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EC number: 242-424-0 | CAS number: 18559-94-9
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Salbutamol
- EC Number:
- 242-424-0
- EC Name:
- Salbutamol
- Cas Number:
- 18559-94-9
- Molecular formula:
- C13H21NO3
- IUPAC Name:
- 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Test item was examined in the main test at concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v).The test item was weighed and formulations prepared daily on a weight: volume basis in a final volume of 1 mL using volumetric vials and mechanical agitation.
- No. of animals per dose:
- 4 animals/treatment group.
28 animals/main test. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Value:
- 4.3
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 1% w/v
- Parameter:
- SI
- Value:
- 1.9
- Test group / Remarks:
- 2.5% w/v
- Parameter:
- SI
- Value:
- 3.4
- Test group / Remarks:
- 5% w/v
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 10% w/v
Any other information on results incl. tables
No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group.
No signs of irritation or any other local effect were observed at the treatment site (ears) in any treatment group.
Significant lymphoproliferative response (SI ≥ 3) compared to the relevant vehicle control (DMSO) was noted for Salbutamol base at 10 % and 5 % (w/v) test concentrations. No significantly increased lymphoproliferation was observed in the 2.5 % and 1 % (w/v) dose groups. The observed stimulation index values were 3.5, 3.4, 1.9 and 0.9 at test item concentrations of 10 %, 5 %, 2.5 % or 1 % (w/v), respectively. The response was considered dose-related although no statistical significance was observed (p = 0.14, r = 0.86, evaluated by linear regression using the calculated SI values).
According to evaluation criteria of the relevant guidelines, the significantly increased lymphoproliferation (indicated by an SI ≥ 3) observed at the maximum feasible concentration of 10 % (w/v, based on solubility) and also at concentration of 5 % (w/v) and the dose-related response are considered evidence that Salbutamol base is a skin sensitizer.
Chemicals can be classified according to their relative skin-sensitization potency using EC3 value (dose calculated to induce a stimulation index of 3) calculated by linear interpolation using data points lying immediately above and below the SI value of 3 on the LLNA dose-response curve according to published method. The calculated EC3 value for the test item was 4.3 % (w/v) in this LLNA. Using this value Salbutamol base can be ranked among moderate skin sensitizers according to the published data for classification of contact allergens.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the conditions of the present assay, Salbutamol base tested at the maximum feasible concentration of 10 % (w/v, based on solubility) and at concentrations of 5 %, 2.5 % and 1 % (w/v) as formulations in a suitable vehicle (DMSO) was shown to have skin sensitization potential (skin-sensitizer) in the Local Lymph Node Assay.
Based on the EC3 value of 4.3% (w/v) calculated using the dose-response curve Salbutamol base was classified as a moderate skin sensitizer in this LLNA according to the published data. - Executive summary:
The aim of this study was to evaluate the skin sensitization potential of Salbutamol base following dermal exposure in the Local Lymph Node Assay.
A formulation evaluation and a Dose Range Finding test (DRF) were performed to find an appropriate vehicle and the maximum applicable concentration according to the relevant guidelines. Based on the results the test item was formulated in Dimethyl sulfoxide (DMSO) in the LLNA. The maximum achievable concentration (based on solubility) was 10 % (w/v). According to results of the DRF, where no adverse effects (systemic or local) were observed up to this maximum concentration, the test item was examined in the main test as 10 %, 5 %, 2.5 % or 1 % (w/v) formulations (apparently solutions) in DMSO. Appropriate positive control (α-Hexylcinnamaldehyde, HCA), furthermore two negative control groups dosed with the vehicles of the test and positive control groups, respectively, were employed.
The positive control item [25 % (w/v) HCA in Acetone: Olive oil 4:1 (v/v) mixture (AOO)] induced significant stimulation over the relevant control (SI = 5.2) thus confirming the validity of the assay.
No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation or any other local effect were observed at the treatment site (ears) in any treatment group.
Significant lymphoproliferative response (SI ≥ 3) compared to the relevant vehicle control (DMSO) was noted for Salbutamol base at 10 % and 5 % (w/v) test concentrations. No significantly increased lymphoproliferation was observed in the 2.5 % and 1 % (w/v) dose groups. The observed stimulation index values were 3.5, 3.4, 1.9 and 0.9 at test item concentrations of 10 %, 5 %, 2.5 % or 1 % (w/v), respectively. The response was considered dose-related although no statistical significance was observed (p = 0.14, r = 0.86, evaluated by linear regression using the calculated SI values).
According to evaluation criteria of the relevant guidelines, the significantly increased lymphoproliferation (indicated by an SI ≥ 3) observed at the maximum feasible concentration of 10 % (w/v, based on solubility) and also at concentration of 5 % (w/v) and the dose-related response are considered evidence that Salbutamol base is a skin sensitizer.
Chemicals can be classified according to their relative skin-sensitization potency using EC3 value (dose calculated to induce a stimulation index of 3) calculated by linear interpolation using data points lying immediately above and below the SI value of 3 on the LLNA dose-response curve according to published method. The calculated EC3 value for the test item was 4.3 % (w/v) in this LLNA. Using this value Salbutamol base can be ranked among moderate skin sensitizers according to the published data for classification of contact allergens.
Under the conditions of the present assay, Salbutamol base tested at the maximum feasible concentration of 10 % (w/v, based on solubility) and at concentrations of 5 %, 2.5 % and 1 % (w/v) as formulations in a suitable vehicle (DMSO) was shown to have skin sensitization potential (skin-sensitizer) in the Local Lymph Node Assay.
Based on the EC3 value of 4.3% (w/v) calculated using the dose-response curve Salbutamol base was classified as a moderate skin sensitizer in this LLNA according to the published data.
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