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EC number: 303-757-8 | CAS number: 94213-53-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Study period:
- 08 March 2017 to 28 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc, Postbus 6174, 5960 AD Horst / The Netherlands
- Strain: CBA/CaOlaHsd
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 17.1- 19.9 g
- Housing: per dosing group in Makrolon Type III with wire mesh top
- Diet: 2018C Teklad Global 18% protein rodent diet ad libitum
- Drinkng water: tap water ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45-65%
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (3/7 v/v)
- Concentration:
- 5, 10, and 25 %
- No. of animals per dose:
- 4 females/concentration
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: max solubility 25%
- Irritation: none observed (1 female/concentration at 10 and 25%)
- Systemic toxicity: non observed
- Ear thickness measurements: no treatment related effects
- Erythema scores: max score : 1 on one occasion in the female treated at 25% (Draize)
MAIN STUDY: at 5, 10 and 25%
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance or vehicle (25 µL/ear/day) was spread over the entire dorsal surface (ca 8 mm) of each ear once daily for three consecutive days. On day 6 250 µL of phosphate-buffered saline containing 20.3 µCi of 3H-methyl thymidine was injected via the tail vein. Five hours thereafter mice were euthanized and lymphnodes were harvested and pooled (per dose group). Single cell suspensions of pooled lymphnodes were prepared and, after incubation in 5 % trichloroacetic acid for 18 hours at 4 °C, the 3HTdR incorporation was then measured in a β-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- NA
Results and discussion
- Positive control results:
- --> periodically investigated SI (25% 11.8; EC3 8.2%)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2.99
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 3.29
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 3.48
- Test group / Remarks:
- 25%
- Remarks on result:
- other:
- Remarks:
- one female died and was not included in the evaluation
- Key result
- Parameter:
- EC3
- Value:
- 5.2
- Cellular proliferation data / Observations:
- MORTALITY: one femaletrated with 25% died on day 3 of the study
CLINICAL OBSERVATIONS: none observed
BODY WEIGHTS: within normal ranges
Any other information on results incl. tables
Test item concentration % |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
17 |
--- |
--- |
--- |
--- |
--- |
BG II |
19 |
--- |
--- |
--- |
--- |
0 |
1 |
3059 |
3041 |
8 |
380.1 |
1.00 |
5 |
2 |
9100 |
9082 |
8 |
1135.2 |
2.99 |
10 |
3 |
10015 |
9997 |
8 |
1249.6 |
3.29 |
25 |
4 |
7961 |
7943 |
6 |
1323.8 |
3.48 |
1 = Control Group
2-4 = Test Group
a)= The mean value was taken from the figures BG I and BG II (BG = back ground)
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
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1B (indication of skin sensitising potential) based on CLP criteria
- Conclusions:
- The substance is considered to be sensitizing to the skin
- Executive summary:
In an LLNA test 4 female mouse/concentration were dermally (back of the ears) exposed to the substance at 0, 5, 10 and 25% during 3 consecutive days. After injection with 3H-thymidine, 3HTdR incorporation was measured in a β-scintillation counter in cell suspensions of pooled lymphnodes (per concentration). The EC3 calculated from the stimulation indices was 5.2%. The substance is considered sensitizing to the skin.
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