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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 608-408-6 | CAS number: 29736-24-1
- 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
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Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1st December 1997 - July 3, 1998
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- in vivo data was already available
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- none
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- INDUCTION EXPOSURE:
Day 0: Induction by intradermal injection: Two pairs of intradermal injections of 0.1 ml each were administered to each animal.
Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
Dose group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA
Day 7: Induction by dermal application
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
CHALLENGE EXPOSURE:
Day 21: Challenge by dermal application: each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- INDUCTION EXPOSURE:
Day 0: Induction by intradermal injection: Two pairs of intradermal injections of 0.1 ml each were administered to each animal.
Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
Dose group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA
Day 7: Induction by dermal application
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
CHALLENGE EXPOSURE:
Day 21: Challenge by dermal application: each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
- No. of animals per dose:
- 10 males (test group)
5 males (control group)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75:25 mixture (w/w) of test article and white vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% benzocaine in liquid paraffine
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- skin reactoin
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the classification system for skin reactions of the EEC Directive 93/21 the test item has no skin sensitisation effect.
- Executive summary:
Guidance on information requirements and chemical safety assessment, Chapter R.7a, p.279: Endpoint specific
guidance, Guidance for the implementation of REACH,May 2008, ECHA: Read-across from structurally related substances can be used to classify the substance as not sensitising to the skin (Integrated testing strategy (ITS) for skin sensitisation).
Important considerations for the read-across approach is:
· BLANCOLEN HP has similar physico-chemical properties likeBRUGGOLITE FF6
· BLANCOLEN HP is a constituent of BRUGGOLITE FF6
· The structural similarities between the two chemicals.
The weight of evidence analysis (taking into account the evaluation of skin sensitisation of BRUGGOLITE FF6 which is not a skin sensitisizer), following ITS, indicates that the test item is devoid of any skin irritation.
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.
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