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EC number: 243-325-5 | CAS number: 19800-42-1
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- guinea pig maximization test (GPMT)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 10, 1999 to September 10, 1999
- 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
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A GPMT study was submitted as this was already available before the requirement for LLNA testing was published.
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- From Harlan Winkelmann
Bodyweight (mean): 362g
Groups of 5 animals
Temperature: 20 +/- 3°C and Relative humidity: 50 +/- 20%
Lighting time: 12 hours daily
Food and water: ssniff Ms-H (V2233) and tap water (ad libitum) - Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 5% (with and without Freund's Complete Adjuvant)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25% in 0.5 mL
- Day(s)/duration:
- 48h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25% in 0.5 mL
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- RANGE FINDING TEST
Determination of the primary non-irritant concentration 3
Determination of the tolerance of the intradermal injections 2
MAIN STUDY
Control group 5
Test substance group 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration
Determination of the tolerance of the intradermal injections
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2*0.1 mL 5% intradermal + 0.5 mL 25% epidermal
- Exposure period: dermal: 48 h
- Test groups: 1
- Control group: 1
- Site: intradermal: dorsal neck
- Frequency of applications: 1 intradermal, 1 dermal
- Duration: 21 days
- Concentrations: intradermal: 5%; dermal: 25%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22 of the study
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flanks
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h after removal of patches (= 48 and 72 h after start of challenge) - Challenge controls:
- left flank
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde (50% in PEG 400).
- Positive control results:
- 80% of the treated animals exhibited a positive skin reaction during the observation period.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of a Guinea pig maximisation study, the test substance was not sensitizing.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance (in the form of a brown powder of 38.8% purity) according to OECD Guideline 406 and EU Method B.6 (guinea pig maximization test (GPMT)). Female Pirbright-White guinea pigs (5 controls and 10/test group) were first exposed to the substance indradermally (injections of 50% Freund’s Adjuvant, 5% test substance in sesame oil, or 5% test substance in 50% Freund’s Adjuvant) and dermally (25.0% test substance in sesame oil) for 48 h. The dermal challenge consisted in the application of an occlusive bandage for 24 h with 25.0% test substance in sesame oil. Examinations were conducted 24 and 48 h after removal of the patches. The positive control used was alpha-hexyl cinnamic aldehyde and the vehicle (sesame oil) or the Freund’s Adjuvant served as negative control. The body weight gains of the animals were not impaired and the treated animals showed no signs of intoxication throughout the study. The positive control induced irritation in 80% of the animals and no skin reactions were observed in the negative control groups. None of the ten animals of the treatment group showed a positive skin response after the challende procedure. Under the study conditions, the test substance was considered to be not sensitizing to guinea pig (Seeberger, 1999).
Reference
Criterion for evaluation: the number of sensitized test animals (treshold of 30%).
Preliminary test results:
- Determination of the primary non-irritant concentration: no signs of irritation. The challenge was thus realized with the test substance at a concentration of 25% in sesame oil.
- Determination of the tolerance of the intradermal injections: the 5% preparation caused well defined erythema and edema, the 1.0% solution induced a slight irrition, and no effects were observed for the 0.2% test substance prepration. Based on those results, the 5% preparation was selected.
Main test results:
- The intradermal injections with Freund's Adjuvant (with or without test substance) caused severe erythema and edema as well as indurations, encrustations, and necrosis.When the test substance was administered with sesame oil, slight up to well defined erythema and oedema were observed. The vehicle alone did not cause any sign of irritation.
- After removal of the patches, severe erythema and edema, indurated and encrusted skin as well as necrosis were observed at the sites peviously treated with Freund's Adjuvant. The daministration sites treated with the test substance or the vehicle alone, showed no signs of irritation.
- For the dermal challenge treatment, no skin reactions were observed in the control and treatment groups, 24 and 48h after removal of the occlusive bandage.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to determine the skin sensitisation potential of the test substance (in the form of a brown powder of 38.8% purity) according to OECD Guideline 406 and EU Method B.6 (guinea pig maximization test (GPMT)). Female Pirbright-White guinea pigs (5 controls and 10/test group) were first exposed to the substance indradermally (injections of 50% Freund’s Adjuvant, 5% test substance in sesame oil, or 5% test substance in 50% Freund’s Adjuvant) and dermally (25.0% test substance in sesame oil) for 48 h. The dermal challenge consisted in the application of an occlusive bandage for 24 h with 25.0% test substance in sesame oil. Examinations were conducted 24 and 48 h after removal of the patches. The positive control used was alpha-hexyl cinnamic aldehyde and the vehicle (sesame oil) or the Freund’s Adjuvant served as negative control. The body weight gains of the animals were not impaired and the treated animals showed no signs of intoxication throughout the study. The positive control induced irritation in 80% of the animals and no skin reactions were observed in the negative control groups. None of the ten animals of the treatment group showed a positive skin response after the challende procedure. Under the study conditions, the test substance was considered to be not sensitizing to guinea pig (Seeberger, 1999).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of an in vivo guinea pig maximisation test, no classification for skin sensitization is required for the test substance according to CLP (EC 1272/2008) criteria.
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