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EC number: 431-090-3 | CAS number: 190085-41-7
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 22 December 2008 to 30 January 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Principles of method if other than guideline:
- Although not stated, the procedure used was essentially that of Draize (Procedures for the appraisal of the toxicity of chemicals in foods, drugs, and cosmetics. VIII. Dermal toxicity, Food Drug Cosmetic Law J. 10:722-731, 1955).
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- patch test
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Participants:
Sixty-one (61) male and female ranging in age from 17 to 73 years of age. Fifty-three (53) subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Inclusion Criteria:
The following criteria applied to study participants: male and female, age 16 or older; an absence of any visible skin disease which might confuse the study results; prohibition on the use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation; completion of medical history forms and informed consent forms; considered reliable and capable of following directions.
Exclusion Criteria:
The following applied: ill health; someone under a doctor's care and taking medication that might influence the outcome of the study; pregnant or nursing females; a history of adverse reactions to cosmetics or other personal care products. - Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- No. of animals per dose:
- 53 participants completed the study
- Details on study design:
- Test Material Preparation:
The test material was prepared as a 25% dilution in corn oil.
Application Area:
The upper back between the scapulae served as the treatment area. Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to a 1 inch x 1 inch absorbent pad portion of a clear adhesive bandage. This was then applied to the appropriate treatment site to form a semi-occlusive patch.
Induction Phase:
Patches were applied 3 times weekly (e.g., Monday, Wednesday and Friday) for a total of 9 applications. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent induction patches at home, twenty-four hours after application. Site evaluations were performed prior to re-application.
Challenge Phase:
Approximately 2 weeks after induction patch applications, a challenge patch was applied to a virgin (untreated) site adjacent to the original induction patch applications. The challenge patches were removed and the sites scored at the clinic 24 and 72 hours after applications. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- No positive reactions for irritation or allergic contact sensitization.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 53.0. Clinical observations: No positive reactions for irritation or allergic contact sensitization..
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- No positive reactions for irritation or allergic contact sensitizaiton.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 53.0. Clinical observations: No positive reactions for irritation or allergic contact sensitizaiton..
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, HallBrite BHB did not indicate a potential for dermal irritation or allergic contact sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a procedure essentially that of Draize (1955), a human Repeated Insult Patch Test (RIPT) was completed on 52 male and female volunteers. In an induction phase, approximately 0.2 mL aliquots of the undiluted test substance was applied 3 times weekly for a total of 9 applications to the upper backs between the scapulae using an absorbent pad and clear adhesive bandage. Pads were removed after 24 hours. Approximately 2 weeks following the induction phase, challenge patches were applied to untreated sites on the backs of volunteers and these removed and the sites scored after 24 and 72 hours. There were no positive skin reactions recorded in this study. In a similar RIPT study employing 53 male and female volunteers, 25% test substance in corn oil was used for induction and challenge phases of the study. As in the previous study, there were no positive skin responses recorded.
Skin sensitization studies were conducted on the test substance using the method of Magnusson and Kligman (OECD 406) at applied concentrations of 50 and 100%. The vehicle employed was 70% ethanol with a 5% concentration used for intradermal induction and a 100% topical induction concentration. Challenge concentrations were 50 and 100%. One of ten animals challenged at the 50% concentration exhibited a clear dermal response (score of 1 or greater) with all other animals showing responses less than 1. None of the animals challenged at 100% exhibited a dermal response. The test substance was not deemed a skin sensitizer under the conditions of this study. In essentially a repeat of this study, there were no positive skin responses in animals challenged at either 50 or 100%. In this latter study, a positive control group treated with the known skin sensitizer HCA gave a clear positive skin response.
Migrated from Short description of key information:
In two well conducted human Repeated Insult Patch Tests (RIPT) following accepted GLP standards, the test substance failed to cause skin sensitization at applied challenge concentrations of either 25% or 100%.
Justification for selection of skin sensitisation endpoint:
In two well conducted human Repeated Insult Patch Tests (RIPT) following accepted GLP standards, the test substance failed to cause skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on consistent and negative findings from both human RIPT studies and guinea pig maximization studies, the subject material would not be rated for skin sensitization under either the EU Directive 67/548/EEC or under the EU CLP (Regulation (EC) 1272/2008).
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