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EC number: 929-889-1 | 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
Endpoint summary
Administrative data
Description of key information
A study was conducted to assess the skin sensitizing potential of the test item in a guinea-pig maximisation test according to OECD Guideline 406 and EU method B.6.
The intradermal induction was performed using a 2.5% test item concentration in polyethylene glycol 400, and the topical induction was performed with a 100% test item concentration. After the intradermal induction the animals in the control group and in the test item group showed strong effects up to encrustation at the injection sites of the first induction. The challenge with the 25% test item formulation led to skin effects (grade 1 - 3) in 17 of 20 animals (85%) in the test item group and no skin effects were seen in the control group animals.
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
- Study period:
- April 02 - April 26, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test was performed in accordance to the OECD guideline 406 and can be considered as a validated and reliable testing method for skin sensitization including a high statistical sample size and the challenge phase. In the beginning of 2001 the GPMT was the generally accepted in vivo model for the assessment of the skin sensitisation potential of substances in science and regulatory context. The adoption of the LLNA as a new Test Guideline is dated 24th April 2002.
- Specific details on test material used for the study:
- - Solubility and stability of the test substance in the solvent/vehicle: The stability of the test item in the vehicle was analytically verified for up to 2 hours.
- Treatment of test material prior to testing: The test item was formulated in polyethylene glycol 400. The formulations were visually described as solutions. - Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals:
-Reason for this choice: Species generally accepted by regulatory authorities for this type of study. The strain used has been shown to produce a satisfactory sensitization response using known sensitizers.
-Breeder: Harlan Winkelmann GmbH Laboratory, 33176 Borchen, Germany
-Number: 7 for the preliminary test, 30 animals for the main test.
-Age/weight: 5 - 6 weeks/284 -383 grams
-Acclimation: At least 5 d before the beginning of the study.
-Identification of the animals: Ear-tattoo.
Environmental conditions:
-Temperature: 22 ± 3°C
-Relative humidity: 40 to 60%
-Light/dark cycle: 12 h/ 12 h
-Ventilation: Approx >= 10 times per hour - Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal: 2.5% (= 10 mg test item/animal)
Topical: 100% (= 500 mg test item/animal) - Day(s)/duration:
- once - the injection sites were visually assessed 2 and 7 days after the injections One week after the intradermal induction the topical (48-hour exposure period) was performed
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- range finding group: 7 animals
test item group: 20 animals
control group: 10 animals - Challenge controls:
- A patch loaded only with the vehicle was placed also on the right flank (cranial) as control.
- Positive control substance(s):
- yes
- Remarks:
- Vohr, H.-W.: Validation of the Magnusson - Kligman Maximization Test Method used by the Fachbereich Toxikologie, Bayer AG, performed in Guinea Pigs of the Strain Hsd:Poc:DH with Alpha-Hexylzimtaldehyd (BAYER-AG, PH 31458, November 2001).
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Executive summary:
A study was conducted to assess the sensitizing potential of the test item in a guinea-pig maximisation test according to OECD Guideline 406 and EU method B.6.
The intradermal induction was performed using a 2.5% test item concentration in polyethylene glycol 400, and the topical induction was performed with a 100% test item concentration. After the intradermal induction the animals in the control group and in the test item group showed strong effects up to encrustation at the injection sites of the first induction. The challenge with the 25% test item formulation led to skin effects (grade 1 - 3) in 17 of 20 animals (85%) in the test item group and no skin effects were seen in the control group animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test item induced delayed contact hypersensitivity in guinea pig maximisation study and is therefore considered to be a skin sensitizer. Hence, it qualifies for classification as Skin Sens 1B (H317-May cause an allergic skin reaction) according to Regulation (EC) 1272/2008.
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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