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EC number: 220-180-6 | CAS number: 2654-57-1
- 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
Endpoint summary
Administrative data
Description of key information
In a GPMT test performed according to the method of Magnussen -Kligman, 20 female Dunkin- Hartley guinea-pigs were induced intradermally and epicutaneously with 5 and 50% of the substance respectively. 20 control females received the same treatment with the vehicle (coconut oil). After 2 weeks an epicutaneous challenge was initiated at 10 and 20% of the substance in vehicle. Flanks were assessed for erythema and oedema at 24, 48 and 72 hours after challenge.
A positive result was reported in 14 of the test substance induced females. This result is indicative for sensitizing properties of the substance. Hence, the test chemical can be considered to be sensitizing to skin.
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register Vol 50 no 188, Part II, 27 September 1985
- Version / remarks:
- section 798-4100- dermal sensitisation
- Principles of method if other than guideline:
- A study as performed in guinea pigs to determine the sensitization potential of the test chemical
- GLP compliance:
- yes
- Remarks:
- QA statement and statement by study director in the report
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA test not available at the time of testing. GPMT test considered to be adequate data
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall New Church Staffordshire England
- Females (if applicable) nulliparous and non-pregnant; not specified
- Age at study initiation: no data
- Weight at study initiation: 385-488 g
- Housing: cages with wire mesh floors
- Diet: Vitamin C enriched Guinea-Pig Diet F.D.I.. ad libitum
- Water; tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C):ca 21 °C
- Humidity (%): 30-70%
- Air changes (per hr): ca 15/hr
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D
- Concentration / amount:
- 5%
- Day(s)/duration:
- NA
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D
- Concentration / amount:
- 50%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D
- Concentration / amount:
- 10 and 20%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 treatment and 20 control
- Details on study design:
- RANGE FINDING TESTS: PIT was performed but not reported in the study report. Concentrations were chosen based on the outcome of this test
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 48 hours epicutaneous
- Test groups: 20 females
- Control group: 20 females (vehicle)
- Site: scapular region
- Concentrations: 5% intradermal, 50% epicutaneous
intradermal :according to the guideline
epucutaneous: one week after intradermal challenge
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after induction
- Exposure period: 24 hours
- Test groups: 20 females
- Control group: 20 females
- Site: 2 patches were applied to the flank saturated with 10% or 20% substance in the vehicle
- Evaluation (hr after challenge): 24, 48 and 72 hours
- Challenge controls:
- yes
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: slight erythema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: very slight erythema and incidental oedema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 and 20%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: slight erythema at 20%
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: slight erythema and oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: well defined etythema and oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 and 20%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: slight erythema in 0 animals at 10% and 4 animals at 20%
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: well defined erythema, in an additional 12 animals slight effects were seen
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- well defines erythema and slight oedema
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10 and 20%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: very slight eryhema in 0 amimals at 10% and in 4 animals at 20%
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- A positive result was reported in 14 of the test substance induced females. This result was indicative for sensitizing properties of the substance.
Hence, the test chemical can be considered to be sensitizing to skin. - Executive summary:
In a GPMT test performed according to the method of Magnussen -Kligman, 20 female Dunkin- Hartley guinea-pigs were induced intradermally and epicutaneously with 5 and 50% of the substance respectively. 20 control females received the same treatment with the vehicle (coconut oil). After 2 weeks an epicutaneous challenge was initiated at 10 and 20% of the substance in vehicle. Flanks were assessed for erythema and oedema at 24, 48 and 72 hours after challenge.
A positive result was reported in 14 of the test substance induced females. This result is indicative for sensitizing properties of the substance. Hence, the test chemical can be considered to be sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a GPMT test performed according to the method of Magnussen -Kligman, 20 female Dunkin- Hartley guinea-pigs were induced intradermally and epicutaneously with 5 and 50% of the substance respectively. 20 control females received the same treatment with the vehicle (coconut oil). After 2 weeks an epicutaneous challenge was initiated at 10 and 20% of the substance in vehicle. Flanks were assessed for erythema and oedema at 24, 48 and 72 hours after challenge.
A positive result was reported in 14 of the test substance induced females. This result is indicative for sensitizing properties of the substance. Hence, the test chemical can be considered to be sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available result for the test chemical indicates that the test chemical has the potential to cause sensitization to skin. Hence, it can be considered to be a skin sensitizer and classified under the category "Skin Sensitizer 1" as per CLP Regulation.
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.
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