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Diss Factsheets
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EC number: 939-180-9 | 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Key study: Equivalent to EU method B.6. No data on GLP.
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Klimisch 2. Equivalent to EU method B.6. No data on GLP.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to EU method B.6. No data on GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Magnusson and Kligman maximisation test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 350 g
- Housing: The animals were housed individually in polypropylene cages
- Diet (e.g. ad libitum): Sterilized granules (UAR 114); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1 ºC
- Humidity (%): 50 ± 5%
- Air changes (per hr): 15 cycles/hour
- Photoperiod (hrs dark / hrs light): light - dark cycle 12 h:12 h - Route:
- intradermal and epicutaneous
- Concentration / amount:
- Nº1:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº2:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº3:
Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol)
Nº4:
Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - Route:
- epicutaneous, occlusive
- Concentration / amount:
- Nº1:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº2:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº3:
Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol)
Nº4:
Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - No. of animals per dose:
- Treatment: 20 animals
Control: 10 animals - Details on study design:
- RANGE FINDING TESTS:
The concentrations used in the main study were established in a preliminary study to determine the lowest concentrations producing low irritation for the induction phase and the highest non irritant concentrations for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1:
Three pairs of intradermal injections of 0.1 ml are given in the shoulder region.
Injection 1: the test substance in an appropriate vehicle at the selected concentration
Injection 2: a 1:1 mixture (v/v) FCA/physiological saline
Injection 3: the test substance at the selected concentration formulated in a 1:1 mixture (v/v) FCA/physiological saline.
Day 8: The substance is applied to the treated area (occlusive) at a slightly irritant concentration for 48 hours.
The control group is treated with the vehicle and FCA following the same conditions as for the treated group.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Concentrations: 0.5 ml of the test substance at the highest non irritant concentration (occlusive)
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- (α-hexylcinnamaldehyde (HCA), CAS No. 101-86-0)
- Positive control results:
- The percentage of animals showing a positive response was 31% (6/19).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water) - No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water) - No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol) - No. with + reactions:
- 12
- Total no. in group:
- 19
- Remarks on result:
- other: Test group Nº3
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº4
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
- Executive summary:
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance.
The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
Reference
The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Key study: Equivalent to EU method B.6. No data on GLP.
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the substance is classified as Skin sensitiser Category 1A.
Guinea pig maximisation test:
≥ 30 % responding at ≤ 0,1 % intradermal induction dose or
≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose
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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