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EC number: 245-728-1 | CAS number: 23552-74-1
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: current guideline; GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174; NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Housing: single; Makrolon Type I, with wire mesh top
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30 - 86
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- other: methyl ethyl ketone
- Concentration:
- 6,25 -12,5 -25 % (w/v)
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- positive (SI = 2,29 to 8,44)
- Parameter:
- SI
- Remarks on result:
- other: 0,8
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: < 465 per lymph node
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not induce sensitisation raction in mice in an LLNA assay.
- Executive summary:
In the study the test item dissolved in methyl ethyl ketone was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 6.25, 12.5, and 25 %.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After the second application reddening of the ears could not be determined since the ear skin of the animals was dyed blue by the test item.
In this study Stimulation Indices (S.I.) of 0.8, 0.7, 0.8 were determined with the test item at concentrations of 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone, respectively.
The test item was not a skin sensitiser in this assay.
Reference
Vehicle: methyl-ethyl-ketone
Test item concentration % (w/v)
|
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa)
|
number of lymph nodes
|
DPM per lymph nodeb) |
S.I.
|
|||
--- |
BG I |
0,0 |
--- |
--- |
--- |
--- |
--- |
BG II |
9,0 |
--- |
--- |
--- |
--- |
--- |
CG 1 |
4661,5 |
4657,0 |
8 |
582,1 |
|
6,25 |
TG 2 |
3721,3 |
3716,8 |
8 |
464,6 |
0,8 |
12,5 |
TG 3 |
3290,7 |
3286,2 |
8 |
410,8 |
0,7 |
25 |
TG 4 |
3535,1 |
3530,6 |
8 |
441,3 |
0,8 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
S.I. = Stimulation Index
a)= The mean value was taken from the figures BG I and BG II
b)= Since the lymph nodes of the animals of a dose group were pooled, DPM/node
was determined by dividing the measured value by the number of lymph nodes
pooled
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No sensitising potential was detected in mice using a local lymph node assay employing three concentrations. The stimulation indices were all below 0.8.
Migrated from Short description of key information:
No sensitising potential was detected in mice using a local lymph node assay.
Justification for selection of skin sensitisation endpoint:
Only study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No dermal sensitising potential was detected in mice using a local lymph node assay. For the dertermination of respiratory sensitisation no method is available.
Justification for classification or non-classification
The LLNA showed a clear negative result (not sensitising) therefore a classification is not warranted.
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