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EC number: 269-284-3 | CAS number: 68214-04-0
- 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
The substance was tested in a local lymphnode assay in 5 mice per dose (at 100, 50 and 25%). Following 3 days of treatment, on day 6 mice received 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine and were terminated 5 hours later. The lymphnodes were excised, pooled and prepared cells suspensions were assessed for 125I incorporation. Simulation indices were calculated to be 2.72, 3.56 and 4.44 at 25, 50 and 100%. The EC3 was calculated to be 33.25%. Based on this finding the substance is considered a skin sensitizer (category 1B)
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:
- 21 September 2016 to 11 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: AnLab Prague, Czech Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 17.5-22.6 g
- Housing: individually in polypropylene cages suspended on stainless steel racks with Lignocel S3/4 bedding
- Diet: ssniff (ssniff Spezialdiäten GmbH, Germany) ad libitum
- Water: tap (drinking) water ad libitum
- Acclimation period: 6 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 22 ± 2°C
- Humidity (%): 50-60 %
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- main study: 5 females/concentration
- Details on study design:
- PRE-SCREEN TESTS: on 2 females at 100%
- Compound solubility: NA (tested as such)
- Irritation: none
- Systemic toxicity: none
- Ear thickness measurements: 0.17-0.18 over 6 day period
- Erythema scores: no erythema observed
MAIN STUDY:
Day 1-3: application of 25µL of the appropriate dilution to the dorsum of each ear
Days 4 and 5: No treatment.
Day 6: 250µL of phosphate-buffered saline (PBS) containing 2 µCi (7.4 x 104 Bq) of 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine was injected into all test and control mice via the tail vein.
Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach) and weighted.
- Body weight: on day 1 and 6
- Clinical signs: daily - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- EC3 value: by linear interpolation of points on dose-response curve, immediately above and below SI value of 3
- Positive control results:
- positive controls were within historical control ranges
- Key result
- Parameter:
- SI
- Value:
- 2.72
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 3.56
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 4.44
- Test group / Remarks:
- 100%
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The substance is a skin sensitizer
- Executive summary:
The substance was tested in a local lymphnode assay in 5 mice per dose (at 100, 50 and 25%). Following 3 days of treatment, on day 6 mice received 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine and were terminated 5 hours later. The lymphnodes were excised, pooled and prepared cells suspensions were assessed for 125I incorporation. Simulation indices were calculated to be 2.72, 3.56 and 4.44 at 25, 50 and 100%. The EC3 was calculated to be 33.25%. Based on this finding the substance is considered a skin sensitizer (category 1B)
Reference
Lymph node weight, DPM, SI, EC3 values.
|
Lymph node |
Number of |
|
|
|
|
weight (g) |
lymph nodes |
DPM |
SI |
EC3 |
Control |
0.0394 |
10 |
589 |
- |
33.25
|
Positive Control |
0.0737 |
10 |
3961 |
6.21 |
|
Reactive Red 120 25% |
0.0695 |
10 |
1603 |
2.72 |
|
Reactive Red 120 50% |
0.0712 |
10 |
2099 |
3.56 |
|
Reactive Red 120 100% |
0.0777 |
10 |
2618 |
4.44 |
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 substance needs to be classified as a skin sensitizer: category 1B H317 according to Regulation (EC) No 1272/2008 (CLP)
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