Registration Dossier
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EC number: 202-785-7 | CAS number: 99-76-3
- 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

Endpoint summary
Administrative data
Description of key information
Skin irritation:
3 studies (1 key study/2 supporting studies) available: mildly/not irritating
Eye irritation:
1 study available: minimally transient irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Three studies are available that examined the skin irritancy potential of Methylparaben. For two of them only basic facts are reported but one detailed study clearly demonstrates that the skin irritation potential is minimal to negligible. This conclusion is consistently supported by the other studies which did not show any skin irritation after Methylparaben treatment in humans and rabbits.
There is limited data available on the eye irritancy potential. The study was performed according to the Eye Irritation Test Design (modified Draize) and reported in sufficient detail to be able to ascertain that the substance has very low eye irritancy potential (irritation score 1/110, 6 animals), with effects disappearing within 48 hours of instillation of the substance into rabbit eyes.
Justification for classification or non-classification
The substance is not irritating to the skin following single application and does not meet the criteria for classification as a skin irritant.
There is limited but sufficient data available on the eye irritancy potential to conclude that the substance does not meet the criteria to be classified as irritating to the eye.
It can reasonably be deduced that Methylparaben ether does not cause respiratory tract irritation and thus does not have to be classified, because the substance did cause only slight, fully reversible irritative effects in the eyes and the skin. It does not have to be classified as either skin or eye irritating. Therefore, Methylparaben, in the unlikely event of being inhaled as a dust, is considered not to cause severe effects, due to its not- irritating properties on skin and eye. A harmful interaction with living cells and tissues is very unlikely (as demonstrated by the in vivo skin and eye irritation studies).
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