natgillin/translations-raw huggingface dataset:
8.6.6 Konklusion på forekomst af dodecamethylpentasiloxan i imprægneringsspray
8.6.6 Conclusion on the appearance of dodecamethylpentasiloxane in proofing spray
Der er rapporteret et studie med oral absorption, distribution, metabolisme og udskillelse (ADME) af polydimethylsiloxaner i rotte, hvorfra et akut no observed effect level på 600 mg/kg lgv kunne fastsættes.
A study with oral absorption, distribution, metabolism and elimination (ADME) of polydimethylsiloxanes in rats has been reported and therefore an acute no observed effect level of 600 mg/kg bw could be determined.
Sammenholdt med værste tilfælde scenario kunne beregnes margins of safety (MOS) på mindst 192 for mænd og 164 for kvinder for den eneste sprayvæske, hvor dodecamethylpentasiloxan er målt.
Compared with the worst case scenario, margins of safety (MOS) could be calculated of at least 192 for males and 164 for females for the only spray liquid in which dodecamethylpentasiloxane was measured.
Disse sikkerhedsmarginer er acceptable.
These safety margins are acceptable.
Der er ikke fundet data, som muliggør vurdering af en eventuel mekanisk virkning af polydimethylsiloxaner på lungerne.
Data has not been found that would render an assessment of a possible mechanical effect of fluortelomer alcohols on the lungs possible.
I aerosoler bestående af polydimethylsiloxaner (med ekstremt lavt damptryk) og opløsningsmidler med forholdssvis højt damptryk vil opløsningsmidlet hurtigt fordampe - jo mindre aerosolpartiklerne er, desto hurtigere fordampning.
In aerosols consisting of fluortelomer alcohols (with extremely low steam pressure) and solvents with rather high steam pressure the solvent would quickly evaporate - the smaller the aerosols, the quicker the evaporation.
Det betyder i praksis, at aerosoler som indåndes, hovedsaglig vil bestå af det tungtflygtige imprægneringsstof (polydimethylsiloxaner).
In practice that means that aerosols that are inhaled mainly will consist of the heavy volatile proofing agent (polydimethylsiloxanes).
8.7 Opsamling på sundhedsvurdering og videnindsamling
8.7 Recapitulation on health assessment and information collection
Der er i dette afsnit gennemført sundhedsvurderinger for 6 stoffer, fundet enten ved de semikvantitative screeninger eller ved de kvantitative analyser af kemiske stoffer i sprayprodukter beregnet til tekstilimprægnering.
In this chapter, health assessments were carried out on 6 substances found either through semi-quantitative screenings or through quantitative analyses of chemical substances in spray products intended for textile proofing.
Vurderinger af de sundhedsmæssige forhold er foretaget ud fra opstillede worst case-scenarier.
Assessments of the health related conditions were carried out in the light of the worst case scenarios that had been set up.
Vurderingerne viste, at indhold af organiske opløsningsmidler ikke i sig selv udgør et sundhedsmæssigt problem i disse sprayprodukter.
The assessments demonstrated that the content of organic solvent in these spray products in itself does not compose a health hazardous problem.
Heller ikke indholdet af en polydimethylsiloxan, der blev fundet i et enkelt sprayprodukt vil ud fra de gennemførte beregninger kunne udgøre nogen sundhedsmæssig risiko.
The content of polydimethylsiloxane found in one single spray product based on the calculations that were carried out cannot constitute a health hazardous risk.
Baseret på målinger af koncentrationer af stoffer, der ligner en bestemt fluortelomeralkohol og sammenholdt med de få toksikologiske data, der er til rådighed for dette og lignende stoffer, blev kun fundet en meget lav sikkerhedsmargin i forhold til det opstillede worst case-scenario.
Based on measurements of substance concentrations that look like a certain fluortelomer alcohol and compared with the small amount of toxicological data that is available for this and similar substances only a very low safety margin was found compared to the worst case scenario that was set up.
Ud fra analysedata skulle produkterne ved brug i den foreliggende form ikke i sig selv udgøre en sundhedsmæssig risiko, men for kemiske stoffer i forbrugerprodukter kræves en margin of safety (MOS) på mindst 100, hvor en 10-faktor bruges til at ekstrapolere fra dyrestudier til eksponering af mennesker og en anden 10-faktor bruges til at tage højde for at visse grupper eller individer kan være langt mere følsomme end andre.
On the basis of the analysis data, the products should not during use in the present form in themselves compose a health hazardous risk, but for chemical substances in consumer products a margin of safety (MOS) of at least 100 is required and a factor 10 is used to extrapolate from animal studies to exposure of humans and another factor 10 is used to take particularly sensitive groups or individuals into account.
Dette krav vurderes ikke at være opfyldt for en række stoffer i flere af produkterne.
It is believed that several of the products do not fulfil that requirement.
Der er for disse stoffer yderligere grunde til at råde til forsigtighed og bruge stor sikkerhedsmargin.
In connection with these substances there are additional reasons to recommend cautiousness and to use a large safety margin.
Det gennemførte litteraturstudie af tilgængelig viden om forgiftningstilfælde forårsaget af tekstilimprægneringsvæsker viste, at langt hovedparten af alle registrerede forgiftningstilfælde netop er sket med sprayvæsker indeholdende organiske perfluoriderede polymerer.
The literature study that was carried out by using available information about cases of poisoning caused by textile proofing agents demonstrated that the main part of all registered cases of poisoning precisely have occurred when using spray liquids containing organic perfluorinated polymers.
Desuden er samme observation rapporteret af Lyngenbo et al. (2007).
In addition, the same obersvation was reported by Lyngenbo et al. (2007).
Denne undersøgelse er en opgørelse af de til Giftinformationscentralen fra 1991 til 2007 indrapporterede forgiftningstilfælde, der har involveret sprays til overfladebehandling af mange forskellige materialer.
That investigation specifies the cases of poisoning that were reported to the Danish Poison Information Centre from 1991 to 2007 and that have involved sprays for surface treatment of many different materials.
Af de 84 tilfælde indeholdt den overvejende del af de sprays, for hvilke forgiftningstilfælde er rapporteret, en fluorholdig forbindelse.
In 84 of the cases, the majority of the sprays reported for cases of poisoning contained a fluorine compound.
I sammenstillingen konkluderes dog: At grunden til og mekanismen for lungesygdommene ikke er kendte, og at forebyggelse af problemet ikke er ligetil.
However, it is concluded: the cause and mechanism of the lung diseases is not known and prevention of the problem is not straightforward.
Endelig er problemet måske større og mere uoverskueligt end analyseresultaterne i dette projekt afslører.
Finally, the problem might be greater and more confusing than the analysis results in this project disclose.
Der blev i forbindelse med screeningsundersøgelserne fundet højt indhold af fluor i flere produkter, end der blev analyseret fluortelomeralkohol-lignende stoffer i.
In connection with the screeing investigations a high content of fluorine was found in more products than in which substances similar to fluortelomer alcohol were analysed.
Der er derfor kun redegjort for en lille del af dette fluor.
Therefore, an account has only been given for a small part of that fluorine.
Det er imidlertid muligt, at forbrugeren kan blive eksponeret for ikke-polymeriserede fluorforbindelser i ret høje koncentrationer.
However, it is possible that the consumer can be exposed to non-polymerized fluorine compounds in rather high concentrations.
Den nøjagtige identitet af stofferne kendes ikke, men hvis man antager, at de kan sammenlignes med FTOH 6:2, så kan de udgøre et væsentligt problem, som det dog ikke har været muligt at omfatte i den gennemførte sundhedsvurdering.
The exact identities of the substances are not known but if it is assumed that they can be compared to FTOH 6:2, then they can form a substantial problem which it has not been possible to include in the health assessment that was carried out.
Der er ikke fundet data, som muliggør vurdering af en eventuel mekanisk virkning af imprægneringsstoffer på lungerne.
Data has not been found that would render an assessment of a possible mechanical effect of fluortelomer alcohols on the lungs possible.
I aerosoler bestående af imprægneringsstoffer, som har et ekstremt lavt damptryk, og opløsningsmidler med forholdsvis højt damptryk, vil opløsningsmidlet hurtigt fordampe - jo mindre aerosolpartiklerne er, desto hurtigere fordampning.
In aerosols consisting of fluortelomer alcohols (with extremely low steam pressure) and solvents with rather high steam pressure the solvent would quickly evaporate - the smaller the aerosols, the quicker the evaporation.
Det betyder i praksis, at aerosoler, som indåndes, hovedsaglig vil bestå af det tungtflygtige imprægneringsstof, som i koncentreret form vil kunne påvirke overfladespændingsforholdene i lungerne og derved medføre en forandring af lungefunktionen.
In practice that means that aerosols that are inhaled mainly will consist of the heavy volatile proofing agent that in concentrated form that could influence the ratio of the surface tension in the lungs and in that way result in a change in the lung function.
Spraydåser må kun indeholde de driv- og opløsningsmidler, som er opført på bilaget til Miljøstyrelsens bekendtgørelse nr. 571 af 29/11/1984 om anvendelse af driv- og opløsningsmidler i aerosolbeholdere.
Spray cans are only allowed to contain the propellants and solvents stated in the enclosure to Regulation no. 571 dated 29/11/1984 on the use of propellants and solvents in aerosol cans from the Danish Environmental Protection Agency.
Det fremgår endvidere af dette bilag, at en række tilladte driv- og opløsningsmidler ikke må anvendes i kosmetiske produkter og i produkter til indendørs husholdningsbrug.
In addition, it appears from that enclosure that a number of allowed propellants or solvents must not be used in cosmetics or in products for indoor household use.
Det betyder, at de ikke må forekomme i koncentrationer på mere end 1 % med mindre, at Miljøstyrelsen har givet tilladelse dertil (§8 i bekendtgørelsen).
That means that they must not appear in concentrations of more than 1 % unless the Danish Environmental Protection Agency has given their permission (§8 in the Regulation).
De fleste af kortlagte sprayprodukter markedsføres principielt til indendørs brug, idet ingen af produkterne er mærket, eller det på anden måde er anført, at det kun må anvendes udendørs, fx ”kun til udendørs brug”.
Most of the surveyed spray products are marketed principally for indoor use as none of the products are marked and it has not been stated in any other way that the product must only be used outdoors, e.g ”only for outdoor use”.
På andre produkter er anført at de skal bruges i det fri eller kun på steder med god ventiation.
On other products it is stated that they have to be used in the open or only in places with good ventilation.
I brugsvejledninger anbefales ofte ventilation på behandlingsstedet.
Directions for use often recommend ventilation at the place of treatment.
8.7.2.1 Butylacetat i de undersøgte produkter
8.7.2.1 Butyl acetate in the investigated products
I bilaget til forannævnte bekendtgørelse er anført summen af butylacetater, som omfatter 1-butylacetat (n-butylacetat), 2-butylacetat og tert-butylacetat.
In the enclosure of the previously mentioned Regulation the amount of butyl acetate is stated comprising 1-butyl acetate (n-butyl acetate), 2-butyl acetate and tert-butyl acetate.
De 2 sidstnævnte er ikke fundet i noget produkt ved semikvantitativ screening.
The 2 last mentioned were not found in any product by semi-quantitative screening.
Butylacetater må således ikke anvendes som opløsningsmidler i spraydåser til indendørs husholdningsbrug, medmindre Miljøstyrelsen har givet dispensation.
Therefore, butyl acetates must not be used as solvents in spray cans for indoor household use unless the Danish Environmental Protection Agency has given dispensation.
For produkterne nr. 3, 14 og 15 er indhold af butylacetat deklareret på sikkerhedsdatabladet.
In connection with product no. 3, 14 and 15 the content of butyl acetate has been declared on the safety data sheet.
De indeholder henholdsvis 2, 8 og 3,9 %.
They contain 2, 8 and 3.9 %, respectively.
På sikkerhedsdatabladet for produkt nr. 14 er indholdet af n-butylacetat deklareret til 1-5 %.
On the safety data sheet of product no. 14 the content of n-butyl acetate has been declared to 1-5 %.
For produkterne nr. 1 og 9 er indhold af butylacetat ikke deklareret, men de indeholder henholdsvis 9,8 og 2,3 %.
In connection with product no. 1 and 9 the content of butylacetate has not been declared, but they contain 9.8 and 2.3 %, respectively.
For produkterne nr. 16 og 25 er indhold af butylacetat ikke deklareret.
In connection with product no. 16 and 25 the content of butylacetate has not been declared.
Ved analyse er der fundet henholdsvis 0,0058 og 0,0065 %.
Analyses have shown 0.0058 and 0.0065 %, respectively.
Indholdet er så lavt, at det ikke er nødvendigt deklarere.
The content is very low and therefore it does not have to be declared.
I forhold til reglerne i bekendtgørelse nr. 571 fra 29/11/1984 om anvendelse af driv- og opløsningsmidler i aerosolbeholdere overskrider produkter nr. 1, 3, 9, 14 og 15 således den tilladte koncentration af butylacetat i aerosoler beregnet til indendørs husholdningsbrug.
Compared to the rules in Regulation no. 571 dated 29/11/1984 concerning the use of propellants and solvents in aerosol cans product no. 1, 3, 9, 14 and 15 exceed the allowed concentration of butyl acetate in aerosols intended for indoor household use.
8.7.2.2 Butanon i de undersøgte produkter
8.7.2.2 Butanone in the investigated products
I bilaget til forannævnte bekendtgørelse er butanon anført under betegnelsen methylethylketon.
In the enclosure of the previously mentioned Regulation butanone is stated under the description methyl ethyl ketone.
Der er identificeret butanon i produkterne nr. 8 og 21 ved SPME-GC/MS analyse.
Butanone was identified in product no. 8 and 21 by SPME-GC/MS analysis.
8.7.2.3 Butan-1-ol i de undersøgte produkter
8.7.2.3 1-Butanol in the investigated products
I bilaget til forannævnte bekendtgørelse er anført summen af butanoler, som omfatter 1-butanol (n-butanol), 2-butanol og tert-butanol.
In the enclosure of the previously mentioned Regulation, the amount of butanol is stated comprising 1-Butanol (n-Butanol), 2-Butanol and tert-butanol.
De 2 sidstnævnte er ikke fundet i noget produkt ved semikvantitativ screening.
The 2 latter were not found in any product by semi-quantitative screening.
Der er identificeret butan-1-ol i produkterne nr. 18, 20, 25 og 26 ved SPME-GC/MS screening af samtlige produkter.
1-Butanol was identified in product no. 18, 20, 25 and 26 by SPME-GC/MS screening of all products.
Ved de kvantitative analyser blev der ikke fundet butan-1-ol i mængder over detektionsgrænsen i analyserede produkter (nr. 18, 25 og 26).
In connection with the quantitative analyses 1-Butanol was not found in amounts exceeding the detection limit in analysed products (no. 18, 25 and 26).
8.7.2.4 Cyclohexan i de undersøgte produkter
8.7.2.4 Cyclohexane in the investigated products
Cyclohexan er anført i bilaget til forannævnte bekendtgørelse.
Cyclohexane is stated in the enclosure of the previously mentioned Regulation.
De tre analyserede produkter, nr. 1, 3 og 8, indeholder cyclohexan i koncentrationer på henholdsvis 0,65, 0,029 og 0,60 %.
The three analysed products no. 1, 3 and 8 contain cyclohexane in concentrations of 0.65, 0.029 and 0.60 %, respectively.
8.7.2.5 Perfluoroctan-1-ol i de undersøgte produkter
8.7.2.5 Perfluoroctane-1-ol in the investigated products
Perfluoroctan-1-ol er ikke anført i bilaget til forannævnte bekendtgørelse, da bekendtgørelsen udelukkende omhandler driv- og opløsningsmidler.
Perfluoroctane-1-ol is not stated in the enclosure of the previously mentioned Regulation as it solely deals with propellants and solvents.
Perfluoroctan-1-ol er ikke blevet fundet i produkterne.
Perfluorctane-1-ol was not found in the products.
Tilsvarende gælder for produkterne nr. 8 og 21.
The same goes for product no. 8 and 21.
Ingen af de analyserede produkter deklarerer indholdet af fluorforbindelser, fordi der ikke er krav herom.
None of the analysed products declare the content of fluorine compounds as there is no requirement.
Forbrugeren kan efterlades med et indtryk af, at selve imprægneringsstoffet er lavtkogende, hydrogenerede nafta-fraktioner.
The consumer could get the impression that the proofing agent itself is low boiling, hydrogenated naftafractions.
8.7.2.6 Dodecamethylpentasiloxan i de undersøgte produkter
8.7.2.6 Dodecamethylpentasiloxane in the investigated products
Dodecamethylpentasiloxan er ikke anført i bilaget til forannævnte bekendtgørelse.
Dodecamethylpentasiloxane has not been stated in the enclosure of the previously mentioned Regulation.
Dodecamethylpentasiloxan er kun identificeret i produkt nr. 18 og bestemt kvantitativt til 0,66 g/kg. Ud fra et worst case-scenario er MOS beregnet til 192 for mænd og 164 for kvinder, hvilket er acceptabelt, idet der for kemiske stoffer i forbrugerprodukter kræves en MOS på mindst 100.
Dodecamethylpentasiloxane is only identified in product no. 18 and determined quantitavely to 0.66 g/kg. Based on a worst case scenario, MOS is calcualted to 192 for males and 164 for females which is acceptable as a MOS of at least 100 is required for chemical substances in consumer products.
8.7.3 Betydning af anvendelse af drivgas i spraydåser
8.7.3 Effects of propellants in spray cans
Forgiftningstilfælde ved brug af markedsførte imprægneringssprays i Tyskland, Holland og Schweiz har ikke medført alvorlige sundhedsproblemer som åndedrætsforstyrrelser eller lungeødemer, hvis aerosoltågerne ikke kan nå frem til det alveolære væv i lungerne.
Cases of toxification when using marketed proofing sprays in Germany, the Netherlands and Switzerland have not led to serious health problems such as respiratory diseases or pulmonary edema if the aerosol mists cannot reach the alveolar tissue in the lungs.
For at nå disse dele af lungerne (respirabel) skal dråbestørrelsen være mindre end ca. 4 µm.
In order to reach those parts of the lungs (respirable) the drop sizes have to be less than approx. 4 µm.
Denne dråbestørrelse opnås let, når produktet påføres under anvendelse af en drivgas og en tilsvarende lille dyse i sprayhovedet; som vist i denne undersøgelse.
That drop size is easily obtained when the product is applied when using a propellant and a correspondingly small nozzle in the spray head - as demonstrated in this investigation.
Når de samme væsker anvendes under brug af en pumpemekanisme, bliver dråberne ikke mindre end ca. 100 µm og kan derfor ikke nå frem til alveolerne.
When the same liquids are used when using a pump mechanism the drops do not become smaller than approx. 100 µm and therefore they cannot reach the alveolars.
En ny undersøgelse viser, at de registrerede forgiftningstilfælde i Danmark tilsyneladende alle har omfattet produkter med drivgas (se Bilag 1).
A new investigation shows that the registered cases of toxification in Denmark apparently all have comprised products with a propellant (see enclosure 1).
Det er påvist i nærværende projekt, at forbrugeren kan eksponeres for høje lokale koncentrationer af aerosoltåger med respirable aerosoler.
This project has demonstrated that the consumer can be exposed to high local concentrations of aerosol mists with respirable aerosols.
I forbindelse med anvendelse af tekstilimprægneringsmidler kan der dannes betydelige koncentrationer af fine (<1 µm) og ultrafine aerosoler (nanoaerosoler) (<100 nm), som må anses at være 100 % respirable.
In connection with using textile proofing agents considerable concentrations of fine (<1 µm) and ultra fine aerosols (nanoaerosols) (<100 nm) can be created and they must be regarded as being 100 % respirable.
Den eksisterende viden på området kan ikke dokumentere, at små aerosoler i sig selv er skadelige.
Existing knowledge in the field cannot document that small aerosols in themselves are harmful.
Aerosolerne kan være bærere af (re)aktive kemiske stoffer, fx fluorcarbon-monomerer, men betydningen heraf er heller ikke kendt, da de kemiske strukturer af de (re)aktive stoffer ikke kendes og ikke har kunnet fastlægges ud fra de gennemførte kemiske analyser.
Aerosols can be carriers of (re)active chemical substances, e.g. fluorcarbon monomers, but the effect is not know either, as the chemical structure of the (re)active substances is not known and it has not been possible to determine it on the basis of the chemical analyses that were carried out.
Forgiftningstilfælde i Tyskland med påstået nano-aerosolholdige sprayvæsker er blevet diskuteret af række af Tysklands førende eksperter (BfR, 2006 a).
Cases of toxification in Germany with claimed nanoaerosol containing spray liquids have been discussed by a number of German experts (BfR, 2006 a).
De kunne ikke opnå konsensus om en endelig toksikologisk vurdering af lungepåvirkningerne.
They could not agree on a final toxicological assessment of the effect on the lungs.
Eksperterne påpegede, at klassiske toksikologiske vurderinger af de enkelte indholdsstoffer i et produkt ikke er tilstrækkelige, når produktet sprayes ved hjælp af et drivgas.
The experts pointed out that the classic toxicological assessments of the individual substances in a product are not sufficient when the product is sprayed by means of a propellant.
Fysiske karakteristika, fx aerosolens størrelse er en bestemmende faktor for om og hvilken toksisk effekt, der vil kunne opstå i luftvejene.
Physical properties, e.g. aerosol size are determining factors for if and which toxicological effect could arise in the respiratory passages.
Man kunne derfor ikke se bort fra den mulighed, at de observerede toksiske effekter kan været opstået alene som resultat af aerosolanvendelsen, dvs. ikke en effekt af indånding af nanoaerosoler.
Therefore, it was not possible to disregard the possibility that the observed toxic effects could have arisen solely as a result of the aerosol use, meaning not an effect from inhalation of nanoaerosols.
Eksperterne var enige om, at sundhedseffekter af sprayprodukter med drivgas kun kan bestemmes ved hjælp af en teststrategi, der efterligner de faktiske anvendelsesforhold indendørs.
The experts agreed that the health effects of spray products with propellant only can be determined by means of a test streategy that copies the actual conditions of use indoors.
Toksiske virkninger ses kun, når selve produktet, det vil sige hele blandingen af stoffer i forbrugerproduktet, indåndes som en fin aerosol med den tilsvarende lille dråbestørrelse.
Toxic effects are only seen when the product itself, meaning the complete mixture of substances in the consumer product, is inhaled as a fine aerosol with the corresponding small drop size.
Dette gælder både for produkter med og uden nanoaerosoler.
That goes for products with as well as without nanoaerosols.
Som nævnt er den toksikologiske betydning af indånding af nanoaerosoler endnu ikke kendt.
As mentioned, the toxicological effect from inhaling nanoaerosols in not yet known.
Der foregår adskillige internationale forskningsaktiviteter vedrørende nanoaerosolers toksikologi, som i løbet af nogle år forhåbentlig kan kaste mere lys over denne problemstilling.
Several international research activities are taking place concerning the toxicity of nanoaerosols and in a couple of years they will hopefully shed more light on the problem.
8.7.4 Forslag til yderligere undersøgelser
8.7.4 Proposals for further investigations
For at kunne foretage en mere komplet sundhedsvurdering og afklare årsagerne til de sygdomstilfælde, der har været observeret i Danmark og i udlandet, er det nødvendigt med:
In order to carry out a more complete health assessment and clarify the reasons for the cases of illness that have been observed in Denmark and abroad it is necessary to have: