natgillin/translations-raw huggingface dataset:
Andre stoftyper, der har en hærdende effekt i produkterne, er dog ikke dækket af denne sundhedsvurdering.
Other kinds of substances with a hardening effect in the products are, however, not covered by his safety assessment.
Det kan ikke udelukkes, at de også kan have en skadelig virkning på brugerne.
It can not be excluded that they also may pose a risk for the users.
Ved brug af produktet anbefales det desuden, at anvendelse finder sted i vel ventilerede rum, hvilket formindsker eksponering via inhalation og derved risikoen for irritation af luftvejene.
During use of the product it is further recommend that it should take place in rooms with well airing minimising the exposure via inhalation and thereby the risk of irritation of the air ways.
Desuden skal brugerne være meget omhyggelige med at undgå hudkontakt, når neglehærderen påføres neglen.
Furthermore, the users should be very carefully when they apply nail hardeners at the nail plate to avoid skin contact.
7.2 Eksponering og risikovurdering af brugere af kunstige negle
7.2 Exposure and risk assessment for consumers using artificial nails
Sundhedsvurderingen af de udvalgte 4 akrylater viste, at deres kritiske effekt er deres allergi- og irritationsfremkaldende potentiale.
The safety assessment of the selected 4 acrylates showed that the critical effect of the substances is their potential to cause sensitisation or/and irritation.
Der blev fundet begrænsede data, der beskriver systemiske effekter.
Limited data was found describing systemic effects.
Stoffer i kunstige negle kan absorberes gennem huden, der omgiver neglen, når/hvis materialet kommer i kontakt med huden.
Substances in artificial nails may be absorbed through the skin surrounding the nail when/if the material is in contact with the skin.
Nogle af stofferne i produktet er flygtige ved stue- og hudtemperatur og kan indåndes efter fordampning fra neglen og områder på huden.
Some of the substances in the products are volatile at room- and skin temperature and may be inhaled after evaporation from the nail and areas of the skin.
Det kan derfor være relevant også at medtage inhalation i risikovurderingen.
Therefore, it may be relevant to include calculation of inhalation in the dose estimation.
Under denne proces kan brugeren blive eksponeret for fint støv fra neglen indeholdende forskellige kemikalier.
By that procedure, fine dust from the nail may expose the user further for different chemicals.
Denne eksponering er ikke medtaget i scenarierne, da den vurderes hovedsagligt at være af betydning for negleteknikeren, der ikke er omfattet af dette projekt.
This exposure is not included in the scenarios as it is evaluated to be most important for the safety of the nail technician, which is not included in the project.
Brugeren kan også bide eller sutte på fingrene og kan derved eksponeres oralt for stoffer i de kunstige negle.
The user may also bite or suck their fingers and thereby expose them self via the oral route.
I denne risikovurdering er der imidlertid valgt at fokusere på den dermale eksponering, da denne eksponering vurderes at bidrage væsentlig til mulige risici i forbindelse med brugen.
However, in this risk assessment the focus was the dermal exposure as this exposure route is evaluated to constitute the largest contribution to possible risks for the users.
Eksponering for stofferne i kunstige negle afhænger af de typer neglesystemer, der anvendes.
The exposure of the substances in artificial nails depends on which system is used.
Modelpersonen bruger to forskellige kunstige neglesystemer; kunstige akrylnegle (liquid and powder) eller gelénegle.
The model person uses two different artificial nail systems; acrylic artificial nails (liquid and powder) or gel nails.
7.2.1 Risikovurdering af systemiske effekter - kunstige akrylnegle
7.2.1 Risk assessment for systemic effects - artificial acrylic nails
2-Hydroxyethylakrylat, 2 hydroxypropylmethakrylat og ethylendimethakrylat blev fundet i kunstige akrylnegleprodukter.
2-Hydroxyethyl acrylate, 2-hydroxypropyl methacrylate and ethylene dimethacrylate were found in artificial acrylic nails products.
Derfor forudsættes det, at 9 % af det anvendte negleprodukt vil dække huden, der omgiver neglen og derved bidrage til den systemiske dosis.
Therefore, it is assumed that 9% of the applied nail product will cover the skin surrounding the nail, and thereby may contribute to the systemic dose.
Følgende forudsætninger blev anvendt som et realistisk worst-case scenarie:
The following assumptions were used as realistic worst-case scenario:
Vægt, voksen person:
Weight of person, adult:
Anvendt mængde pr. applikation (væske)
Applied amount per application (liquid):
Indhold i produkt:
Content in product (maximum):
15 % ≈ 150 g/kg produkt
15% ≈ 150 g/kg product
Det forudsættes desuden, at en ubetydelig mængde produkt trænger igennem neglen.
It is further assumed that a negligible amount of acrylate penetrate the nail.
1 gang pr dag x 0,002 kg væske x 9 % x 150 g/kg produkt 40 kg
1 time pr day x 0.002 kg liquid x 9% x 150 g/kg product 40 kg
NOAELS for systemiske effekter blev kun fundet for 2 af de 3 akrylater (tabel 7.2).
NOAELS for systemic effects were only found for 2 of the 3 acrylates (table 7.2).
Maksimal mængde i produkt (%)
Maximum amount in product (%)
2-Hydroxyethylakrylat 2-Hydroxypropylmethakrylat Ethylendimethakrylat
2-Hydroxyethyl acrylate 2-Hydroxypropyl methacrylate Ethylene dimethacrylate
På basis af dette scenario og de NOAEL's, der blev fundet for akrylaterne ses det tydeligt, at stofferne ikke vil udgøre en sundhedsrisiko for brugerne af kunstige akrylnegle i forhold til systemiske effekter.
Based on this scenario and the NOAELS found for the acrylates it clearly shows that the substances will pose no health risk for the users of artificial acrylic nails concerning systemic effects.
Der blev ikke identificeret NOAEL for ethylendimethakrylat.
For ethylene dimethacrylate no NOAEL was identified.
Med den beregnede eksponering vurderes det, at risikoen for systemiske effekter er ubetydelig.
However, with the calculated exposure, it is evaluated that the risk of systemic effects is negligible.
Anvendt mængde pr. applikation:
Applied amount per application (gel)
Indhold i produkt (Gelé):
Content in product (Gel):
Med hensyn til det kunstige akrylneglesystem forudsættes det, at 9 % af det anvendte negleprodukt vil dække huden, der omgiver neglen og derved kan bidrage til den systemiske dosis.
As for the artificial acrylic nail system it is assumed that 9% of the applied nail product will cover the skin surrounding the nail, and thereby may contribute to the systemic dose.
Daglig eksponeringdermal, 2-hydroxyethylakrylat:
Daily exposuredermal, 2-hydroxyethyl acrylate:
1 gang pr dag x 0,003 kg gel x 9 % x 82,5 g/kg produkt 40 kg
1 time pr day x 0.003 kg gel x 9% x 82.5 g/kg product 40 kg
= 0,56 mg/kg lgv/dag
= 0.56 mg/kgbw/day
I lighed med akrylneglesystemet vil geléneglene i forhold til stoffernes systemiske effekter ikke udgøre nogen sundhedsrisiko for brugerne.
As for the acrylic nail system, the gel nails pose no health risks for the users concerning systemic effects of the substances.
7.2.3 Risikovurdering af sensibilisering - kunstige negle
7.2.3 Risk assessment for sensitisation - artificial nails
Denne kortlægning af kunstige negle har vist, at produkterne indeholder et bredt spekter af stoffer; f.eks. forskellige akrylater (kapitel 4).
This survey of artificial nails has shown that the products contain a large range of substances; ex. different acrylates (chapter 4).
En omfattende risikovurdering af produkterne er derfor vanskelig at gennemføre, fordi alle ingredienser ikke er kendt.
Thus, a comprehensive risk assessment of the products is difficult to perform as not all the ingredients are known.
Yderligere viser litteraturen, at mange akrylater kryds-reagerer med andre akrylater og således gør sikkerhedsvurderingen mere kompleks (21,32).
Furthermore, literature shows that many acrylates cross-react with other acrylates making the safety assessment more complex (21,32).
Litteraturen viser, at allergiske hudreaktioner er et sundhedsproblem for brugerne at kunstrige negle (20,21,33,34,35).
Literature shows that sensitisation is a health problem for the users of artificial nails (20,21,33,34,35).
Data fra litteraturen er baseret på humane lappetests på personer med hudproblemer eller allerede har allergier og ikke tests på induktion af allergiske reaktioner hos sunde personer.
The data from the literature is based on human patch tests performed with already sensitised persons, and not test of the induction of allergic reaction in healthy persons.
Litteraturen viser, at allergiske læsioner fremkommet efter brug af kunstige negle ofte opstår rundt om neglene men også ses spredt til ansigt og øjenlåg (31).
The literature shows that the allergic lesions due to artificial nails are classically around the nails, but are also seen spread to the face and eyelids (31).
Allergiske reaktioner kan forekomme i 2 til 4 måneder, og endog 16 måneder efter påsætning af den kunstige negl.
Allergic reactions may occur 2 to 4 months, and even as long as 16 months after the application.
Den første indikation er kløe i negleroden.
The first indication is an itch in the nail bed.
Paronychia, som normalt forekommer i allergiske reaktioner, er forbundet med ulidelige smerter i negleområdet og somme tider med en sovende fornemmelse i negleområdet (paresthesia).
Paronychia, which is usually present in allergic reactions, is associated with excruciating pain in the nail area, and sometimes with paresthesia.
Den naturlige negl bliver tyndere, den knækker og bliver undertiden misfarvet.
The natural nail plate becomes thinner, split and sometimes discoloured.
Det tager adskillige måneder for neglen at vende tilbage til normalt udseende.
It takes several months for the nail to return to normal.
Permanent tab af neglene forekommer sjældent (30).
Permanent nail loss is rare (30).
Det kunstige akrylneglesystem består af en væske og et pulver.
The acrylic artificial nail system consists of a liquid and a powder.
2hydroxypropylmethakrylat og ethylendimethakrylat blev fundet i væsken, der anvendes til at opbygge kunstige negle af akryl.
2Hydroxypropyl methacrylate and ethylene dimethacrylate was found in the liquid used to develop the acrylic artificial nail.
Fem forskellige væsker indeholdt de to akrylater i koncentrationer fra 0,89 til 15 % (tabel 4.3).
Five different liquids contained the two acrylates in concentrations from 0.89 to 15% (table 4.3).
Den højest fundne mængde var 10,25 % for 2-hydroxypropylmethakrylat og 15 % for ethylendimethakrylat.
The maximum amount found was 10.25% for 2-hydroxypropyl methacrylate and 15% for ethylene dimethacrylate.
Pulveret indeholdt ingen af de analyserede akrylater.
The powder contained none of the analysed acrylates.
På basis af humane lappetests og dyrestudier blev de to akrylater vurderet som svagt allergifremkaldende i en koncentration på 2 %.
Based on human patch tests and animal studies the two acrylates are evaluated as weak sensitisers in a concentration of 2%.
Der blev dog fundet helt op til 15 % af en af akrylaterne i et af produkterne.
However, in these products up to 15% of one acrylate has been observed.
Stoffernes potentiale til at kunne elicitere allergi i mindst 13 % af de testede personer når de blev testet i en koncentration af 2 % indikerer, at koncentrationer på 10-15 % kan udgøre en alvorlig risiko for allergi.
The substances potential to elicitate sensitisation in minimum 13% of the tested persons, when tested in a concentration of 2% indicates that concentrations of 10-15% may pose a significant risk of sensitisation.
Det vurderes, at risikoen kan minimeres ved at undgå hudkontakt.
It is evaluated that the risk can be minimised by avoiding skin contact.
Det er vigtigt, at produkterne smøres meget præcist på neglen for derved at undgå kontakt med den omliggende hud.
The very central point is not by accident to smear the product outside the nail, and thereby avoid contact with the surrounding skin.
Ved at undgå hudkontakt vurderes det, at risikoen for allergiske hudreaktioner kan nedbringes betydeligt.
By avoiding skin contact it is evaluated that the risk of sensitisation is considerably lowered.
2-Hydroxyethylakrylat blev fundet i 6 af 7 analyserede gelénegleprodukter i koncentrationer fra 3,05 til 8,25 %.
2-Hydroxyethyl acrylate was found in 6 out of 7 analysed gel nail products in concentrations from 3.05 to 8.25 %.
2Hydroxypropylmethakrylat blev fundet i 4 af 7 produkter men i lavere koncentrationer fra 0,041 til 0,865 %.
2-Hydroxypropyl acrylate was found in 4 out of 7 products, but in lower concentrations; from 0.041 to 0.865.
2-hydroxypropylmethakrylat er det hyppigst forekommende stof af de analyserede akrylater i gelénegle.
2-Hydroxyethyl acrylate is clearly the most frequent substance of the analysed acrylates in gel nails.
2-Hydroxymethakrylat og 2-hydroxypropylmethakrylat blev på basis af humane lappetests vurderet som moderat allergifremkaldende.
Based on human patch tests and animal studies 2-hydroxyethyl acrylate and 2-hydroxypropyl acrylate are evaluated as moderate sensitisers.
De to akrylater er fundet at fremkalde allergiske reaktioner hos et stort antal personer (> 8 % af akrylat-overfølsomme personer) i en koncentration på 0,1 %.
The two acrylates is found to elicitate allergic reactions in a considerable number of humans (> 8% of acrylate-sensitised subjects) in a concentration of 0.1%.
Akrylaterne vurderes at have et højere potentiale som sensibiliserende end de methakrylater, der findes i akrylnegle.
The acrylates are evaluated to have a higher potential as sensitisers than the methacrylates found in acrylic nails.
Dette indikerer, at brugen af gelénegle kan udgøre en højere risiko for sensibilisering end akrylnegle.
This indicates that the use of gel nails may pose a higher risk of sensitisation than acrylic nails.
7.2.4 Overordnet diskussion om kunstige negle
7.2.4 Overall discussion on artificial nails
Risikovurderingen viste, at anvendelse af kunstrige negle ikke vil udgøre en risiko for systemiske effekter.
It was shown in the risk assessment that use of artificial nails will pose no risk of systemic effects.
Imidlertid, viste vurderingerne, at mængden af akrylater i produkterne har betydning for brugerens sundhedsrisici mht. allergi.
However, the assessments showed that the amounts of acrylates in the products are important for the health risks of the user regarding the sensitisation potential.
Denne kortlægning omhandler kun få akrylater.
This survey only handled a few acrylates.
Kortlægningen viste desuden, at den potentielle risiko for kontaktallergi synes at være højere for geléneglesystemet end for de kunstige akrylnegle (liquid and powder) baseret på indholdet af akrylater i produkterne.
The survey further showed that the potential risk of contact allergy seems higher for the gel nail system than for the acrylic artificial nails (liquid and powder) based on the content of acrylates in the products.
Formålet med dette kortlægningsprojekt var
The objective of this survey was
♦ At kortlægge forekomsten af allergifremkaldende kemikalier i neglehærdere og produkter til fremstilling af kunstige negle, der forhandles til private i detailhandlen, over internettet samt i produkter fra skønhedsklinikker.
♦ To make a survey of allergy causing chemicals in nail hardeners and products for manufacture of artificial nails to be sold to private persons from the retail trade, the internet and beauty shops.
♦ At udføre sundhedsmæssig risikovurdering af udvalgte kemikalier fundet i analysen.
♦ To perform health risk assessment of selected chemicals found during the analyses
♦ At komme med et forslag til en sikker koncentration af formaldehyd i neglehærder.
♦ To suggest a safe concentration of formaldehyde in nail hardeners.
Et bredt udvalg af produkter blev indkøbt.
A wide selection of products was purchased.
Neglehærdere blev indkøbt i detailhandlen, mens produkter til kunstige negle udelukkende viste sig at kunne indkøbes via internettet.
Nail hardeners were purchased from the retail trade, while products for artificial nails could only be purchased from the internet.
De indkøbte produkter blev gennemgået for indholdsstoffer og deres mærkning.
The purchased products were examined for ingredients and their labelling was assessed.
Denne gennemgang viste, at mange af produkter har store mangler i forhold til kravene om mærkning.
Many of the examined products appeared not to be in accordance with the demanded labelling requirements.
De mest markante mangler er forkert udført indholdsdeklaration og manglende brugsanvisninger.
Most significant was the insuffiently prepared ingredient declaration and the lacking directions for use.
Denne mangel på brugsanvisninger for især kunstige negleprodukter skal i øvrigt sammenholdes med, at denne undersøgelse viser, at det er vigtigt, at produkterne pålægges neglen rigtig for at undgå sundhedsmæssige risici.
As shown in this survey, directions for use are imperative especially for artificial nail products to secure a correct application of the products on the nails, which is extremely important to avoid allergy health risks.
Neglehærderne blev undersøgt for frit formaldehyd, mens de kunstige negle blev undersøgt for forskellige akrylforbindelser.
Nail hardeners were examined for free formaldehyde while the artificial nails were examined for different acrylic compounds.
Ingen af de undersøgte neglehærdere indeholdt mere end de tilladte 5 % formaldehyd.
None of the examined nail hardeners contained more than the permitted 5% formaldehyde.
Kun et produkt havde ikke angivet formaldehyd på ingredienslisten, selvom indholdet i produktet var større end de mærkningspligtige 0.05 %.
For only one product, formaldehyde was not on the list of ingredients, even if the content was greater than the demanded labelling requirement of 0.05%.
Undersøgelserne viste, at indholdet af akrylater er meget svingende fra produkt til produkt.
The investigations showed that the content of acrylates is very different from product to product.
Under dette projekts rammer var det dog ikke muligt at få klarlagt produkternes fulde sammensætning.
Within the framework of this project it was not possible to identify the complete composition of the products.
Den sundhedsmæssige vurdering af produkterne viste, at især kontaktallergi er den kritiske effekt af de undersøgte ingredienser i produkterne.
The health assessment of the products showed that especially contact allergy is the critical effect of the examined ingredients of the products.
For neglehærderne blev der opstillet et realistisk worst-case scenario, hvor risikoen for systemiske effekter ved brug blev udregnet.
A realistic worst-case scenario was set up for nail hardeners and the risk of systemic effects when using nail hardeners was calculated.
Dette viste, at der ikke er nogen risiko for systemiske effekter ved brug af neglehærdere indeholdende den i dag tilladte mængde af 5 % formaldehyd.
The calculation showed that there is no risk of systemic effects when using nail hardeners containing the permitted amount of formaldehyde which is 5%.
Da formaldehyd kan fordampe i løbet af processen anbefales det dog at lufte ud efter anvendelse af neglehærder for at begrænse eksponeringen mest muligt ved indånding og deponering af dampe på huden.
As formaldehyde can evaporate during the process, it is recommended to let in some air after application of nail hardeners to limit the exposure most possible by inhalation and deposition of vapour on the skin.
Formaldehyd kan medføre allergi og er klassificeret som allergifremkaldende.
Formaldehyde may cause allergy and is classified as allergenic.
Elicitering af allergi er observeret hos formaldehyd-overfølsomme personer i
Elicitation of allergy has been observed in formaldehyde sensitive persons in concentrations
koncentrationer helt ned til 0,05 % formaldehyd, mens induktion af allergi i dyrestudier ses ved omkring 0,4 - 0,96 % formaldehyd.
down to 0.05% formaldehyde, while induction of allergy in animal studies is seen at about 0.4 - 0.96% formaldehyde.
Den største risiko for allergi forventes at forekomme, hvis neglehærderen kommer i kontakt med huden.
The greatest risk of allergy is expected to develop if the nail hardener comes into contact with the skin.
Ligeledes er irritation og allergi beskrevet i tilfælde, hvor neglehærder påsmøres ødelagte negle.
Irritation and allergy may also occur, if nail hardeners are applied on broken nails.
Herved kan formaldehyd komme i kontakt med vævet under neglen, hvilket forøger risikoen for irritation og udvikling af allergi.
In this case, formaldehyde may come into contact with the tissue under the nail and the risk of irritation and allergy will increase.
På baggrund af det materiale, der er genereret i dette projekt, vurderes den tilladte koncentration på 5 %, at kunne udgøre en risiko i forhold til induktion af allergi hos raske personer samt en høj risiko for elicitering af allergi hos formaldehyd-overfølsomme personer.
On the basis of the material generated in this project the permitted concentration of 5% is assessed to constitute a risk of allergy induction in healthy persons and a high risk of elicitation of allergy in formaldehyde sensitive persons.
På baggrund af den litteratur, der præsenteres i denne rapport vurderes en maksimal koncentration på 0,01 % formaldehyd i neglehærdere at være en sikker koncentration i forhold til risikoen for allergi ved brug både for raske personer og for personer, som allerede lider af allergi.
Based on the literature presented in this report, a maximum concentration of 0.01% formaldehyde in nail hardeners is assessed to be a safe concentration compared with the risk of allergy when applied both by healthy persons and persons already suffering from allergy.
Hvis formålet er, at forhindre at raske personer udvikler formaldehydallergi, kan der argumenteres for en højere koncentrationsgrænse.
If the objective is to prevent healthy persons from developing formaldehyde allergy, a higher limit of concentration may be argued.
Denne er dog svær at fastsætte idet, der ikke foreligger en klar grænseværdi for induktion af formaldehydallergi ved denne eksponeringsform.
However, this is difficult to set as there is no existing clear limit value for induction of formaldehyde allergy for this type of exposure.
Formaldehyd er tilladt som konserveringsmiddel i kosmetik i en koncentration på 0,2 %.
Formaldehyde is permitted as preservative in cosmetic products in a concentration of 0.2%.
Der kan argumenteres for, at koncentrationen i neglehærdere som minimum ikke bør overskride denne grænse for at mindske risikoen for induktion af allergi i raske personer.
It can be argued that the concentration in nail hardeners as a minimum should not exceed this limit to diminish the risk of induction of allergy in healthy persons.
For allerede overfølsomme personer bør en advarsel på produktet om indhold af formaldehyd i en koncentration over 0,05 % advare den følsomme forbruger.
A warning to already sensitive persons should appear on the product about the content of formaldehyde in a concentration above 0.05%.
EU's videnskabelige komité for forbrugerprodukter (SCCP) er blevet anmodet om, at vurdere en sikker grænseværdi for indholdet af formaldehyd i neglehærder.
The Scientific Committee of Consumer Products (SCCP) of EU has been requested to assess a safe limit value of the content of formaldehyde in nail hardeners.
Undersøgelsen har desuden vist, at flere neglehærdere på det danske marked indeholder under 1 % formaldehyd (4 ud af 6 testede).
This survey showed that several nail hardeners on the Danish market contains below 1% formaldehyde (4 out of 6 tested).
Der findes derfor alternativer til de produkter, som indeholder højere mængder af formaldehyd.
Therefore, there are alternatives to the products containing larger amounts of formaldehyde.
Et produkt af de seks testede indeholder kun 0,01 % formaldehyd.
One of the six tested products only contains 0.01% formaldehyde.