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EC number: 206-490-4 | CAS number: 349-76-8
- 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
Skin sensitisation:
A dermal sensitization test was conducted according OECD TG 406. Two groups of guinea pigs (10 vehicle control, 20 test) were included. On day 0, the test group animals were given a set of intradermal
injections (including 1.0% test item in peanut oil). The epidermal inductionapplication was made on day 8; the vehicle control animals were treated with the vehicle alone, and the test animals with 100% (undiluted) test item. The epidermal challenge application on day 21 consisted of a paired application of the vehicle alone and 5.0% test item in peanut oil in both groups. Skin reactions on both the vehicle and test flanks were scored 24 and 48 hours after completion of the challenge application, according to the Draize scale.
There were no positive skin responses among either the vehicle control or test group animals on either the vehicle flank or the test flank; the sensitization rate for the test item was therefore 0%. There was no mortality, and there were no remarkable clinical observations in any of the two groups. Body weights were not affected by treatment.
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:
- June - July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- 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.1998 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.
- Species:
- guinea pig
- Strain:
- other: Himalayan Spotted (GOHI)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 1-3 months
- Weight at study initiation: approx. 346-414 g
- Housing: individual (Macrolon Typ 3 cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- a set of intradermal injections was made on day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hours (on day 8)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 5%
- Day(s)/duration:
- 24 hours (on day 21)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- The Maximization test was conducted with 10 animals in the vehicle control group and 20 animals in the test group.
- Details on study design:
- Pre-tests, Intradermal Induction
Injections of 0.5, 1.0, 3.0 and 5.0% test item in peanut oil produced irritation at the injection site for all concentrations. The 1.0% concentration was selected for the induction injection for the definitive test, in that it was suitable for injection, systemically well tolerated, and produced mild to moderate skin irritation.
Pre-tests. Epidermal Application
Epidermal application of 1, 5, 10, 20, 30, 50, 70% and 100% (undiluted) concentrations produced skin irritation in both sexes at 10% and higher. The undiluted (100%) test article was selected for epidermal induction as the highest concentration to produce mild to moderate irritation. The 5.0% concentration was the highest concentration to produce no irritation (highest non-irritant dose), and was therefore
selected for the epidermal challenge application. - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- 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:
- 5%
- 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:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: not applicable
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A dermal sensitization test was conducted according OECD TG 406. Two groups of guinea pigs (10 vehicle control, 20 test) were included. On day 0, the test group animals were given a set of intradermal
injections (including 1.0% test item in peanut oil). The epidermal inductionapplication was made on day 8; the vehicle control animals were treated with the vehicle alone, and the test animals with 100% (undiluted) test item. The epidermal challenge application on day 21 consisted of a paired application of the vehicle alone and 5.0% test item in peanut oil in both groups. Skin reactions on both the vehicle and test flanks were
scored 24 and 48 hours after completion of the challenge application, according to the Draize scale.
There were no positive skin responses among either the vehicle control or test group animals on either the vehicle flank or the test flank; the sensitization rate for the test item was therefore 0%. There was no mortality, and there were no remarkable clinical observations in any of the two groups. Body weights were not affected by treatment.
Reference
There was no mortality, and there were no remarkable clinical observations in any of the two groups. Body weights were not affected by treatment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study result for skin sensitisation no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
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