
Kontaktdermatitis blev fundet i 15,5% af 75.000 individer, som undergik en test med nikkelsulfat (Uter et al., 2003 i ATSDR, 2005a), hvilket indikerer, at det er en hyppig reaktion (ATSDR, 2005a).
Contact dermatitis was found in 15.5% of 75,000 individuals who participated in a test with nickel sulphate (Uter et al., 2003 in ATSDR, 2005a), which demonstrates that it is a common reaction (ATSDR, 2005a).
De fleste tilfælde af nikkelallergi skyldes hudkontakt med metalliske produkter som øreringe, smykker og knapper (European Environmental Contact Dermatitis Group, 1990 i Andersen et al., 2006).
The majority of the cases of nickel allergy is caused by skin contact with metallic products such as earrings, jewelleries and buttons (European Environmental Contact Dermatitis Group, 1990 in Andersen et al., 2006).
Et studie af skolebørn i alderen 7-12 år viste, at blandt børn med huller i ørerne havde 30,8% nikkelallergi, mens der blandt de børn, der ikke havde huller i ørerne, kun var 16.3% med nikkelallergi (Dotterud and Falk, 1994 i ATSDR, 2005a).
A study of school children in the age of 7-12 years showed that among children with pierced ears 30.8% had nickel allergy while among the children who did not have pierced ears only 16.3% were allergic to nickel (Dotterud and Falk, 1994 in ATSDR, 2005a).
De fleste nikkeltests laves med nikkelsulfat, fordi dette er mindre irriterende end nikkelchlorid.
The majority of nickel tests are made using nickel sulphate since this substance is less irritating than nickel chloride.
Menne and Calvin (1993) refereret fra ATSDR (2005a) undersøgte hudreaktioner over for forskellige nikkelchloridkoncentrationer hos 51 følsomme og 16 ikke-følsomme mennesker.
Menne and Calvin (1993) quoted from ATSDR (2005a) examined skin reactions related to different nickel chloride concentrations in 51 sensitive and 16 non-sensitive people.
Ved en koncentration på 0,01% sås ingen reaktion.
At a concentration of 0.01% no reaction was observed.
Ved 0,1% sås reaktioner hos 4 ud af de 51 personer.
At a concentration of 0.1% reactions in 4 out of the 51 people were observed.
Alt i alt konkluderes i EU-risikovurderingen af nikkel og nikkelforbindelser fra 2006 (Andersen et al, 2006), at der ikke er nok data tilgængelig vedrørende dermal eksponering af nikkelchlorid til at fastsætte hvilken dosis, der udløser en reaktion.
All in all it is concluded in the EU risk assessment of nickel and nickel compounds from 2006 (Andersen et al., 2006) that there is not enough data available regarding dermal exposure of nickel chloride to determine which dose that triggers a reaction.
I relation til akut nikkelforgiftning er nikkelcarbonyl, en flygtig væske af Ni(CO)4, den mest kritiske.
Regarding acute nickel poisoning nickel carbonyl, a fugitive fluid of Ni(CO)4, is the most critical.
Effekterne af akut nikkelcarbonylforgiftning inkluderer hovedpine, svimmelhed, kvalme, opkastning, søvnløshed og irritation fulgt af symptomer, som minder om lungebetændelse (WHO, 1991).
The effects of acute nickel carbonyl poisoning include headache, dizziness, nausea, vomiting, sleeplessness and irritation followed by symptoms which resemble pneumonia (WHO, 1991).
Et studie (Daldrup et al., 1983 i ATSDR, 2005a) har rapporteret et dødsfald hos et 2-årigt barn efter indtagelse af 570 mg Ni/kg (groft estimat) i form af nikkelsulfatkrystaller.
A study (Daldrup et al., 1983 in ATSDR, 2005a) has reported a death of a 2 year old child following ingestion of 570 mg Ni/kg (crude estimate) in the form of nickel sulphate crystals.
Fire timer efter indtagelse indtræf hjertesvigt, og barnet døde 8 timer efter indtagelsen.
Four hours after ingestion heart failure occurred and the child died 8 hours after ingestion.
Studier har indikeret, at opløselige nikkelforbindelser er mere toksiske end mindre-opløselige nikkelforbindelser.
Studies have indicated that soluble nickel compounds are more toxic than less-soluble nickel compounds.
Orale LD50værdier for nikkelsulfat på henholdsvis 46 mg Ni/kg (hunrotter) og 39 mg Ni/kg (hanrotter) er rapporteret (Mastromatteo, 1986 i ATSDR, 2005a).
Oral LD50values related to nickel sulphate of respectively 46 mg Ni/kg (female rats) and 39 mg Ni/kg (male rats) have been reported (Mastromatteo, 1986 in ATSDR, 2005a).
Ligeledes er orale LD50 værdier for nikkelacetat på henholdsvis 116 (hunrotter) og 136 mg Ni/kg (hanrotter) rapporteret (Haro et al., 1968 i ATSDR, 2005a).
Likewise, oral LD50 values related to nickel acetate of 116 (female rats) and 136 mg Ni/kg (male rats) respectively have been reported (Haro et al., 1968 in ATSDR, 2005a).
Orale LD50værdier for mindre-opløselige nikkeloxider og -subsulfider er rapporteret til at ligge omkring henholdsvis >3,930 og > 3,665 mg Ni/kg (Mastromatteo, 1986 i ATSDR, 2005a).
Oral LD50values for less-soluble nickel oxides and -subsulphides have been reported to >3.930 and > 3.665 mg Ni/kg respectively (Mastromatteo, 1986 in ATSDR, 2005a).
Denne værdi blev fundet for en hanrotte efter indtagelse af nikkelsulfat (Mastromatteo, 1986 i ATSDR, 2005a).
This value is derived from a study in which a male rat ingested nickel sulphate (Mastromatteo, 1986 in ATSDR, 2005a).
Den laveste værdi rapporteret i relation til systemiske effekter som følge af akut eksponering er en NOAEL værdi på 0,014 mg/kg/dag.
The lowest value reported in terms of systemic effects caused by acute exposure is a NOEAL value of 0.014 mg/kg/day.
Denne værdi er rapporteret i forbindelse med dermatitis hos nikkel-sensitive mennesker.
This value is reported in relation to dermatitis in nickel-sensitive humans.
Nikkel blev administreret i form af nikkelsulfat (ATSDR, 2005a).
Nickel was administered in the form of nickel sulphate (ATSDR, 2005a).
6.4.9 Længerevarende, gentagen påvirkning og genskadende effekter
6.4.9 Long-lasting, repeated effect and gene-damaging effects
Meget høje risici for lungekræft har desuden været rapporteret blandt arbejdere på nikkelraffinaderier.
Extremely high risk of lung cancer has furthermore been reported amongst workers in nickel refineries.
Arbejderne var udsat for nikkelsubsulfider, nikkeloxid og muligvis nikkelsulfat (WHO, 1991).
The workers were exposed to nickel subsulphides, nickel oxides and possible nickel sulphate (WHO, 1991).
De laveste NOAEL værdier rapporteret for mellemlang og lang eksponering af nikkel hos mennesker er ifølge ATSDR (2005a) 20 µg/kg/dag.
The lowest NOAEL value reported related to medium long and long exposure of nickel to humans is according to ATSDR (2005a) 20 µg/kg/day.
Denne værdi er rapporteret i forbindelse med et forsøg, hvor 8 nikkelfølsomme mennesker gradvist havde indtaget stigende doser af nikkelsulfat i drikkevand over 91-178 dage.
This value is reported in relation to a study in which 8 nickel sensitive humans gradually ingested increasing doses of nickel sulphate (in tap water) over a period of 91-178 days.
Ved den rapporterede værdi viste ingen individer sundhedsskadelige effekter på huden (Santucci et al., 1994 i ATSDR, 2005a).
At the reported value no individuals showed signs of health related effects on the skin (Santucci et al., 1994 in ATSDR, 2005a).
Nikkel blev tilført som nikkelsulfat.
Nickel was administered as nickel sulphate
Nikkel forbindelser er ifølge IARC (1997) kræftfremkaldende for mennesker, mens metallisk nikkel er muligvis kræftfremkaldende for mennesker.
Nickel compounds are according to IARC (1997) carcinogenic in humans, while metallic nickel is potential carcinogenic in humans.
Baars et al. (2001) kunne ikke finde nye relevante data vedrørende toksicitet som følge af oral eksponering af nikkel eller nikkelforbindelser hos mennesker eller dyr efter 1990.
Baars et al. (2001) was not able to find new relevant data (after 1990) regarding toxicity caused by oral exposure of nickel or nickel compounds in humans or animals.
De konkluderede derfor, at den TDI værdi på 50 µg/kg lgv/dag foreslået af Vermerie et al. (1991) (samt CEPA (1993), WHO (1996) og ATSDR (1997) i Baars et. al, 2001) stadig er gældende.
Thus, they concluded that the TDI value of 50 µg/kg bw/day suggested by Vermerie et al. (1991) (and CEPA (1993), WHO (1996) and ATSDR (1997) in Baars et al., 2001) still is valid.
Studiet, der ligger til grund for TDI'en på 50µg/kg lgv/dag, er et studie foretaget af Ambrose et al. i 1976.
The study from which the TDI value of 50 µg/kg bw/day was derived is a study performed by Ambrose et al. in 1976.
Dette studie fandt, som beskrevet ovenfor, en NOAEL værdi på 5000 µg Ni/kg lgv.
The study found, as described above, a NOAEL value of 5000 µg Ni/kg bw.
Forsøget var baseret på et 2-års studie af rotter, og effekterne undersøgt var nedsat kropsvægt og højere hjerte/krops vægt ratio.
The study included a 2-year study of rats and the effects observed were reduced bodyweight and higher heart/bodyweight ratio.
Et senere studie af American Biogenics Corp. (1988) fandt ligeledes en NOAEL værdi på 5000 µg/kg/dag.
A later study by American Biogenics Corp. (1988) likewise found a NOAEL value of 5000 µg/kg/day.
Miljøstyrelsens EU-risikovurdering af nikkel sulfat fra 2005 (Andersen et al., 2005b - draft) når frem til to NOAEL værdier til brug i risikovurderingen.
The EU risk assessment of nickel sulphate from 2005 (Andersen et al., 2005b - draft) arrives at two NOAEL values for use in risk assessment.
Den ene er en NOAEL værdi på 2200 µg/kg lgv/dag for oral administration af nikkel i et kronisk cancerforsøg.
One is a NOAEL value of 2200 µg/kg bw/day for oral administration of nickel - derived from a chronic cancer study.
Effekt ved højere eksponeringsniveau var nedsat overlevelse hos hunrotter og nedsat kropsvægt hos begge køn.
The effects at high exposure level were reduced survival in female rats and reduced bodyweight in both sexes.
Den anden NOAEL værdi er baseret på et to-generations studie af rotter (udsat for nikkelsulfat) og er relateret til effekter (øget perinatal dødelighed hos afkommet) under udviklingsprocessen.
The other NOAEL value is based on a two-generation study of rats (exposed to nickel sulphate) and is related to effects (increased perinatal mortality in the offspring) during the development process.
NOAEL værdien for moderdyrene var på 1100 µg Ni/kg lgv/dag.
The NOAEL value for the dam was 1100 µg Ni/kg bw/day.
For afkommet doseret efter den perinatale periode blev der identificeret et NOAEL på 2200 Ni/kg lgv/dag (Larsen og Tyle, 2008 - Draft), idet der ikke blev fundet effekter på afkommet.
Regarding the offspring (dosed after the perinatal period), a NOAEL value of 2200 µg Ni/kg bw/day was identified (Larsen and Tyle, 2008 - draft), since no effect was found in the offspring.
Baseret på ovenstående information antages en NOAEL værdi på 1100 µg/kg lgv/dag, for at være gældende i dette projekt.
Based on the above mentioned information a NOAEL value of 1100 µg/kg bw/day is assumed to be valid for use in this project.
6.4.10 Tolerabelt daglig indtag
6.4.10 Tolerable daily intake - TDI
Risikovurderingen af nikkelsulfat fra 2005 (Andersen et al., 2005b) opgiver en NOAEL værdi på 1100 µg/kg/dag relateret til fosterbeskadigende effekter.
The risk assessment of nickel sulphate from 2005 (Andersen et al., 2005b) gives a NOAEL value of 1100 µg/kg/day related to damaging effects on the foetus.
Til brug i dette projekt anvendes således en TDI værdi for nikkel på 4,4 µg/kg lgv/dag for kvinder.
For use in this project a TDI value related to nickel exposure (in women) of 4.4 µg/kg/day is used.
For børn har et supplement til EU-risikovurderingen fra 2008 vurderet, at det bedste grundlag til fastsættelse af en tilladelig dosis for børn er et NOAEL på 2200 µg/kg/dag baseret på en to-generationsundersøgelse og dosering af afkommet.
Regarding children a supplement to the EU risk assessment from 2008 has judged that the best basis for establishing a tolerable dose for children is a NOAEL value of 2200 µg/kg/day based on a two-generation study- and dosage of the offspring.
Ved anvendelse af en sikkerhedsfaktor på 100 opnås herved en TDI værdi på 22 µg/kg lgv/dag for børn (Larsen og Tyle, 2008 - Draft).
By using a safety factor of 100 a TDI value of 22 µg/kg/day for children is achieved (Larsen and Tyle, 2008 - draft).
Værdien for børn er derfor højere, dvs. de er mindre følsomme, end gravide kvinder, som er mere følsomme end børn.
The value related to children is thus higher which means that they are less sensitive than pregnant women.
Som for de andre metaller udsættes mennesker også for nikkel via andre kilder, såsom mad, vand og luft.
As for the other metals humans are also exposed to nickel via other sources such as food, water and air.
Det er derfor nødvendigt at tage hensyn baggrundseksponeringen, for at finde frem til den mængde af nikkel, som mennesker i Danmark kan tåle at få ”ekstra” per dag, uden at der opstår sundhedsskadelige effekter.
Thus, it is necessary to take into consideration the background exposure in order to identify the amount of nickel which humans in Denmark can tolerate to get “additionally” per day, without causing health related effects.
Baggrundseksponering af nikkel via føde og drikke i Danmark
Background exposure of nickel via food and beverages in Denmark
Ifølge rapporten fra Fødevarestyrelsen (Fromberg et al., 2005) er baggrundseksponeringen i relation til nikkel fra fødevarer i Danmark i gennemsnit 109 µg/dag, hvilket omregnet svarer til (109/60) 1,817 µg/kg lgv/dag.
According to a report from the Danish Veterinary and Food Administration (Fromberg et al., 2005) the background exposure of nickel from food in Denmark is in average 109 µg/day which corresponds to (109/60) 1.817 µg/kg bw/day.
Fromberg et al. (2005) opgiver ikke tal for nikkeleksponering fra føden hos 4-6 årige.
Fromberg et al. (2005) does not state a number related to children (4-6 years) regarding nickel exposure from food.
Imidlertid hævder Fromberg et al. (2005), at 2 årige børn (15 kg) indtager 59% af fødevarekonsumeringen hos voksne.
However, Fromberg et al. (2005) states that 2 year old children (15 kg) take in 59% of the amount of food which adults consume.
Fromberg et al. (2005) opgiver også baggrundseksponeringen i 95-percentiler (dvs. en værdi for hvad 95% af befolkningen maksimalt udsættes for).
Fromberg et al. (2005) also states a background exposure in terms of 95 percentiles (i.e. a value representing the maximum amount that 95% of the population is exposed to).
For at vælge en konservativ tilgang anvendes denne værdi til at estimere hvilken mængde nikkel et voksent menneske i Danmark antages at indtage via luften.
In order to choose a conservative approach this value is used to estimate the amount of nickel that an adult in Denmark inhales.
For børn (20 kg) gælder at de indtager (11 m³x5ng/m³/1000) 0,055 µg nikkel per dag, hvilket omregnet til per kilo legemsvægt giver et indtag af cadmium via luften på 0,003 µg/kg lgv/dag for børn.
Children (20 kg) inhale (11 m³x5ng/m³/1000) 0.055 µg nickel per day which corresponds to an intake of cadmium via the air of 0.003 µg/kg bw/day.
Da TDI værdien som tidligere nævnt repræsenterer den mængde stof som man maksimalt må få per dag (hele livet) uden at der opstår sundhedsskadelige effekter, fratrækkes TDI værdien de ovennævnte tal for baggrundseksponering.
As the TDI value, as mentioned earlier, represents the maximum amount of substance that a person can tolerate to take in per day (throughout his/her entire lifetime) without experiencing health related effects, the TDI value is subtracted the above mentioned figures representing background exposure.
Derved fås et tal for den ”ekstra tilførsel” af nikkel som et menneske må få dagligt (udover det de er eksponeret for via mad, drikke og luft) uden at der opstår sundhedsskadelige effekter.
Hereby a number is attained which represents the “extra addition” of nickel that humans can have on a daily basis (beside what they are exposed to via food, beverages and air) without causing health related effects.
Denne værdi sammenlignes i eksponeringsberegningerne med hvad mennesker udsættes for ved at bære eller sutte på de smykker, der er undersøgt i dette projekt.
In the exposure scenarios this value is then compared with the amount of nickel that humans are exposed to by wearing or sucking the jewellery examined in this project.
Dette betyder, at eventuelle tungmetaller/problematiske stoffer i smykker potentielt kan trænge ind i huden og medføre toksiske effekter.
This means that possible heavy metals/problematic substances in the jewelleries can penetrate the skin and induce toxic effects.
En anden eksponeringsvej kan opstå ved at sutte på smykkerne.
Another form of exposure can arise by sucking the jewelleries.
Nogle, sandsynligvis mest børn, har en tendens til at sutte på deres vedhæng på halskæden, hvorved de tungmetaller/problematiske stoffer, der migrerer fra smykket, direkte indtages.
Some people (probably mostly children) have a tendency to suck their pendants on the necklace and thereby absorb the migrating heavy metals/problematic substances directly.
Hertil kommer, at der, for børn såvel som voksne, kan være en risiko for, at små smykker ved uheld kan sluges.
Furthermore, there can be a risk for children, as well as for adults, that small jewelleries by accident can be swallowed.
Alvorligheden af dette bekræftes af et nyligt dødsfald af en 4-årig dreng.
The seriousness of this is confirmed by a recent death of a 4 year old boy.
Drengen havde ved et uheld slugt et hjerteformet smykke, som indeholdt over 99% bly.
The boy had by accident swallowed a heart-shaped jewellery containing more than 99% lead.
Episoden ledte til en frivillig tilbagekaldelse af 300.000 eksemplarer af det nævnte smykke (Berg et al., 2006).
The episode let to a voluntarily recall of 300,000 examples of the mentioned jewellery (Berg et al., 2006).
Ved migrationsanalyserne til kunstig sved findes den mængde tungmetal, der kan migrere til sved og derved potentielt optages via huden.
During the migration analysis the amount of heavy metal that can migrate to sweat and thereby potentially be absorbed via the skin is found.
Der er foretaget migrationstest for otte udvalgte tungmetaller i 25 forskellige delsmykker.
Migration tests for eight chosen heavy metals in 25 different jewellery parts have been performed.
Der viste sig dog kun at være 4 metaller (Cu, Pb, Ni og Cd), der migrerede i en koncentration over den målbare grænse.
Yet only 4 metals (Cu, Pb, Ni and Cd) showed to migrate in a concentration above the detection limit.
For disse 4 metaller er lavet en sundheds- og risikovurdering, hvori de TDI værdier, samt orale og dermale optagelsesrater for metallerne, der er udledt i kapitel 6 er benyttet.
For these 4 metals a health and risk assessment has been performed in which the TDI values plus the oral and dermal absorption rates for the metals deduced in chapter 6 are used.
Til brug i den følgende risikovurdering anvendes således følgende data:
For use in the following risk assessment the data below are applied:
Tabel 7-1: TDI værdier, samt dermal og oral optagelsesrater for de 4 metaller.
Table 7-1: TDI values plus dermal and oral absorption rates for the 4 metals.
7.1 Antagelser og usikkerheder forbundet med eksponeringsberegningerne
7.1 Assumptions and uncertainties related to the exposure calculations
7.1.1 To eksponeringstider - 16 og 24 timer
7.1.1 Two exposure periods - 16 and 24 hours
Under beregningerne af eksponering via huden antages det som worst case, at smykkerne har direkte kontakt med huden i al den tid, de bæres, dvs. at der eksempelvis ikke er et stykke tekstil i mellem smykke og hud.
During the calculations of exposure through the skin it is conservatively presumed that the jewelleries are in direct contact with the skin during all the time they are worn, e.g. there are for instance no textile between the jewellery and the skin.
Dvs. der opereres med to forskellige brugstider på henholdsvis 16 eller 24 timer afhængig af, om smykkerne tages af til natten eller ej.
Thus, two different periods of use are applied (16 and 24 hours respectively) depending on whether the jewelleries are removed during the night or not.
7.1.2 Migrationsanalyse for sved antages også at gælde for spyt
7.1.2 Migration analysis for sweat is presumed also to apply saliva
Migrationsanalysen foretages til kunstig sved, da det er den type eksponering, der hyppigst forekommer.
The migration analysis is performed to artificial sweat because this is the type of exposure that most frequently will occur.
Resultaterne fra migrationsanalysen til kunstig sved antages dog også at kunne anvendes til oral eksponeringsberegning, idet opløsningerne for kunstig sved og spyt ikke afviger væsentligt fra hinanden.
The results from the migration analysis to artificial sweat are also presumed to be able to be used in the oral exposure calculation because the solutions for artificial sweat and saliva do not deviate significantly from each other.
1,0 g urinstof (( N H 2)2 C O ), 5,0 g NaCl og 0,940 µl mælkesyre (C3H6O3) opløst i 1 liter demineraliseret vand.
1.0 g urea (( N H 2)2 C O ), 5.0 g NaCl and 0.940 µl lactic acid (C3H6O3) dissolved in 1 litre demineralised water.
Indstil pH til 6.5.
Set the pH to 6.5.
Ekstraktion/migration ved 40 grader.
Extraction/migration at 40 degrees.
Migrationsanalyse til spyt:
Migration analysis to saliva:
4,5 g NaCl + 0,3 g KCl + 0,3 g Na2SO4 +0,4 g NH4Cl + 3,0 g mælkesyre (C3H6O3) + 0,2 g urinstof (( N H 2)2 C O ) opløst i 1 liter demineraliseret vand, hvorefter pH indstilles til 5,0 med 2 N NaOH.
4.5 g NaCl + 0.3 g KCl + 0.3 g Na2SO4 + 0.4 g NH4Cl + 3.0 g lactic acid (C3H6O3) + 0.2 g urea (( N H 2)2 C O ) dissolved in 1 litre demineralised water. pH is set to 5.0 with 2 N NaOH.
Opløsningerne består begge primært af saltvand, hvilket betyder, at man kan forvente, at overfladespændingen er stort set ens.
The solutions consist both primarily of salt water which means that one can expect that the surface tension is approximately the same.
Samtidig er metaller positivt ladede i vandige opløsninger og vil derfor ikke kompleksbinde med natrium/kalium, hvorfor forskellen i koncentrationen af disse ingen betydning har.
Furthermore, metals are positively charged in aqueous solutions and therefore will not form complexes with sodium/potassium, thus the difference in concentration of these has no importance.
Temperaturen i begge opløsninger er stort set ens, og koncentrationen af chloridioner, som antages at være den komponent, der primært danner metalforbindelser, er også nogenlunde i samme størrelsesforhold.
The temperature in both solutions is approximately the same and the concentration of chloride ions, which is presumed to be the component that primarily forms metal compounds, is also in approximately the same dimensions.
Der er ca. 5 gange så meget urinstof i svedopløsningen i forhold til spytopløsningen, men da urinstoffet ikke forventes at danne komplekser med metallet, antages denne forskel ingen betydning at have.
There is approximately 5 times as much urea in the sweat solution as in the saliva solution, but because the urea is not expected to form complexes with the metal it is presumed that this difference is of no importance.