natgillin/translations-raw huggingface dataset:
Baseret på resultater fra dyrestudier, der vurderer eksponering for hydroxypropylakrylat og 2-hydroxypropylakrylat dampe, forventes der ingen reproduktionstoksicitet hos 2-hydroxypropylakrylat.
Based on results from animal studies evaluating exposure to hydroxypropyl acrylate and 2-hydroxyethyl acrylate vapours, no reproductive toxicity is anticipated for 2-hydroxypropyl acrylate.
Den kritiske effekt af 2-hydroxypropylakrylat er dets potentiale til at elicitere og inducere allergiske reaktioner og at irritere huden.
The critical effect of 2-hydroxypropyl acrylate is its potential to elicitate and induce allergic reactions and to irritate the skin.
Tabel 6.3 Sammenfatning af data for 2-hydroxpropylakrylat
Table 6.3 Summary of data for 2-hydroxpropyll acrylate
LOAEC, (mg/m3), inhalation, rotte
LOAEC, (mg/m3), inhalation, rat
≈ 7 mg/kg lgv/day
≈ 7 mg/kg bw/day
2-Hydroxypropylmethakrylat er en klar væske med en let akrylisk lugt (5).
2-Hydroxypropyl methacrylate is a dear liquid with a slightly acrylic odour (5).
1,2-Propanediol, 2-methyl, monomethakrylat, Hydroxypropyl methakrylate, Propylen glycolmonometakrylat
1,2-Propanediol, 2-methyl, monomethacrylate, Hydroxypropyl methacrylate, Propylene glycol monomethacrylate
2-hydroxypropylmethakrylat har en lav akut toksicitet.
2-Hydroxypropyl methacrylate has a low oral acute toxicity.
LD50 i rotter er 11.200 mg/kg lgv efter oral eksponering (19,24).
LD50 in rats is 11200 mg/kg bw after oral exposure (19,24).
Dampe af 2-hydroxypropylmethakrylat virker irriterende på øjne og åndedrætsorganer.
2-Hydroxypropyl methacrylate vapour is irritating to eyes and respiratory system.
Væsken virker irriterende på øjnene (5).
The liquid is irritating to eyes (5).
På marsvin viste 2-hydroxypropylmethakrylat et svagt potentiale for at inducere allergi i en maximisation test (24).
In guinea pigs 2-hydroxypropyl methacrylate had a weak potential to induce sensitisation in a maximisation test (24).
2-Hydroxypropylmethakrylat er observeret at kunne elicitere allergiske reaktioner i lappetests.
2-Hydroxypropyl methacrylate is observed to elicitate allergic reactions in patch tests.
17,5 % af de testede akrylat-overfølsomme patienter reagerede på 2-hydroxypropylmethakrylat i en koncentration på 2 % (21).
17.5% of the tested acrylate-sensitised patients were reacting to 2hydroxypropyl methacrylate in a concentration of 2% (21).
Toksicitet ved gentagen eller længevarende eksponering Der er ingen data fundet.
Toxicity from repeated or prolonged exposure No data found
I et rottestudie blev der fastsat en NOAEL på 1000 mg/kg lgv/dag for reproduktions- og udviklingseffekter, der viste, at 2hydroxypropylmethakrylat har et lavt potentiale til at kunne forårsage reproduktionstoksicitet (24).
In a rat study a NOAEL of 1000 mg/kg bw/day was established for reproductive and developmental effects indicating that 2-hydroxypropyl methacrylate has a low potential to cause reproductive toxicity (24).
2-Hydroxypropylmethakrylats kritiske effekter er dets potentiale til at kunne elicitere og inducere allergiske reaktioner.
The critical effects of 2-hydroxypropyl methacrylate are its potential to elicitate and induce allergic reactions.
En NOAEL blev fastsat i et reproduktionsstudie i rotter.
A NOAEL was established in a reproductive toxicity study in rats.
Tabel 6.4 Sammenfatning af data for 2-hydroxypropylmethakrylat
Table 6.4 Summary of data for 2-hydroxypropyl methacrylate
NOAEL, (mg/kg lgv/dag), reproduktionstoxicitet, rotte
NOAEL, (mg/kg bw/day), reprotoxicity, rat
Biologisk betragtet ligner methakrylat akrylat undtagen på lavere reaktivitet og således reduceret toksicitet.
Biologically, methacylates resemble acrylates, except for lower reactivity and thus decreased toxicity.
Dette skyldes sandsynligvis sterisk hindring af dets metylgrupper (5).
This is probably due to steric hindrance by its methyl group (5).
Ethylenglycoldimethakrylat, ethyldiol metakrylat, glycoldimethakrylat
Ethylene glycol dimethacrylate, ethyldiol metacrylate, glycol dimethacrylate
Ethylendimethakrylat har en lav akut toksicitet.
Ethylene dimethacrylate has a low acute toxicity.
Oral LD50 i mus er 2.000 mg/kg lgv, medens værdien er 3.300 mg/kg lgv i rotter (19).
LD50 orally in mice is 2,000 mg/kg bw, while in rats the value is 3,300 mg/kg bw (19).
Ethylendimethakrylat virker irriterende på øjne og åndedrætsorganer (5).
Ethylene dimethacrylate is irritating to eyes and respiratory tract (5).
Seksogtyve akrylat-overfølsomme individer blev testet med forskellige stoffer inklusiv ethylendimethakrylat ved en lappetest.
Twenty six acrylate-sensitised patients were tested with various substances including ethylene dimethacrylate in a patch test.
I en anden human lappetest reagerede 13 % af de akrylat-overfølsomme patienter positivt over for ethylendimethakrylat i en 2 % koncentration (21).
In another human patch test 13% of the acrylate-sensitised subjects reacted positive to ethylene dimethacrylate in a 2% concentration (21).
Baseret på en LLNA test, blev ethylendimethakrylat klassificeret som et svagt allergen.
Based on a Local Lymph Node Assay (LLNA) ethylene dimethacrylate was classified with an extremely weak potency for sensitisation.
Koncentrationen, der forårsagede allergi var 35 % (25).
The concentration inducing sensitisation was 35% ethylene dimethacrylate (25).
Baseret på disse dyre- og menneskestudier vurderes det, at ethylendimethakrylat har et svagt allergifremkaldende potentiale.
Based on these animal and human studies it is evaluated that ethylene dimetacrylate have a weak potential as a sensitiser.
Toksicitet ved gentagen eller længerevarende eksponering Gentagen eksponering via inhalation med ethylendimethakrylat (6 t/dag, for 13 eksponeringer af rotter) i en koncentration på 1 mg/m
Toxicity from repeated or prolonged exposure Repeated exposure to ethylene dimethacrylate (6 hr/day, for 13 exposures to rats) in a concentration of 1 mg/m
forårsagede let døsighed.
produced slightly lethargy.
Legemsvægt og urinparametre forblev uændrede (26).
Body weights and urine parameters were unchanged (26).
Ethylendimethakrylat viste sig ikke at være mutagent i Ames test (S. typhimurium) med eller uden aktivering (26).
Ethylene dimethacrylate was not mutagenic in Ames test (S. typhimurium) with or without activation (26).
Stoffet inducerede mutationer på TK gene locus i L5178Y muselymfeceller med metabolisk aktivering i koncentrationer fra 400 to 700 nl/ml.
The substance did induce mutations at the TK gene locus in L5178Y mouse lymphoma cells with metabolic activation in concentrations from 400 to 700 nl/ml.
Uden metabolisk aktivering forårsagede koncentrationer op til 800 nl/ml høj cytotoksicitet uden forhøjet mutation (5).
Without metabolic activation, concentrations up to 800 nl/ml caused high cytotoxicity without increasing mutation frequency (5).
Baseret på disse studier er ethylendimethakrylats mutagene potentiale ikke fuldstændig verificeret.
Based on these studies the mutagenic potential of ethylene dimethacrylate is not fully verified.
Reproduktionstoksicitet Der er ingen data fundet.
Reproductive toxicity No data found.
Ethylendimethakrylats kritiske effekter er stoffets evne til at frembringe og inducere allergiske reaktioner.
The critical effects of ethylene dimethacrylate are its potential to elicitate and induce allergic reactions.
Den systemiske eksponeringsdosis (Systemic Exposure Dose, SED) er fastsat i et worst-case scenario for en modelperson ved at anvende standardparametre fra TGD og SCCP.
The internal body dose (Systemic Exposure Dose, SED) is estimated in a worst case scenario for a model person by applying standard parameters from TGD and SCCP.
Sundhedsrisici for eksponering af udvalgte stoffer i neglehærdere og kunstige negle vurderes ved at kalkulere en sikkerhedsmargin (MoS).
The health risks of exposure to selected substances in nail hardeners and artificial nails are assessed by calculating the margin of safety (MoS).
Stoffers allergifremkaldende potentiale er dog ikke alene afhængige af det iboende potentiale, men også af dosis og eksponeringsmåde, antal af allergener pr. enhed hudoverflade, hjælpestoffet og hudens tilstand (29).
However, sensitisation of contact allergens are dependent not only on the inherent sensitisation capacity of the chemical, but also on the dose and type of exposure, the amount of allergen per unit area surface of skin, the vehicle and the condition of the skin (29).
Fastsættelse af en lavere tærskelværdi for henholdsvis induktion og elicitering af allergi kan være vanskelig, specielt til regulatorisk brug.
Establishment of a lower safe threshold concentration for the induction and elicitation of sensitisation may be difficult, particularly for use in regulatory toxicology.
En efterprøvet metode til risikovurdering af allergieffekten forefindes endnu ikke.
A validated method for risk assessment for the sensitisation effect has not yet been established.
Derfor er risikovurderingen nedenfor opdelt i en risikovurdering af de systemiske effekter og en del, der beskriver de potentielle risici for allergi.
Therefore the below risk assessment is split in a risk assessment of the systemic effects and a part describing the potential risk of sensitisation.
7.1 Eksponering og risikovurdering for forbrugere, der anvender neglehærdere
7.1 Exposure and risk assessment for consumers using nail hardeners
Formaldehyd i neglehærdere kan reagere med proteiner på overfladen af neglen og således blive inaktiveret hvis neglen er sund.
Depending on the applied concentration some of the formaldehyde may, however, penetrate the nail plate and reach the tissue under the nail.
Hvis neglen er skadet, kan formaldehyd trænge igennem den svage overflade ned til vævet under neglen.
This may especially be the case if the nail is thin, soft or damaged.
Formaldehyd kan også nå huden omkring neglen hvis produktet ikke smøres meget omhyggeligt på neglens overflade.
Formaldehyde may also reach the skin surrounding the nail if the product is not very carefully smeared on the nail plate.
Den daglige eksponering for formaldehyd i neglehærdere er blevet beregnet for en modelperson på 40 kg. Denne legemsvægt er baseret på en konservativ tilpasning, som i risikovurderingen også omfatter yngre piger fra 15 år og op.
The daily exposure of formaldehyde in nail hardeners has been calculated for a model person of 40 kg. This body weight is based on a conservative approach also including younger girls from 15 years and up in the risk assessment.
Den daglige eksponering blev beregnet for det højest tilladte indhold af formaldehyd i neglehærdere; 5 %.
The daily exposure was calculated for the highest allowed content of formaldehyde in nail hardeners; 5%.
Den maksimale mængde formaldehyd, der blev fundet i de analyserede produkter var 4,05 %.
The maximum amount of formaldehyde found in the analysed products was 4.05%.
Antal applikationer pr. dag:
Number of applications per day:
Mængde pr. applikation (10 negle):
Applied amount per application (10 nails):
7.1.1 Risikovurdering for systemiske effecter
7.1.1 Risk assessment for systemic effects
Det vurderes at mængden af formaldehyd i neglehærdere enten vil reagere med proteiner på neglens overflade, nå huden omkring neglen eller fordampe i løbet af neglehærderens tørringsproces.
It is assessed that the amount of formaldehyde in nail hardeners will either react with proteins on the surface of the nail, reach the skin surrounding the nail or evaporate during the drying process of the nail hardener.
Det vurderes at ca. 25 % af det totale indhold af formaldehyd i produktet vil fordampe under tørringsprocessen.
It is evaluated that around 25% of the total content of formaldehyde in the product will evaporate during the drying process.
Derfor vurderes det, at 9 % af de anvendte neglehærdere vil dække huden omkring neglen og at de derved bidrager til den systemiske dosis.
Therefore it is assumed that 9% of the applied nail hardeners will cover the skin surrounding the nail, and thereby may contribute to the systemic dose.
Det vurderes, at formaldehyd, der reagerer på negleoverfladerne ikke vil bidrage til den systemiske dosis, da man ikke kender de specifikke data for dette mulige bidrag.
It is assumed that none of the formaldehyde reacting on the nail plates will contribute to the systemic dose as no specific data for this possible contribution to a systemic dose is known.
Effekterne, der måtte opstå som følge af formaldehyds gennemtrængning af neglen omtales senere i kapitlet.
The possible effects of formaldehyde penetrating the nail are discussed later in the chapter.
Femogtyve procent formaldehyd vil fordampe i løbet af tørringsprocessen.
Twenty-five percent formaldehyde will evaporate during the drying process.
Det vurderes at det frigøres i det nære område rundt om personen (1 m
It is assumed that it is released in the close area around the person (1 m
at halvdelen af det absorberes via inhalation eller dermal absorption.
that half of it is absorbed via inhalation or dermal absorption.
Derfor omfatter beregningen af den systemiske eksponeringsdosis (SED) kun den del, der udgør huden omkring neglen (9 %) og halvdelen af den del, der fordamper under tørringsprocessen; 12,5 % af den totale del, der er indeholdt i produktet.
Therefore, calculating the systemic exposure dose (SED) only includes the part constituting the skin surrounding the nail (9%) and half the part evaporating during the drying process; 12.5% of the total amount contained in the product.
I alt vil 21,5 % af det totale indhold af formaldehyd bidrage til en systemisk dosis.
In total 21.5% of the total content of formaldehyde will contribute to a systemic dose.
Daglig eksponeringinhalation+dermal, formaldehyd:
Daily exposureinhalation+dermal, formaldehyde:
1 gang pr dag x 0,00025 kg neglehærder x 21,5 % x 50 g formaldehyd/kg produkt 40 kg lgv
1 time pr day x 0.00025 kg nail hardener x 21.5% x 50 g formaldehyde/kg product 40 kg bw
Den daglige eksponeringsdosis (SED) af formaldehyd i neglehærdere angives som mg pr kg legemsvægt pr dag (mg/kg lgv/dag) i testpersonen.
The daily exposure dose (SED) of formaldehyde in nail hardeners is calculated as mg per kg bodyweight per day (mg/kg bw/day) for the model person.
Normalt betragtes et kosmetisk produkt med en sikkerhedsmargin (MoS) på mere end 100 som et produkt, hvor brugeren eksponeres for en acceptabel (minimal) sundhedsrisiko(28).
Normally, a cosmetic product with a margin of safety (MoS) of more than 100 is considered to be a product exposing the user to an acceptable (minimum) health risk (28).
NO(A)EL (mg/kg lgv/d)
NO(A)EL (mg/kg bw/d)
Daglig dosis, voksen, 40 kg (SED) (mg/kg lgv/d)
Daily dose, adult, 40 kg (SED) (mg/kg bw/d)
Baseret på andre systemiske effekter end cancer
Based on systemic effects other than cancer
En kritisk effekt af formaldehyd er dets mulige potentiale som kræftfremkaldende.
A critical effect of formaldehyde is its possible potential as carcinogen.
Dette potentiale ses hos mennesker efter inhalation af store koncentrationer i arbejdsmiljøet (2).
The carcinogenic potential of formaldehyde is observed in humans after inhalation of large concentrations in the working environment (2).
er baseret på koncentrationen i arbejdsmiljøet på en arbejdsdag på 8 timer, hvilket svarer til en total koncentration på 3,2 mg/m
is based on the concentration in the working environment for a working day of 8 hours corresponding to a total concentration of 3.2 mg/m
Det vurderes, at 25 procent af den formaldehyd, der er indeholdt i neglehærderen vil fordampe i løbet af tørrringsprocessen.
It is assumed that 25 percent of the formaldehyde contained in the nail hardener will evaporate during the drying process.
(3 gange mindre end den totale grænseværdi), hvilket indikerer, at livstidsrisikoen for cancer ved brugen af neglehærdere er ubetydelig.
(3 times lower than the total threshold value) indicating that the life-time risk of cancer by using nail hardener is negligible.
7.1.2 Risikovurdering for allergi
7.1.2 Risk assessment for sensitisation
Baseret på publiceret litteratur er den kritiske effekt for neglehærdere allergiske hudreaktioner.
Based on published literature the most critical effect of nail hardeners are sensitisation.
Det er imidlertid vanskeligt at fastsætte en nedre sikker grænse for denne effekt.
However, it is difficult to establish a lower limit for this effect.
Derfor omfattede ovennævnte scenarie ikke denne effekt.
Thus the above exposure scenario did not include this effect.
En af de effekter, der blev observeret efter brug af neglehærdere er allergiske hudreaktioner på områder langt fra fingrene, almindeligvis øjenlåg, rundt om mund og kinder, siderne af nakken og på kønsorganerne (30),(31).
One of the effects observed after use of nail hardeners are dermatitis at sites distant from the fingers, commonly eyelids, around the mouth and chins, sides of the neck, and on the genitalia (30),(31).
Imidlertid ses også effekter direkte eller omkring fingerneglene (30).
However, effects directly at or around the finger nails are also observed (30).
Afhængigt af koncentrationen af anvendt formaldehyd og neglens fysiologiske tilstand, kan formaldehyd trænge igennem neglen og komme i kontakt med det underliggende væv.
Depending on the concentration of applied formaldehyde and the physiological condition of the nail, some formaldehyde may penetrate the nail plate and come into contact with the underlying tissue.
Indtil nu har der ikke været studier, der har identificeret mængden af formaldehyd, der kan trænge igennem neglen under forskellige forhold.
So far there have not been any scientific studies that have identified the amount of formaldehyde penetrating the nail under different conditions.
Der eksisterer derfor ingen kvantitative estimater for, hvor meget formaldehyd der vil kunne trænge igennem til det underliggende væv efter anvendelse af neglehærder.
Therefore, there are no quantitative estimates on how much formaldehyde there will be present at the underlying tissue after application of nail hardener.
Den mulige effekt af formaldehyds gennemtrængning af neglen kan være irritation af det underliggende væv eller allergiske reaktioner.
The possible effects may be irritation of the tissue under the nail and possible allergic reactions.
Formaldehyd har både et irriterende og allergifremkaldende potentiale.
Formaldehyde has both a irritating and sensitisation potential.
Med standard test protokoller har man observeret, at formaldehydkoncentrationer på 2 % eller højere kan forårsage hudirritation og allergiske hudreaktioner i ikke-overfølsomme individer (7).
With standard patch tests protocols it has been observed that formaldehyde concentrations of 2% and higher may produce skin irritation and sensitisation in non-sensitised individuals (7).
Baseret på et LLNA studie blev induktion af allergi observeret ved formaldehydkoncentrationer fra 0,4 til 0,96 % (9),(12).
Based on Local Lymph Node assays (LLNA) induction of sensitisation was observed at formaldehyde concentration from 0.4 to 0.96% (9),(12).
En lang række humane lappetests er blevet gennemført med formaldehyd gennem de sidste 30 år.
A large range of human patch tests has been performed with formaldehyde during the last 30 years.
Dette indikerer, at den lovlige mængde på 5 % formaldehyd i neglehærdere påfører brugerne en risiko for udvikling af formaldehydallergi.
This indicates that the legal amount of 5% formaldehyde in nail hardeners adds a risk of sensitisation to the users.
På basis af de data, der vises i sundhedsvurderingen, ville en maksimal tilladelig mængde formaldehyd på 0,01 % i neglehærdere anses for sikker for både ikke-overfølsomme og formaldehyd-overfølsomme personer, mens en højere koncentration kan anses for sikker for ikke følsomme personer.
Based on the data presented in the safety assessment a maximum allowable amount of formaldehyde of 0.01% in nail hardeners would be considered safe for both non-sensitive and formaldehyde-sensitised subjects, while a higher concentration may be considered safe for non-sensitized individuals.
EU's videnskabelige komité for forbrugerprodukter (SCCP) er for nylig blevet anmodet om at vurdere en sikker grænseværdi for indholdet af formaldehyd i neglehærder.
The scientific committee on consumer products (SCCP) has recently been requested for an opinion on formaldehyde in cosmetic products including the use in nail hardener products.
Denne vurdering kan hjælpe med til at finde frem til en sikker koncentration, hvor risikoen for formaldehydallergi vurderes acceptabel ved denne særlige eksponering.
This opinion may help establish a safe concentration for induction of formaldehyde allergy under this specific exposure.
Som tidligere beskrevet, afhænger allergi af kontaktallergener ikke alene af kemikaliets iboende egenskaber til fremkaldelse af allergi, men også af dosis og typen af eksponering, mængde allergen pr. overfladeareal, hjælpestofferne og hudens tilstand.
As described before, the sensitisation of contact allergens are dependent not only on the inherent sensitisation capacity of the chemical, but also on the dose and type of exposure, the amount of allergen per unit area surface of skin, the vehicle and the condition of the skin.
Sådanne data er ikke vurderet i dette projekt.
Such data has not been evaluated in this project.
Det kan dog hævdes, at en højere koncentration formaldehyd end 0,01 % i neglehærdere kan være ufarlig når man tager den begrænsede eksponering af huden under normalt brug af produkterne i betragtning.
However, it may be argued that a higher concentration of formaldehyde than 0.01% in nail hardeners may be safe based on the limited exposure of the skin during normal use of the products.
Den lovlige mængde formaldehyd som konserveringsmiddel i kosmetik er 0,2 %.
The legal amount of formaldehyde as a preservative in cosmetics is 0.2%.
SCCP's skøn kan muligvis afklare, om en højere koncentration end denne kan betragtes som ufarlig i neglehærdeprodukter.
The opinion from SCCP may clarify if a higher concentration than this can be considered safe in nail hardener products.
Desuden kan en advarsel om produkterne hjælpe med til at beskytte formaldehyd-overfølsomme personer.
Furthermore, a warning on the products may help protecting formaldehyde-sensitised individuals.
Produkterne kunne forsynes med en advarselslabel 'indeholder mere end 0,05 % formaldehyd'.
The products could be labelled with the warning ‘contains more than 0.05% formaldehyde'.
7.1.3 Overordnet diskussion om neglehærdere
7.1.3 Overall discussion on nail hardeners'
Sundhedsvurderingen af formaldehyd i neglehærdere viser, at den tilladte koncentration af frit formaldehyd i neglehærdere ikke giver sundhedsmæssige problemer i forhold til stoffets systemiske effekter.
The risk assessment of formaldehyde in nail hardeners shows that the allowable concentration of free formaldehyde in nail hardeners gives no health concerns regarding systemic effects of formaldehyde.
Den lovlige mængde formaldehyd synes dog høj i forbindelse med stoffets allergifremkaldende potentiale.
However, the legal allowable amount of formaldehyde seems high regarding the sensitisation potential of the substance.
For at undgå uacceptabelt mange induktioner af allergiske reaktioner og elicitation hos følsomme personer bør man diskutere, om en lavere koncentration er løsningen.
To avoid unacceptable numbers of induction of allergic reactions and elicitation in already sensitised individuals to this kind of products a lower concentration may be argued.
På basis af de data, der vises i sundhedsvurderingen, ville en maksimal koncentration på 0,01 % formaldehyd i neglehærdere betragtes som ufarlig for alle typer af brugere.
Based on the data presented in the safety assessment a maximum concentration of 0.01% formaldehyde in nail hardeners would be regarded as safe for all kind of users.
Det blev påvist, at adskillige produkter indeholdt lavere niveauer af formaldehyd (< 1 %) end de tilladte 5 %.
Several products were found to contain much lower levels of formaldehyde (< 1 %) than the allowed 5 %.
Dette viser, at det er muligt at producere neglehærdere med lavere niveauer af formaldehyd.
This shows that it is possible to produce nail hardeners with lower levels of formaldehyde.