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EC number: 210-719-3 | CAS number: 622-08-2
- 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
The skin sensitisation potential of the test item Benzyl Glyco (Assay > 99%) was assessed according to in vitro skin sensitisation guideline OECD 442E.
The study was carried out on the human cell line THP-1, in two indipendent runs. Celles were exposed to 5 different concentrations of the test chemical fro 24h. CD54/CD86 over-expression, strictly related to the sensitizing potential of the test substance, was assessed by flow cytometry.
Under the test conditions the test substance resulted NEGATIVE (non sensitizer) up to the maximal tested concentration of 1000 mcl/mL.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 442E
- Version / remarks:
- 2018
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- activation of dendritic cells
- Details on the study design:
- Cell Line: THP-1
Monocytes form peripheral blood
Culture conditions: 37°C +/- 1 °C, 5% CO2, 90+/- 10% relative humidity
Culture medium: RPMI enriched with 10% heat-inactivated Fetal Bovine Serum (FBS), 2 mM L-Glutamine, 0.05 mM 2-mercaptoethanol, 1% penicillin/streptomycin solution
The cells are stored as frozen stocks in liquid nitrogen.
A new batch of THP-1 cell stored in liquid nitrogen was thawed at least 2 weeks prior to start with the test. After thawing, the batch of cells that was emp4loyed in the assay was monitored for the absences of mycoplasma applying yje procedure described in SOP 80. Cells can be propagated up to 2 months after thawing.
h-CLAT is an in vitro method proposed to address the thord key event (dendritic cella ctiviation) of the skin sensitization adverse outcome pathway (AOP) by quantifing changes in the ezpression of cell surface markers associated with the process of activiation of dendrtic cells (i.e. CD54 and CD86) in the human leukemia cell line THP-1, following exposure to sensitizers. The measured expression levels of CD54 and CD86 cell surface markers are the used for supporting the discrimination between skin sensitizers and non-sensitiziers.
THP-1 cells were esposed to the test chemical for 24h and chenages in CD54 and CD86 expression levels were measured by flow cytometric following cell staining with fluorescein isothiocyanate (FITC)-labeled antibodies. In parallel cytotoxity measurement was conducted to assess whether up-regulation of surface marker expression occus at sub-cytotoxic concentrations.
The test was divided in 4 phases:
1) reactivity check
2) pre-feasibility test
3) dose finding assay
4) CD54/CD86 expression assay
CONTROLS
Negative control
- Substance: NC+DMSO culture medium with DMS
Solvent control for positive control
- Substance: DMSO
Positive control
- Substance: DNCB and NiSO 6H2O
TEST CONCENTRATIONS
The final concentration of the test substance in the test was the 1:2 dilution (1000 mcl/mL)
AQUISITION
Expression of cell surface antigen was analysed by flow cytometry. The Excitation and Emission wavelenght of CytoFLEX (Beckman Coulter) are:
Excitation wavelenght: 480 nm
Emission wavelenght: for FITC 525/40 nm; for PI 610/20 nm
DATA ANALYSIS
Collected data were analyzed with Kaluza Flow Cytometry analysis software.
EC200 and EC150 determination
For test substance to be considered sensitizers 2 effective concentrations (EC values) EC 200 for CD54 and EC150 for CD86 were aslo calculated. These values indicate the concentrations at which the test substance induces a RFI of 200 (CD54) or 150 (CD86).
When RFI of CD54 is >= 200% at any test dose contemporary showing cell viability > 50%, in the two indipendent runs , AND/OR if the RFI of CD86 is >= 150% at any tested dose contemporary showing cell viability > 50% in the two independent runs, the test chemical is considered POSITIVE (sensitizer); otherwise it is considered NEGATIVE (non-sensitizer). If the two runs are not concordant for at least one of the markers /CD54 or CD86), it is necessary to perform an additional run and conclusions are based on the majority result of the three individual runs. - Key result
- Run / experiment:
- other: first run
- Parameter:
- other: relative fluorescence intensity of CD54 (%)
- Value:
- 200
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: second run
- Parameter:
- other: relative fluorescence intensity of CD54 (%)
- Value:
- 200
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: first run
- Parameter:
- other: relative fluorescence intensity of CD86 (%)
- Value:
- 150
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: second run
- Parameter:
- other: relative fluorescence intensity of CD86 (%)
- Value:
- 150
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to test conditions, the test item is to be considered NEGATIVE (non-sensitizer) up to the concentration 1000 mcl/mL.
Since 1000 mcl/mL in DMSO (highest soluble concentration) was used as the maximal test concentration in the CD54/CD86 expression assay, negative result is acceptable even if the cell viability was above 90% at the highest concentration. A third run was not necessary.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Based on the results , Benzyl Glycol is not considered as a skin sensitizer.
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