Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-311-9 | CAS number: 94-18-8
- 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 vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Dermal contact dermatitis from benzylparaben.
- Author:
- A. TOSTI, P. A. FANTI AND S. PILERJ
- Year:
- 1 989
- Bibliographic source:
- Contact Dermatitis 1989: 21: 49-63
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- The patch test performed on woman for the benzylparaben.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- Benzyl 4-hydroxybenzoate
- EC Number:
- 202-311-9
- EC Name:
- Benzyl 4-hydroxybenzoate
- Cas Number:
- 94-18-8
- Molecular formula:
- C14H12O3
- IUPAC Name:
- benzyl 4-hydroxybenzoate
- Reference substance name:
- Benzoic acid, 4-hydroxy-, phenyl methyl ester
- IUPAC Name:
- Benzoic acid, 4-hydroxy-, phenyl methyl ester
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): Benzylparaben (Synonyms of Benzoic acid, 4-hydroxy-, phenyl methyl ester)
- Molecular formula (if other than submission substance): C14-H12-O3
- Molecular weight (if other than submission substance): 228.2458 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: 43 years old
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: No data available
- Vehicle:
- no data
- Concentration / amount:
- No data available
Challengeopen allclose all
- Route:
- other: No data available
- Vehicle:
- no data
- Concentration / amount:
- No data available
- No. of animals per dose:
- 1 woman
- Details on study design:
- Details on study design
RANGE FINDING TESTS: No data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: No data available
- Test groups: 1
- Control group: No data available
- Site: No data available
- Frequency of applications: 1
- Duration: 72 hrs
- Concentrations: No data available
B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: No data available
- Evaluation (hr after challenge): No data available - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- No. with + reactions:
- 1
- Total no. in group:
- 1
- Clinical observations:
- Woman had a positive reaction. A lymphohistiocytic perivascular infiltrate in the dermis was observe Clinical chemistry: an increased number of Langerhans cells in the dermis and epidermis cells were observed.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. No with. + reactions: 1.0. Total no. in groups: 1.0. Clinical observations: Woman had a positive reaction. A lymphohistiocytic perivascular infiltrate in the dermis was observe Clinical chemistry: an increased number of Langerhans cells in the dermis and epidermis cells were observed. .
Any other information on results incl. tables
other details not known
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The benzylparaben (94-18-8) was found to be sensitizing to woman after patch test.
- Executive summary:
A 43 year woman which is already had 3-year history of relapsing nodules and small plaques on her trunk, after 7 years later she again showed multiple nodules and plaques on the trunk and erythema and scaling on the face. Patch test was performed and observed for 72 hrs for paraben mix. Positive reaction was observed for benzylparaben.
Therefore, benzylparaben (94-18-8) was found to be sensitizing to woman after patch test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.