Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 December 2008 to 30 January 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- 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
- Justification for non-LLNA method:
- The testing was completed on 30 January 2009. The LLNA 429 was not formally adopted by the OECD until July 2010.
Test material
- Reference substance name:
- -
- EC Number:
- 431-090-3
- EC Name:
- -
- Cas Number:
- 190085-41-7
- Molecular formula:
- C19 H30 O3
- IUPAC Name:
- 2-butyloctyl 2-hydroxybenzoate
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Participants:
Fifty-six (56) male and female subjects ranging in age from 19 to 78 years of age. Fifty-two (52) 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.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No. of animals per dose:
- 52 participants completed the study
- Details on study design:
- Test Material Preparation:
The test material was applied neat (undiluted).
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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 52
- Clinical observations:
- No positive reactions for irritation or allergic contact sensitization.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 52
- Clinical observations:
- No positive reactions for irritation or allergic contact sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material did not indicate a potential for dermal irritation or allergic contact sensitization.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.