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Registration Dossier
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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: - | CAS number: -
- 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
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:
- 2nd August 2017 - 1st September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was initially conducted for R&D purposes. However, as a valid skin sensitization test already existed it was considered unethical to re-run the same study to a different method
Test material
- Test material form:
- liquid
- Details on test material:
- - Appearance: yellow liquid
- Storage conditions of test material: Room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Prior to use, all animals were acclimated for at least 5 days. Animals were individually housed in wire mesh suspension cages. The animals were maintained on a 12 hour cycle light controlled room, at a temperature of 64-79 F and a relative humidity of 30-70%
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- six hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 75%
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 75%
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- 0.4 ml of the test item at 100% concentration was added directly yo Hilltop chambers and applied to the clipped left shoulder of twenty albino guinea pigs. The chambers were secured in place with micropore and Kendall adhesive tape for 6 hours. Two additional doses were conducted following the same procedure, at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of the test material at 75% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 houts are initation of the primary challenge application.
- Challenge controls:
- six naive control animals received only the primary challenge dose, at a concentration of 75%
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following primary challenge of the test article at 75% concentration, the incidence of grade 1 responses or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
- Executive summary:
The test substance was evaluated for sensitization potential by applying 0.4 mL at a 100% concentration directly into Hilltop chmabers and applying them to the clipped left shoulder of twenty albino guinea pigs. The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chmabers were secured with Micropore and Kendall adhesive tape. Approximatley 6 hours later, the tape and chambers were removed. Two additional indction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primay challenge dose (6 hour contact) of the test material at 75% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 houts after initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 75% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.
Follwoing primary challenge at 75% concentration, the incidene of grade 1 responses or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these resposnes were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
Under the classification criteria set forth under GHS, the test substance is not considered to be a skin sensitizer.
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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