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EC number: 237-222-4 | CAS number: 13701-59-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 August - 1 October, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No information on the purity of the test material. It seems that the test was conducted using an adaptation of the method of Ritz and Buehler. Historical control data was provided after the study was carried out.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- The potential of Busan 11-M1, at a concentration of 75% (W/V) in distilled water, to produce delayed contact hypersensitivity in Guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Adaptation of the method of Ritz and Buehler
Test material
- Reference substance name:
- Busan 11-M1
- IUPAC Name:
- Busan 11-M1
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Busan 11-M1
- Substance type: No data
- Physical state: White powder
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 8-11866
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Age at study initiation: young adult
- Weight at study initiation: 329 - 526 g
- Housing: Individually in wire mexh suspension cages
- Diet (e.g. ad libitum): Purina Guinea pig Chow (or comparable) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 25/08/1988 To: 01/10/1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Pilot 1: 0.5, 1.0, 2.5, 5.0, 10, 25, 50, 75 % (W/V) in distilled water
Induction: 75 % (W/V) in distilled water
Challenge: 75 % (W/V) in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Pilot 1: 0.5, 1.0, 2.5, 5.0, 10, 25, 50, 75 % (W/V) in distilled water
Induction: 75 % (W/V) in distilled water
Challenge: 75 % (W/V) in distilled water
- No. of animals per dose:
- Primary irritation: 4/sex/dose
Test (induction of sensitization and primary challenge): 10/sex/dose
Positive control: 5/sex/dose - Details on study design:
- RANGE FINDING TESTS:
Sites are prepared by clipping the hair on the day before application of the test article. An appropriate volume of test article is applied into the selected patch system. The animal is placed into the restrainer and the patches applied to the clipped skin surface. The patches are occluded with a rubber dental dam pulled taut and fastened to the bottom m of the restrainer with clips. The restrainer is adjusted to minimise movement of the animal during exposure. 6 hours later the dental dam and patches are removed and the animal is removed from the restrainer and replaced in its cage. Excess material may be removed. On the day following exposure, the animals are depilated and scored.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 group male and female 75 % (W/V):
- Control group: No induction on control group
- Site: left sholder
- Frequency of applications: weekly
- Duration: 6 hours
- Concentrations: 75 % (W/V) in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: 1 on
- Day(s) of challenge: 2 weeks after induction
- Exposure period: 6 hours
- Test groups: 1 group male and female 75 % (W/V)
- Control group: 1 group male and female 75 % (W/V)
- Site:not previously exposed
- Concentrations: 75 % (W/V) in distilled water
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Ten animals (naive control) which have never been exposed to the test article are treated with the same concetnration as the test animals.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-Dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 % (W/V)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- incidence of +/- reactions comparable to controls
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 % (W/V). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: incidence of +/- reactions comparable to controls.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 % (W/V)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- some +/- reactions observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 % (W/V). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: some +/- reactions observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 % (W/V)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- incidence of +/- reactions comparable to controls
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 % (W/V). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: incidence of +/- reactions comparable to controls.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 % (W/V)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- some +/- reactions observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 % (W/V). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: some +/- reactions observed.
Any other information on results incl. tables
No further data
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Following primary challenge there were no grades of 1 produced in the test or control animals. The incidence of grade ± responses in the test group, was compared to that of the naive control group. The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group and this indicated that sensitisation had not been induced. Therefore no classification is warranted for sensitisation.
- Executive summary:
In a study conducted by Kreuzmann (1988), Guinea pigs were induced by applying patches of 75% (w/v) of the test substance, Busan 11-M1, to clipped exposure sites on the left shoulders of the animals. The 6 hour exposures were carried out weekly for 3 weeks. Two weeks later patches of the test substance were applied in the same manner for an exposure period of 6 hours to the test group and a naive control group at a concentration of 75% (w/v) of Busan 11-M1. At the test concentration used in this study, the test substance did not elicit allergenic responses and as such, is not considered to be a potential skin sensitiser. Based on these results, the test substance does not warrant classification for skin sensitisation in accordance with Regulation EC No. 1272/2008.
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