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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- 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 - Route:
- other: No data available
- Vehicle:
- no data
- Concentration / amount:
- No data available
- 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
- Positive control results:
- No data available
- 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. .
- 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.
Reference
other details not known
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitization:
Various studies were reviewed and the effect of the test compound onSkin sensitization. These are summarized as follows:
The benzylparaben (94-18-8) was found to be sensitizing (Dermal contact dermatitis from benzylparaben, 1989) to woman after patch test. 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.
The patch test was performed to 50 year old human man as he is developed relapsing tinea of the anagenital region and the neighboring thighs. He was patch tested with the European standard series. After 2 to 3 days of observation positive result was observed for patch test.Therefore, benzylparaben (94-18-8) was found to be sensitizing to human.
In Final Report on the Safety Assessment of Benzylparaben, 963. The preliminary tests were conducted using routine patch tests with a mixture comprised of 10% methylparaben, 2% ethylparaben, and 2% propylparaben in equal parts Aquaphor and water.Fifteen cases positive to this mixture [preliminary tests] were assayed for Benzylparaben sensitivity 7/15 were sensitive to both 1 and 5% Benzylparaben solutionsBenzylparaben was found to be sensitizing to eczemateous patients tested for sensitivity to parabens
The study report REPORTS of the Scientific Committee on Cosmetology (sixth series), 1987 indicates Benzylparaben was found to be sensitizing to 2 patients of the 4 tested for sensitivity to five parabens.
Among 2000 patients tested in a hospital in a year, 4 were found sensitive to parabens. These 4 patients were tested with each of the 5 parabens, namely methyl, ethyl, propyl, butyl and benzyl. 2 patients were found to react to benzyl paraben.Benzylparaben was found to be sensitizing to 2 patients of the 4 tested for sensitivity to five parabens.
According to new CLP regulation classification criteria and based on the values of skin sensitization, it is concluded that the substance benzylparaben (CAS No 94-18-8) is classified for skin sensitization.
Migrated from Short description of key information:
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
Justification for selection of skin sensitisation endpoint:
The benzylparaben (94-18-8) was found to be sensitizing to woman after patch test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
In in-vivo patch-test in human benzylparaben (CAS No 94-18-8) produced sensitization reactions in all humen tested. As per CLP classification, the test material benzylparaben classifies as a skin sensitisation.
Justification for classification or non-classification
Benzylparaben is classified as a skin sensitisation.
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