natgillin/translations-raw huggingface dataset:
Den fundne mængde er dels angivet som resultat med DEHP som intern standard (3,7 µg), men her også over for sin egen standard, hvorved det korrekte resultat var 5,3 µg for den pågældende tandbørste.
The detected amount is partly stated as an analysis result against DEHP as internal standard (3.7 mg), but also against its own standard with the correct result of 5.3 mg for the relevant toothbrush.
Stoffet er kun fundet i en tandbørste (M-005), men selv om den relative mængde er lav i screeningen, er fundet bekræftet i en kvantitativ analyse.
The substance is observed in one toothbrush (M-005) but even if the relative amount is low in the screening the detection is confirmed in a quantitative analysis.
2-Phenoxyethanol, CAS nr. 122-99-6, klassificeret Xn;R22 Xi;R36, dvs. skadeligt ved indtagelse og øjenirriterende.
2-Phenoxyethanol, CAS no. 122-99-6, is classified Xn;R22 Xi;R36, i.e. harmful if swallowed and irritating to the eye.
Andre stoffer Af andre klassificerede stoffer er fundet:
Other substances The following other classified substances have been found:
Cyclohexanon, CAS nr. 108-94-1 er klassificeret Xn;R20, farlig ved indånding.
Cyclohexanone, CAS no. 108-94-1, is classified Xn;R20, Harmful by inhalation.
Stoffet er klassificeret sundhedsskadeligt, men indånding er næppe en aktuel eksponeringsvej for tandbørster.
The substance is classified as harmful by inhalation, but inhalation is hardly an actual route of exposure for toothbrushes.
4-Hydroxy-4-methyl-2-propanon, CAS nr. 123-42-2, klassificeret Xi;R36, dvs. øjenirriterende.
4-Hydroxy-4-methyl-2-propanon, CAS no. 123-42-2, is classified Xi;R36, i.e. irritating to eyes.
Stoffet er således lokalirriterende.
The substance is thus an irritant.
4.2 Udvælgelse af kemiske stoffer og tandbørster til kvantitativ analyse
4.2 Selection of chemical substances and toothbrushes for quantitative analysis
Der blev ved GC-MSscreeningen fundet 73 mere eller mindre identificerede kemiske forbindelser.
At the screening 73 more or less identified chemical compounds were identified.
Mange af de ikke identificerede stoffer er vurderet at være oligomere rester fra plastmaterialet eller overfladematerialet
It is our assessment that many of the unidentified substances are oligomer residues from the plastic material or the coating material.
Mange af stofferne er opløsningsmidler, som antages at hidrøre fra overfladepåføringer af trykfarver, dækmaterialer som lak osv.
Many of the substances are solvents, which presumably originate from the surface applications (coatings) of printing ink, finishing material like varnish etc.
Det understreges, at spørgsmålet om, hvorvidt de fundne stoffer udgør et reelt problem, først kan vurderes ved en kvantitativ analyse, som kan anvendes i vurdering af eksponeringen.
It should be emphasised that the question whether the detected substances constitute a real problem cannot be assessed until a quantitative analysis is carried out, and the results used at the assessment of the exposure.
Først når eksponeringen er kendt og kan sammenholdes med stoffets effekt, kan en risikovurdering udføres.
A risk assessment cannot be carried out until the exposure is known and can be compared with the effect of the substances.
Der blev herefter i samarbejde med Miljøstyrelsen udtaget 5 tandbørster til en kvantitativ analyse.
Consequently, in co-operation with the Danish Environmental Protection Agency, 5 toothbrushes were selected for quantitative analyses.
Udvælgelsen er baseret på de fundne stoffer og de fundne beskrivelser af effekter, der kan have betydning for brugerens anvendelse af tandbørsterne.
The selection is based on the detected substances and the available descriptions of effects, which might influence the consumer's use of the toothbrushes.
Til en mere detaljeret sundhedsvurdering og eksponeringsvurdering blev der i samarbejde med Miljøstyrelsen udvalgt en specifik kvantitativ analyse af migrerede mængder for følgende stoffer:
In co-operation with the Danish Environmental Protection Agency, a specific quantitative analysis of migrated amounts was selected for the following substances to perform a more detailed health and exposure assessment:
2-Butoxyethyl acetat 1-Methyl-2-pyrrolidinon Nikkel
2-Butoxyethyl acetate 1-Methyl-2-pyrrolidinone Nickel
Da disse stoffer er anset for de mest problematiske, skulle en vurdering af eventuelle sundhedsmæssige problemer ved eksponering af migrerede kemiske forbindelser med identificerede sundhedsskadelige effekter fra udvalgte tandbørster være dækket ind.
As these substances are considered to be the most problematic, an assessment of possible health problems at exposure of migrated chemical compounds with known harmful effects from the selected toothbrushes should be covered.
Baseret på de fundne stoffer er der foretaget en kvantitativ analyse af 5 tandbørster:
Based on the detected substances a quantitative analysis of 5 toothbrushes has been carried out:
Baseret på fundet af de uønskede phthalater.
Based on the detection of undesirable phthalates.
Naphthalen er kun fundet i denne tandbørste.
Naphthalene has only been detected in this toothbrush.
Methylpyrrolidon er fundet i den største mængde afgivet fra de screenede tandbørster.
Methylpyrrolidinone has been detected in the largest amount released from the screened toothbrushes.
Baseret på fundet af trimethylhexanol, 2-butoxyethanol og en ukendt phthalat.
Based on the detection of trimethylhexanol, 2-butoxyethanol and an unknown phthalate.
Baseret på fundet af carvon, methylbenzensulfonamider, 2-butoxyethanol (største værdi i screening), methylpyrrolidon.
Based on the detection of methyl-benzene sulphonamides, 2-butoxyethanol (highest value in the screening), and methylpyrrolidinone.
Baseret på fundet af N,N-dimethylacetamid, der var det mest sundhedsskadelige af de undersøgte stoffer samt tilstedeværelsen af carvon.
Based on the detection of N,N-dimethylacetamide, which was the most harmful of the examined substances, and the presence of carvone.
Baseret på fundet af tetrachlorethen, 2-butoxyethanol, butoxypropanol samt methylbenzensulfonamid (som her er fundet i store mængder).
Based on the detection of tetrachlorethene, 2-butoxyethanol, butoxypropanol and methyl-benzene sulphonamide (which was detected in large amounts).
Det var den tandbørste, der havde det største antal ”hits”, i alt 24 mere eller mindre identificerede kemiske forbindelser.
Furthermore, this toothbrush had the greatest number of “hits”; a total of 24 more or less identified chemical compounds.
På baggrund af de fremkomne oplysninger, og efter samråd med Miljøstyrelsen, er der udvalgt 12 stoffer til kvantitativ bestemmelse af migration til spyt fra 5 tandbørster vha. GC-MS.
Based on the obtained information, and having consulted the Danish Environmental Protection Agency, 12 substances have been selected for a quantitative determination in 5 toothbrushes by means of GC-MS.
Der er ligeledes udført kvantitativ bestemmelse af nikkel vha. ICP-MS.
Furthermore, a quantitative determination of Nickel by means of ICP-MS has been carried out.
5.1 GC-MS Analyse (kvantitativ bestemmelse) migration
5.1 GC-MS Analysis (quantitative determination) migration
5.1.1 GC-MS Analyse metodebeskrivelse
5.1.1 GC-MS Analysis method
Migrationen blev foretaget i simuleret spyt (DIN 53160-1) ved 37°C i 10 timer.
The migration was carried out in simulated saliva (DIN 53160-1) at 37°C for 10 hours.
Herefter blev analytterne i migrationsvæsken opkoncentreret på SPE rør og elueret i et organisk solvent.
After this, the analyts in the migration liquid were evaporated on SPE tubes and eluted in an organic solvent.
Efter inddampning blev eluenten analyseret ved GC-MS.
After evaporation the eluate was analysed by means of GC-MS.
Alle 10 tandbørster blev analyseret.
All of the 10 toothbrushes were analysed.
Ved hjælp af indkøbte standarder blev fundet af de udvalgte forbindelser bekræftet, og mængden af forbindelserne blev kvantificeret.
With the help of purchased standards the detection of the selected compounds was confirmed, and the amount of the compounds was quantified.
5.1.2 GC-MS Analyseresultater
5.1.2 GC-MS Analysis results
Analyseresultaterne er angivet i tabel 5.1 nedenfor for de 5 udvalgte tandbørster.
The analysis results are shown in Table 5.1 below for the 5 selected toothbrushes.
En detaljeret oversigt for alle 10 tandbørster er vist som bilag E.
A detailed survey of all 10 toothbrushes is shown in Encl. E.
Tabel 5.1 GC-MS analyseresultater, kvantitativ bestemmelse på 5 udvalgte tandbørster
Table 5.1 GC-MS analysis results, quantitative determination on 5 selected toothbrushes
µg/g tandbørste
µg/g toothbrush
N,N-dimethyl acetamid
µg/g toothbrush
5.2 ICP-MS Analyse (kvantitativ bestemmelse)
5.2 ICP-MS Analysis (quantitative determination)
5.2.1 ICP-MS Analyse metodebeskrivelse
5.2.1 ICP-MS Analysis method
Der er udført kvantitativ bestemmelse af nikkel i de 5 udvalgte tandbørster.
A quantitative determination of Nickel in 5 selected toothbrushes has been carried out.
Migrationen blev foretaget i simuleret spyt (DIN st, nr. 53 160-1) ved 37ºC i 10 timer.
The migration analysis was performed in simulated saliva (DIN st, no. 53 160-1) at 37°C for 10 hours.
Herefter blev nikkel bestemt direkte i ekstraktet, der blev gjort surt med salpetersyre (sub boiling), før analyse ved FI-ICP-MS med intern standardisering.
After this nickel was determined in the extract, which was made acid by means of nitric acid (sub boiling), prior to analysis by means of FI-ICP-MS with internal standardisation.
5.2.2 ICP-MS Analyse resultater
5.2.2 ICP-MS Analysis results
Resultatet af analysen er angivet nedenfor i tabel 5.2.
The result of the analysis is stated in below Table 5.2.
Mængderne er anført i µg pr. tandbørste.
The amounts are stated in µg per toothbrush.
Tabel 5.2 Resultatet af FI-ICP-MS analysen Prøvenavn
Table 5.2 Result of the FI-ICP-MS analysis
6.1 Vurdering af sundhedsrisikoen ved brug af tandbørster
6.1 Assessment of the health risk when using toothbrushes
Til vurdering af sundhedsrisikoen ved daglig brug af tandbørster vurderes de fundne stoffers effektværdier i forhold til den relevante eksponeringstid og eksponeringsvej.
In order to assess the health risk at daily use of toothbrushes the effect values of the detected chemical substances are assessed and compared with the relevant time of exposure and exposure pathway.
Eksponeringstiden for tandbørstning kan variere meget, men det mest almindelige for voksne er tandbørstning morgen og aften.
The time of exposure for toothbrushing might vary a lot, but the most usual practice for adults are toothbrushing in the morning and in the evening.
Hvis det antages, at gennemsnitstiden for hver børstning er 2 minutter, svarer det til en eksponeringstid på 4 minutter daglig.
If it is assumed that the average time for each toothbrushing is 2 minutes, this corresponds to a time of exposure of 4 minutes daily.
For børn er tandbørstning midt på dagen ikke ualmindeligt.
For children, it is not unusual to brush their teeth in the middle of the day.
Med samme eksponeringstid pr. gang svarer det til en daglig eksponering på 6 minutter.
With the same time of exposure at each event, this corresponds to a daily exposure of 6 minutes.
Af hensyn til realistisk ”worst case” anvendes oral optagelse for børn med en antaget legemsvægt på 10 kg. Optagelsen via mundhulen vil være stofspecifik og derfor afhængig af, hvilke stoffer der er fundet afgivet fra tandbørsterne.
In consideration of realistic “worst case”, oral absorption is used for children with an assumed body weight of 10 kg. The absorption through the oral cavity will be specific to each substance and thus dependent on the detected substance released from the toothbrushes.
Hvis der ikke har kunnet findes oplysninger om de enkelte stoffers specifikke optagelse over mundhule/slimhinder, er det antaget, at optagelsen er 100%.
If no information was found about the specific absorption through oral cavity/ mucous membranes of the individual substance, it is assumed that the absorption is 100%.
Da mindre børn kan finde på at sluge ”tandbørstningsproduktet” (opskummet tandpasta, vand og spyt samt dermed eventuelle stoffer afgivet fra tandbørsten), er det ikke anset for urealistisk.
As smaller children might swallow the “toothbrushing product” (i.e. foam from toothpaste, water, saliva and thus including potential substances released from the toothbrush), it is not considered to be unrealistic.
I undersøgelsen er 12 specifikke stoffer valgt til vurdering i samarbejde med Miljøstyrelsen.
In this examination, 12 specific substances were selected in co-operation with the Danish EPA for evaluation.
Udvælgelsen er baseret på stoffernes klassificering osv.
The selection was based on the classification of the substances, etc.
For hvert enkelt af de udvalgte stoffer er stoffet identificeret ved angivelse af det mest anvendte navn og CAS nr. for entydig identifikation.
Each of the selected substances has been identified by its common name and CAS no. for unambiguously identification.
Desuden er anført de mest almindelige synonymer.
Besides, the most common synonyms are stated.
Derefter er omtalt:
Furthermore is mentioned:
· Stoffets oprindelse og eventuelt hvad det bruges til for at vurdere, hvor i eller på tandbørsten kilden til stoffets tilstedeværelse potentielt kunne være.
· The origin and purpose of the substance in order to evaluate where in or on the toothbrush the potential source of the substance might be.
· Stoffets fysisk-kemiske data, som kan være relevante i vurderingen.
· The physical-chemical data of the substances, which may be relevant to the assessment.
· Stoffets klassifikation med eventuel angivelse af de koncentrationsniveauer, der kan medføre klassifikation af produktet.
· The classification of the substance with possible specification of the concentration levels which might result in classification of the product.
· Stoffets effekter på sundheden er opsummeret, dels akutte effekt niveauer, men også langtidsstudier, hvis de er tilgængelige.
· The effects of the substances on human health have been summarised, partly acute effect levels, but also long-term studies, if available.
· Stoffets grænseværdier gældende for arbejdsmiljø (de dækker koncentrationen i luften i arbejdsmiljø).
· The threshold limiting values (TLV) of the substance, valid for the working environment (they cover the concentration in air in the working environment).
De fundne værdier for tolerabel daglig indtag (TDI), acceptabel daglig indtag (ADI) eller referencedosis (RfD) anføres.
The available values for tolerable daily intake (TDI), acceptable daily intake (ADI) or reference dose (RfD) are mentioned (for explanation cf. the abbreviation list).
Hvis det er muligt, anvendes en af de etablerede værdier for tolerabel daglig indtag (TDI, ADI eller RfD er forklaret i forkortelseslisten) til vurdering af eksponeringen ved at sammenligne værdierne med de fundne analyseresultater estimeret til eksponeringen.
If possible, one of the established values for tolerable daily intake (TDI, ADI or RfD) is used for evaluation of the exposure by comparing the values with the obtained analysis results used to estimate the exposure.
Udgangspunktet er den maksimale fundne værdi, hvis de optræder i flere tandbørster.
The basis is the maximum found value, if they appear in several toothbrushes.
De anvendte usikkerhedsfaktorer vil være angivet i teksten.
The used uncertainty factors are mentioned in the text.
Findes der ikke en TDI, ADI, RfD værdi, foreslås en tolerabel koncentration baseret på et eller flere omtalte studier.
If there is no TDI, ADI, RfD value, a tolerable concentration based on one or more published studies is suggested.
Fremgangsmåden vil være omtalt for de enkelte stoffer.
The procedure is mentioned at the individual substances.
Ved oral eksponering sker absorption efter afgivelse (migration) af stofferne fra tandbørsten og opblandes i tandpasta, spyt, vand osv. Optagelse antages at kunne ske over væggen i mundhule eller mave-tarmkanalen.
At oral exposure absorption takes place after release (migration) of the substances from the toothbrush, after which they are mixed with toothpaste, saliva, water etc. Absorption is assumed to take place over the oral cavity mucous membrane or the gastrointestinal tract.
En yderligere eksponering kan tænkes via huden på håndfladen, der er i berøring med tandbørsten.
A further exposure may possibly take place via the skin of the palm being in contact with the toothbrush.
Eftersom afgivelserne er målt for hele tandbørstens overflade, anses dette at være inkluderet i vurderingen
Since the release is measured for the entire surface of the toothbrush, this is presumed to be included in the assessment.
Som udgangspunkt til vurdering af det orale indtag er der opstillet en generel ligning for indtagelse af stoffer (OECD 1993, EC 2003)
As a basis for assessment of the oral intake, a general equation has been set up for the ingestion of substances (OECD 1993, EC 2003):
Indtagelse af stoffet
Intake of the substance
Vægt af produkt der kommer i munden
Weight of product put in the mouth
g eller mg
g or mg
Koncentration af stoffet der er afgivet fra produktet pr. time
Concentration of the substance released from the product per hour
Antal gange pr. dag
Times per day
her antaget 1 gang/d
default assumed 1 time/day
Fraktion der absorberes (biotilgængelig del)
Fraction which is absorbed (bioavailable part)
Ligningen er herefter tillempet, så den passer til det foreliggende scenarie
After this the equation has been adjusted according to the present scenario
µg/tandbørste/10 (ekstraheret i 10 timer)
µg/ toothbrush/10 (as extracted for 10 hours)
minutter pr. time (60 minutter)
minutes per hour (60 minutes)
her antaget 3 gange/d
here assumed 3 times/day
Fraktion der absorberes (biotilgængelig del) BW Legemsvægt
Fraction which is absorbed (bioavailable part) BW Body weight
Oral indtagelse = (µg migreret/ 10 timer ´ 6/60 (minutter) ´ % absorption/100%)/10 (kg) = µg/kg legemsvægt pr. dag
Oral intake = µg released/10 hours ´ 6/60 (minutes) ´ % absorption/100%)/10 (kg) = µg/kg body weight per day
Analyseresultaterne angiver den migrerede mængde, der er fundet i spytekstraktioner efter 10 timers ekstraktion.
The analysis results state the migrated amount detected in the saliva extractions after 10 hours of extraction.
Mængden omregnes til afgivelse pr. time.
The amount is converted into release per hour.
Eksponeringstiden omregnes til en tidsmæssig fraktion pr. time (6/60 minutter).
The time of exposure is converted into a temporal fraction per hour (6/60 minutes).
Som udgangspunkt er valgt, at et barn børster tænder 3 gange daglig.
As a basis it is assumed that a child brushes its teeth 3 times daily.
Hver tandbørstning varer 2 minutter, dvs. en samlet eksponeringstid på 6 minutter daglig.
Each toothbrushing event lasts 2 minutes, i.e. a total time of exposure of 6 minutes daily.
Hvilket ville give en faktor på: 24/10 ´ 6/(60´24) =
This would result in a factor of 24/10 ´ 6/(60 ´ 24)
Legemsvægten er sat til 10 kg, hvilket svarer til et barn i 2-3 års alderen.
The body weight has been set at 10 kg, which corresponds to a child at the age of 2-3 years.
Efter eksponering af mundhulen skal det kemiske stof passere slimhinderne, før der kan tales om en egentlig absorption.
After exposure of the oral cavity the chemical substance must pass the mucous membranes, before being defined as a true absorption.
Der er kun fundet få data for dermal absorption af de undersøgte stoffer.
Only few data have been found for dermal absorption of the examined substances.
Den dermal absorption er derfor estimeret for mange af stofferne.
Consequently, the dermal absorption has been estimated for many of the substances.
Den dermale penetrering kan estimeres ud fra stoffets oktanol/vand fordelingskoefficient (log Kow) og molekylstørrelse.
The dermal penetration can be estimated from the substance octanol/water partition coefficient (log Kow) and the size of the molecule.
Kow, som er et udtryk for stoffets fordeling mellem oktanol og vand, antyder samtidig, om stoffet er lipophilt (høj Kow: foretrækker at være i fedtfasen) eller hydrophilt (lav Kow: foretrækker at være i vandfasen).
Kow, which is an expression of the substance partitioning between octanol and water, also indicates whether the substance is lipophilic (high Kow i.e. prefers lipid phase) or hydrophilic (low Kow i.e. prefers the water phase).
Dermal penetrering er anset for meget lille for stoffer med en log Kow mindre end -1, dvs. meget hydrophile (Vermeire et al. 1993).
Dermal penetration is considered to be very low for substances with a log Kow less than -1, i.e. very hydrophilic (Vermeire et al. 1993).
Potentialet for dermal penetrering stiger med Kow indtil en øvre grænse, hvorefter potentialet falder.
The potential for dermal penetration increases with Kow up to an upper limit above, which the potential is decreasing.
Den øvre grænse for Kow, hvor den dermale penetrering igen falder til ubetydelige niveauer, er ca. log Kow 5 (OECD 1993, EC 2003).
The upper limit for Kow above which the dermal penetration decreases again to insignificant levels, is approximately at log Kow 5 (OECD 1993, EC 2003).
Molekylvægten har indflydelse på den måde, at store molekyler har sværere ved penetrering end små molekyler.
The molecular weight influences the dermal penetration as larger molecules have more difficulties in penetrating the skin than smaller molecules.
Dermal penetrering er anset for meget lille for stoffer med en molekylvægt over 700 (Vermeire et al. 1993).
Dermal penetration is considered insignificant for substances having a molecular weight above 700 g/mol (Vermeire et al. 1993).
Ved standardvurderinger, eller hvor ingen oplysninger haves, anvendes typisk en dermal absorption på 100% (EC 2003).
At standard evaluations or in case no information is available, a dermal absorption of 100% (EC 2003) is typically used.
Det er gjort i alle tilfælde med de organiske stoffer, med mindre der er fundet oplysninger om absorptionen.
This has been done in all cases of organic substances, unless information about the absorption was found.
I så fald er disse anvendt som en forfining af estimaterne.
If so, these have been used as a refinement of the estimates.
Kortlægningen har haft til formål at vurdere, hvilke stoffer tandbørster afgav og i hvor store mængder.
The purpose of the survey has been to evaluate which substances were released from toothbrushes and in how large quantities.
6.2 Vurdering af enkeltstoffer
6.2 Evaluation of single substances
2-Butoxyethanol anvendes som opløsningsmiddel i overfladedæklag med sprøjtelak, hurtigtørrende lakker, emalje og latex maling (CICAD 1998).
2-Butoxy-ethanol is used as a solvent in surface coatings such as spray lacquers, quick dry lacquers, enamels and latex paint (CICAD 1998).
Fordelingskoefficienten log Kow er eksperimentelt bestemt til 0,83 (Hansch et al. 1995).
The partitioning coefficient log Kow has been experimentally determined to 0.83 (Hansch et al. 1995).
2-Butoxyethanol er klassificeret i Listen over farlige stoffer (Miljøministeriet 2002):
2-butoxy-ethanol is classified in the List of Dangerous Substances (Miljøministeriet 2002):
Farlig ved indånding, hudkontakt og ved indtagelse
Harmful by inhalation, in contact with skin and if swallowed
2-Butoxyethanol er moderat akuttoksisk, er irriterende for øjne og hud (men ikke sensibiliserende) (CICAD 1998).
2-Butoxy-ethanol is moderately acute toxic, irritating to eyes and skin (but not a skin sensitizer) (CICAD 1998).
Effekterne har mest været registreret som en haematolytisk aktivitet af butoxyethanol.
The effects have mostly been registered as a haematolytic activity of butoxyethanol.
Effekten var aldersafhængig med ældre rotter som de mest følsomme (CICAD 1998).
The effect was dependent on age with elder rats as the most sensitive (CICAD 1998).
Hudirritationen var mild ved 4 timers eksponering af kaninhud, men øgedes med stigende eksponeringstid (CICAD 1998).
The skin irritation was mild at 4 hoursof exposure of rabbit skin, but the irritation increased with increased time of exposure (CICAD 1998).