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Diss Factsheets
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EC number: 223-445-4 | CAS number: 3896-11-5
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Method follows standard procedure for patch testing in humans
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The test was performed on the skin of human volunteers (59). Patches were applied on alternate days, 3 times per week for 24 hours each (total of 15 applications). After removal of the last application preceeding the challenge, the sites were examined immediately and once daily for at least two days. The challenge was applied to the original contact site after 14 days of no contact with test material. The challenge application was terminated after 24 hours. The sites were examined for immediate reactions which, if present, were graded and recorded. These sites were re-examined after 24 and 48 hours later for delayed reactions.
- GLP compliance:
- no
Test material
- Reference substance name:
- Bumetrizole
- EC Number:
- 223-445-4
- EC Name:
- Bumetrizole
- Cas Number:
- 3896-11-5
- Molecular formula:
- C17 H18 Cl N3 O
- IUPAC Name:
- 2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
- Test material form:
- solid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 59
- Sex: 26 male/ 33 female - Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Lintine gauze, covered with polypropylene, the edges of which were fixed to the skin with tape to seal the contents.
- Vehicle / solvent: Dimethylphthalate
- Concentrations: 0.3 %
- Volume applied: no data
- Testing/scoring schedule: Induction - days 0-21; challenge day 35; examination days 36, 37, 38
- Removal of test substance: yes
EXAMINATIONS
- Grading/Scoring system:
0 = No visible irritation, or no difference from surrounding untreated skin
1+ = Erythema confined to contact site and barely exceeding that of untreated skin
2+ = Erythema confined to the contact site and definitely exceeding that of untreated skin
3+ = Erythema exceeding that of untreated skin, with some edema; both confined to the contact site
4+ = Erythema and edema with one or more complications such as: extension beyond margins of contact area, vesiculation and ulceration.
CRITERIA FOR PRIMARY IRRITATION
a. A response was produced within any initial 24 hour contact period.
b. The response persisted for a minimum of 30 minutes after removal of the test material.
c. The magnitude of the response did not increase after removal of the test material.
d. The response was confined to the contact site.
e. Subjective sensations, if present, consisted mainly of pain components.
CRITERIA FOR FATIGUING
a. No response was produced by the first application.
b. Response consisting of some degree of erythema was elicited as a result of the second or later application in the series.
c. The response persisted for a minimum of 30 minutes following removal of the test material.
d. The magnitude of the response did not increase after the removal of the test material.
e. The response was confined to the contact site.
f. Subjective sensations, if present, consisted mainly of pain components.
CRITERIA FOR SENSITIZATION
- Presumptive Criteria
a. Initial applications may or may not have elicited responses typical of primary irritation or fatiguing action.
b. Some time after the initial application, a response which may not have been visible immediately upon removal of the test material, did appear. This reponse increased in magnitude and may not have reached a maximum until 36-48 hours after initiation of contact.
c. Erythema was usually accompanied by edema. Vesiculation and ulceration were possible complications.
d. The response may have extended beyond the limits of the contact site.
e. Subjective sensation of itching accompanied the lesions.
- Definitive Criteria
a. Previous contact sites, heretofore quiescent, manifested erythema, edema and itching concurrent with the eruption at the site of most recent contact.
b. After initial hypersensitive reaction had been elicited, any skin site contacted thereafter responded with a reaction of a similar order of magnitude on first contact. The validity of this criteria is predicated on contact of sufficient duration to allow a supra-threshold quantity of sensitizer to penetrate the skin. For purposes of consistency, a contact period of 24 hours was used in this study.
Results and discussion
- Results of examinations:
- SYMPTOMS
- One male with slight erythema after third application during the induction phase, which did not reoccur after subsequent applications. No effects observed during the challenge phase.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 59
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the test substance is not sensitising in humans.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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