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EC number: 444-010-7 | CAS number: 82654-98-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: ECHA provided robust study summary
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Maximisation test).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Test met the previous requirements before the entry into force of REACH. The test is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
Test material
- Reference substance name:
- -
- EC Number:
- 444-010-7
- EC Name:
- -
- Cas Number:
- 82654-98-6
- Molecular formula:
- C12H18O3
- IUPAC Name:
- 4-(butoxymethyl)-2-methoxyphenol
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan strain, albino guinea pig
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 5% concentration
- Day(s)/duration:
- 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 2
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- Maximum concentration not causing irritating effects in preliminary test: 100 %
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Yellow staining in all animals was observed. This staining did not hamper the scoring of the skin reactions.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Yellow staining in one animal was observed. This staining did not hamper the scoring of the skin reactions.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Yellow staining in one animal was observed. This staining did not hamper the scoring of the skin reactions.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Signs of irritation during induction: Mild to moderate erythema was seen in all animals.
Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of sensitisation at each
challenge concentration: Six
Other observations: Bodyweight gains of animals in the test group, between Day 0 and Day 24, were comparable to those in the control group. Yellow staining was observed at the test substance treated skin sites, 24 and/or 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The skin reactions observed in response to a 100% test substance concentration in six (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 60 per cent.
- Executive summary:
The study to assess the Contact Hypersensitivity to the test item in the Albino Guinea Pig (Maximisation Test) was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation". Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermal injected with a 5% concentration and epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). In the challenge phase, skin reactions of grade 1 were observed in six experimental animals in response to the 100% test substance concentration. No skin reactions were evident in the control animals. Yellow staining was observed at the test substance treated skin sites, 24 and/or 48 hours after challenge. This staining did not hamper the scoring of the skin reactions. The skin reactions observed in response to a 100% test substance concentration in six (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 60 per cent.
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