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EC number: 210-259-3 | CAS number: 611-20-1
- 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:
- key study
- Study period:
- 2008-01-29 to 2008-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-hydroxybenzonitrile
- IUPAC Name:
- 2-hydroxybenzonitrile
- Reference substance name:
- Salicylonitrile
- EC Number:
- 210-259-3
- EC Name:
- Salicylonitrile
- Cas Number:
- 611-20-1
- Molecular formula:
- C7H5NO
- IUPAC Name:
- 2-hydroxybenzonitrile
- Details on test material:
- TEST MATERIAL
- Name of test material (as cited in study report): 2-hydroxybenzonitrile
- Substance type: pure test substance, recrystallised 2-cyanophenol
- Physical state: solid, yellowish (beige) crystalline powder
- Melting range: 95.4°C
- Stability under test conditions: not determined
- Storage condition of test material: room temperature, stable
RADIOLABEL
- 3H-methyl thymidine
- 80 microcurie / mL (3H, tritium)
- radiochemical purity: 96%
- thymine content: 0.9%
- specific activity of stock solution: 2.0 Ci/mmol
- radioactive concentration of stock solution: 1 mCi/mL
- amount of stock solution: 1.296 mL
- diluted with phosphate-buffered saline (PBS), 14.904 mL
- dose per animal: 20 microcurie
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 19.0 - 23.0 g
- Housing: optimal hygienic conditions (OHC), single caging in Makrolon type II cages
- Diet: ad libitum, Ssniff Maintenance diet for rats and mice R/M-H (item V1534-3)
- Water: communal drinking water from Makrolon bottles, ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 (continuous monitoring)
- Humidity (%): 30 - 70% (continuous monitoring)
- Air changes (per hr): not reported (OHC)
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2008-01-29 To: 2008-02-05
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Remarks:
- DMF allows highest test substance concentration
- Concentration:
- 25%, 50%, 64.8% (w/w),
equal to 37.5, 75, 97.2 mg test substance / animal - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 64.8 % (highest solubility found in any of the guideline-recommended vehicles)
- Irritation: Range finding study with 2 animals / concentration (64.8% and 50% w/w, applied 3 times on consecutive days): no systemic toxicity, no excessive local skin irritation, nor important increase in ear thickness
- Lymph node proliferation response: Concurrent positive control with 25% hexyl cinnamic aldehyde in acetone/olive oil proves the sensitivity of the strain of animals (main study).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node assay LLNA
- Criteria used to consider a positive response: induction of a 3-fold or greater increase in 3H-methyl thymidine incorporation in lymph node cells, relative to control lymph nodes, together with the consideration of dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
25 µl of the test compound solution in DMF was administered epicutaneously to the dorsal surface of each ear of each mouse. The application was repeated on days 2 and 3. On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Approximately five hours later, the draining auricular lymph node of each ear was rapidly excised into PBS; the lymph nodes of each group were pooled. A single cell suspension of lymph node cells was prepared by gentle mechanical disaggregation through a 70 micrometer cell strainer. The cell suspension was centrifuged (4°C, max. 200 g, 10 min) and washed twice with PBS. Cell macromolecules were precipitated with 5% trichloroacetic acid (TCA) at 4 °C overnight. Each precipitate was pelleted by centrifugation (as above) and resuspended in 1 ml TCA.
Suspensions were transferred to 10 mL scintillation cocktail, and 3H-TdR incorporation was determined with a beta-scintillation counter.
BODY WEIGHT:
- recorded on days 1 and 6
SKIN REACTIONS:
- application sites were visually checked for local irritations once daily (days 1-6) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Stimulation index (SI) = disintegrations per minute (dpm) in the test group (pooled) / dpm in the negative control group (pooled)
dpm corrected by subtraction of background
Results and discussion
- Positive control results:
- SI of positive control group (hexyl cinnamic aldehyde) = 16.2
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 4.1
- Test group / Remarks:
- Group A (low dose; 25% (w/w))
- Remarks on result:
- other: group K (negative control): 1 group P (positive control): 16.2
- Parameter:
- SI
- Value:
- 9.1
- Test group / Remarks:
- Group B (mid dose; 50% (w/w))
- Parameter:
- SI
- Value:
- 12.5
- Test group / Remarks:
- Group C (high dose; 64.8% (w/w))
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: group K (negative control): 2752 group A (low dose): 11186 group B (mid dose): 25022 group C (high dose): 34377 group P (positive control): 44455
Any other information on results incl. tables
BODY WEIGHT DEVELOPMENT:
- Weights and weight gains were within the expected range for this strain, sex, and age.
- Slight body weight losses were noted in animals of all groups, including negative and positive controls.
SYMPTOMS:
- No clinical signs in any animal.
SKIN REACTIONS:
- No local irritations in the negative control group and the three dose groups.
- Slight erythema of the application site in the positive control (day 3).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The substance is considered to be sensitising. The study is considered to be relevant and reliable.
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