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EC number: 208-048-6 | CAS number: 506-64-9
- 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:
- 08 October 2013 to 29 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as an unpublished report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This was an exception with regard to GLP and was reflected in the GLP compliance statement.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: Individually housed in suspended soild floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Food available ad libitum (2014C Tekland Global Rodent diet, Harlan Laboratories Ltd., Oxon, UK)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h of light (6.00 to 18.00)/ 12 h of dark
IN-LIFE DATES: From: 08 October 2013 To: 29 November 2013 - Vehicle:
- other: cotton seed oil
- Concentration:
- Preliminary test: 2.5 % w/w
Main test: 0.5, 1 and 2.5 % w/w - No. of animals per dose:
- Preliminary test: 1 female
Main test: 4 females per dose - Details on study design:
- RANGE FINDING TESTS:
- Design: One mouse was treated by daily application of the test item at a concentration of 2.5% w/w in cottonseed oil, to the dorsal surface of each ear (25 µL per ear) for 3 consecutive days. The mouse was observed twice daily on days 1-3 and once daily on days 4-6. Local skin irritation was scored daily. Any clinical signs of toxicity were recorded. The bodyweight was recorded on day 1 and on day 6. the thickness of each ear was measured using a Mitutoyo 547-300S gauge, pre-dose on day 1, post-dose on day 3 and 6. Mean ear thickness changes were calculated between time periods day 1 and 3 and days 3 and 6.
- Irritation: A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitisation.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT:
Groups of 4 mice were treated with the test item at concentrations of 0.5, 1.0 and 2.5 % w/w in cottonseed oil. The mice were treated by daily application of the test item at a concentration of 2.5% w/w in cottonseed oil, to the dorsal surface of each ear (25 µL per ear) for 3 consecutive days. Five days after the first topical application all mice were injected via the tail vein with 250 µL of PBS containing 3H-methyl thymidine (80 µCi/mL, specific activity 2.0 Ci/mmol) giving a total of 20 µCi to each mouse.
- Name of test method: 3H-methyl thymidine incorporation
- Observations: clinical observations performed twice daily on days 1-3 and daily on days 4-6. Bodyweight of each mouse was recorded on day 1 (prior to dosing) and day 6 (prior to termination).
- Terminal procedures: 5 hours after administration of 3HTdR all mice were sacrificed and a single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish and the lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm for 10 min. The pellet was resuspended in 10 mL PBS and repelleted. To precipitate out the radioactive material, the pellet was resuspended in 3 mL of 5% Trichloroacetic acid (TCA). After approx. 18 h of incubation at 4 °C, the precipitates were recovered by centrifugation at 2100 rpm for 10 min., resuspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid. 3HTdR incorporation was measured by β-scintillation counting. The number of radioactive disintegrations per minute was measured using the Beckmann LS6500 scintillation system.
- Criteria used to consider a positive response: The test item is regarded as a sensitizer if at least one concentration of the test item results in a three-fold or greater increase in 3H-methyl thymidine incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was freshly prepared as a suspension in cottonseed oil within 2 hours of being applied to the test system. It was assumed that the formulation was stable for this duration. The test item was applied once daily to the dorsal surface of each ear for three consecutive days. The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- ɑ-Hexylcinnamaldehyde tech., 85% was considered to be a sensitiser under the condition of the test. The simultation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group was 8.84.
- Parameter:
- SI
- Remarks on result:
- other: The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control were 1.00, 0.88 and 1.09 for 0.5, 1.0 and 2.5 % w/w, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The radioactive disintegration per minute were 14,961.65, 14,923.84, 13,100.12 and 16,313.78 dpm for vehicle control, 0.5, 1.0 and 2.5 % w/w, respectively.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item, silver cyanide, was considered to be a non-sensitizer under the conditions of the test.
- Executive summary:
Introduction
A study was performed to assess the skin sensitization potential of silver cyanide in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The study was conducted according to the OECD Guideline 429 ('Skin sensitization: Local Lymph Node Assay') and EC method B42. The test was carried out according to GLP.
Materials and Methods
Following a preliminary test, the main test was conducted with groups of 4 mice treated with the test item at concentrations of 0.5, 1.0 and 2.5 % w/w in cottonseed oil. The mice were treated by daily application of 25 µL of the test item to the dorsal surface of each ear for three consecutive days. A further group of four mice received the vehicle alone. Five days after the first topical application all mice were injected with PBS containing 3H -methyl thymidine.
Results
The radioactive disintegration per minute were 14,961.65, 14,923.84, 13,100.12 and 16,313.78 dpm for vehicle control, 0.5, 1.0 and 2.5 % w/w, respectively. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control were 1.00, 0.88 and 1.09 for 0.5, 1.0 and 2.5 % w/w, respectively. The test item, silver cyanide, was considered to be a non-sensitizer under the conditions of the test.
Reference
Table 1. Local skin irritation - Preliminary Screening Test
Concentration (% w/w) in cottonseed oil |
Animal number |
Local skin irritation |
|||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
||
2.5 |
S-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2. Measurement of Ear Thickness and Mean Ear Thickness Changes - Preliminary Screening Test
Concentration (% w/w) in cottonseed oil |
Animal number |
Ear thickness measurement (mm) |
|||||
Day 1 |
Day 3 |
Day 6 |
|||||
Pre-dose |
Post-dose |
||||||
left |
right |
left |
right |
left |
right |
||
2.5 |
S-1 |
0.22 |
0.20 |
0.22 |
0.21 |
0.24 |
0.23 |
Overall mean (mm) |
0.21 |
0.22 |
0.24 |
||||
Overall mean ear thickness change (%) |
na |
2.38 |
11.90 |
Table 3. Disintegration per Minute, Disintegration per Minute/Node and Stimulation Index
Concentration (% w/w) in cottonseed oil |
dpm |
Dpm/Node |
Stimulation Index |
Result |
Vehicle control |
14961.65 |
1870.21 |
N/A |
N/A |
0.5 |
14923.84 |
1865.48 |
1.00 |
Negative |
1 |
13100.12 |
1637.52 |
0.88 |
Negative |
2.5 |
16313.78 |
2039.22 |
1.09 |
Negative |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was performed to assess the skin sensitization potential of silver cyanide in the CBA/Ca strain mouse following topical application to the ear. Groups of 4 mice were treated with nominal concentrations of 0.5, 1.0 and 2.5 % silver cyanide w/w in cottonseed oil, applied on three consecutive days to the dorsal surface of each ear in a volume of 25µL. The Stimulation Indices were 1.00, 0.88 and 1.09 for 0.5, 1.0 and 2.5 % w/w, respectively. Silver cyanide is considered to be a non-sensitizer based on EU guidelines, under the conditions of the test.
Migrated from Short description of key information:
Mouse Local Lymph Node Assay (OECD429)
Justification for selection of skin sensitisation endpoint:
A single Guideline (OECD429) study conducted to GLP standard showing no evidence of skin sensitisation based on EU criteria.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification is required for skin sensitisation, as a negative result was observed in an in vivo mouse LLNA.
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