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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- The skin sensitization potential of enzymes has recently been reviewed by Basketter et al., British Journal of dermatology 158 (2008), HERA alpha-amylases, cellulases and lipases (2005) and HERA Subtilisins (Proteases) (2007) revealing that enzymes should not be considered skin sensitizers. The Association of Manufacturers and Formulators of Enzyme Products (www.amfep.org) performed an evaluation of the safety profile and published a statement that enzymes do not have skin sensitizing potential. The lack of skin sensitizing potential is substantiated by evidence from robust human experimental data and extensive in-use human studies performed with detergents containing enzymes (Bannan, E.A., et al., Journal of Toxicology - Cutaneous and Ocular Toxicology 11 (1983); Griffith, J.F., et al., Food and Cosmetics Toxicology 7 (1969); Rodriguez, C., et al., Journal of Toxicology - Cutaneous and Ocular Toxicology 13 (1994); Cormier, E.M., et al., Annals of Allergy Asthma and Immunology 92 (2004); White, I.R., et al., Contact Dermatitis 13 (1985). All of these studies confirmed that the presence of enzymes used in detergents did not result in contact skin sensitization, including those conducted with atopic individuals.
This conclusion is based on the following considerations (references are included on the site):
• The results of predictive testing in man demonstrate that enzymes do not have skin sensitization potential for man.
• In clinical settings, enzymes have only very rarely been suggested as a possible cause of allergic contact dermatitis (ACD). Even in these few cases, a causal relationship has never been proven. Further, several clinical studies have demonstrated that enzymes are not a cause of ACD.
• ACD has never been reported in the detergent enzyme industries where there has been extensive occupational enzyme exposure which, in the past, led to respiratory sensitization and/or irritant dermatitis. For more than 40 years, billions of consumers have had regular, often daily, skin exposure to enzymes during laundry by hand but there is no evidence that this exposure has given rise to skin sensitization.
• The available skin sensitization test methods are not suitable for enzymes. No animal model has been developed or validated for assessing proteins as contact skin sensitizers. So far, no in vitro models exist either.
The skin sensitizing potential of enzymes has been reviewed in multiple publications and all authors conclude that enzymes in general do not produce dermal sensitization (Collection of information on enzymes, European Commission (2002); Ladics and Sewalt, Regulatory Toxicology and Pharmacology (2018); Basketter et al., Journal of Immunotoxicology (2012)). Furthermore, there is no suitable test for (high molecular weight) proteins such as enzymes. In vivo skin sensitization assays such as the guinea pig maximization test and LLNA are not applicable to enzymes . However, the clinical experience with enzymes used in detergent products clearly shows a lack of contact skin sensitization potential (Basketter, D., et al., Regulatory Toxicology and Pharmacology 64 (2012)).
In conclusion, since enzymes are well documented not to be skin sensitizers in man and because no suitable animal model or in vitro assay for protein skin sensitization exists, testing enzymes in animal models developed for chemical contact allergens is concluded to be both scientifically and ethically unjustified.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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