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EC number: 203-623-8 | CAS number: 108-86-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- limited data on results (body weights, local irritation, individual data/readouts)
- Justification for type of information:
- Please refer to analogue justification provided in IUCLID section 13
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 23 July 2010
- Deviations:
- yes
- Remarks:
- limited data on results (body weights, local irritation, individual data/readouts)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Chlorobenzene
- EC Number:
- 203-628-5
- EC Name:
- Chlorobenzene
- Cas Number:
- 108-90-7
- Molecular formula:
- C6H5Cl
- IUPAC Name:
- chlorobenzene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- (CBA/CaOlaHsd and CBA/J, not further specified)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Haraln Winkelmann GmbH, Borchen, Germany or Charles River Laboratories, Sulzfeld, Germany GmbH (not further specified), Sulzfeld, Germany
- Females nulliparous and non-pregnant: Not specified
- Age at study initiation: 6-12 weeks
- Housing: Makrolon type I or II cages
- Diet: Provimi Kliba, (Kliba-Labordiät, Maus/Ratte Haltung 'GLP', SA, Kaiseraugst, Basel, Switzerland), ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100% (undiluted) (no further information available)
- No. of animals per dose:
- 6
- Details on study design:
- PRE-SCREEN TESTS:
- Ear thickness measurements: conducted in three mice exposed to a concentration of 5% in order to determine skin irritating concentrations. The resultant high concentration and two lower concentrations spaced by a factor of approximately 3 each were selected for the study (if an indication of ear skin irritation was observed, lower concentrations were used). The concentrations tested in the presented study were higher than that defined in the published harmonized minimum performance standards (PS study). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- eugenol (CAS No 97-53-0)
- mercaptobenzothiazole (CAS No 149-30-4)
- other: All substances defined as recommended reference substances for the LLNA performance standards defined in OECD TG 429 were tested in the conducted study.
- Statistics:
- The estimated concentration (EC) for the SI = 1.5 (defined for the non-radioactive evaluation method) or SI = 3 (defined for the standard radioactive LLNA procedure) was calculated by linear regression using the data points directly below and above the threshold or using the two nearest points below or above the SI. Results exceeding these cut-off SIs are considered to indicate biologically relevant signs of lymph node cell proliferation. A substance was considered a sensitizer if at least one concentration tested caused a concentration-dependent statistically significant and/or biologically relevant increase in LNCC, dpm and/or lymph node weight compared with the vehicle control.
Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The SIs of lymph node cell cound (LNCC, referred to as "non-radioactive" method, 3H-thymidine incorporation, lymph node weight (LNW) and ear weight were calculated as the ration of the test group mean values divided by those of the vehicle control group. The presence of a skin irritation reaction to topical treatment was determined by whether a greater than 20% increase in ear weight occurred.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- standard radioactive LLNA
- Value:
- >= 1.91 - <= 5.3
- Test group / Remarks:
- 25, 50 and 100%
- Remarks on result:
- other: At the highest concentration tested, increased ear weight was determined. Thus, a positive response due to irritation cannot be excluded.
- Parameter:
- SI
- Remarks:
- non-radioactive LLNA
- Value:
- >= 0.97 - <= 1.61
- Test group / Remarks:
- 25, 50 and 100%
- Remarks on result:
- other: At the highest concentration tested, increased ear weight was determined. Thus, a positive response due to irritation cannot be excluded.
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA:
EC1.5 (non-radioactive method): 79.0
EC3 CALCULATION
EC3 (radioactive method) = 45.6
Any other information on results incl. tables
Interpretation of results:
Chlorobenzene induced a dose-dependent increase in cell count (non-radioactive LLNA) and thymidine incorporation (standard LLNA). Test concentrations of 25, 50 and 100% resulted in SI values of 0.97, 1.34 and 1.61 for cell counts (non-radioactive LLNA) and SI values of 1.91, 3.23 and 5.30 for thymidine incorporation, respectively. In parallel, ear weights were increased by more than 20% at the highest test concentration, which indicates skin irritation. Considering that chlorobenzene is classified as skin irritant (category 2), a false-positive result due to skin irritation cannot be excluded for both evaluation methods. Taking further into account that 1) chlorobenzene revealed negative results in the studies considered for the recommended reference substance list cited in OECD TG 429 and 2) the dose tested are higher than that defined in the published harmonized minimum performance standards, the obtained result is considered as false-positive result. Therefore, chlorobenzene is presumed to be a non-sensitizer in the conducted LLNA test.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: Not classified
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