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EC number: 235-243-3 | CAS number: 12138-09-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tungsten
- EC Number:
- 231-143-9
- EC Name:
- Tungsten
- Cas Number:
- 7440-33-7
- Molecular formula:
- W
- IUPAC Name:
- tungsten
- Reference substance name:
- Sulfur
- EC Number:
- 231-722-6
- EC Name:
- Sulfur
- Cas Number:
- 7704-34-9
- Molecular formula:
- S
- IUPAC Name:
- sulfur
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Particle size distribution: D50= 3.1 um; D90=6.5 um
- Mass median aerodynamic diameter (MMAD):
- Density: 7.69 g/cm3
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: between 1.0 and 3.5 kg
- Housing: Individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: at least 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):93.6 (93.4 - 93.8) mg of the test substance (a volume of approximately 0.1 ml) - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation of the test substance
- Number of animals or in vitro replicates:
- 3 animals of one sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): approximately 50 ml tepid tap-water
- Time after start of exposure: 24 h
SCORING SYSTEM:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal lustre)..........................................O
Scattered or diffuse areas of opacity, details of iris clearly visible............................................ 1
Easily discernible translucent area, details of iris slightly obscured.......................................... 2
Nacreous area, no details of iris visible, size of pupil barely discernible.................................... 3
Opaque cornea, iris not discernible through the opacity............................................................ 4
Area of cornea involved:
No ulceration or opacity............................................................................................................O
One quarter or less but not zero................................................................................................. 1
Greater than one quarter, but less than half............................................................................... 2
Greater than half, but less than three quarters........................................................................... 3
Greater than three quarters, up to whole area.......................................................................... 4
IRIS
Normal.......................................................................................................................................... 0
Markedly deepened rugae, congestion, swelling, moderate circumcomeal hyperaemia, or injection, any of these or combination thereof, iris still reacting to light
(sluggish reaction is positive)...................................................................................................... 1
No reaction to light, hemorrhage, gross destruction (any or all of these)...................................2
CONJUNCT/VAL IRRITAT/ON
Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal.................................................................................................................. 0
Some blood vessels definitely hyperaemic (injected)................................................................. 1
Diffuse, crimson color, individual vessels not easily discernible................................................ 2
Diffuse beefy red........................................................................................................................ 3
Chemosis (refers to lids and/or nictitating membranes):
No swelling.................................................................................................................................. 0
Any swelling above normal (includes nictitating membranes).................................................... 1
Obvious swelling with partial eversion of lids............................................................................ 2
Swelling with lids about half closed........................................................................................... 3
Swelling with lids more than half closed .....................................................................................4
Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals).........0
Any amount different from normal and/or lacrimation................................................................. 1
Discharge with moistening of the lids and hairs just adjacent to lids.......................................... 2
Discharge with moistening of the lids and hairs (considerable area around the eye)................3
Where standard lighting is considered inadequate for observing minor effects, eye examinations will be performed using an ophthalmic examination lamp.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 will be used for additional control purposes.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animals: #98, #100, #102
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animals: #98, #100, #102
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animals: #98, #100, #102
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- Animals: #98, #100, #102
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
TABLE 1: INDIVIDUAL EYE IRRITATION SCORES
|
Cornea |
|
Iris |
|
Conjunctivae |
|
||
Time after dosing |
Opacity |
Area |
Fluor area(%) |
|
Redness |
Chemosis |
Discharge |
Comments |
r3No 98# |
|
|
|
|
|
|
|
|
1 hour |
0 |
0 |
|
1 |
1 |
2 |
2 |
abce |
24 hours |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
be |
48 hours |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
r3No 100# |
|
|
|
|
|
|
|
|
1 hour |
0 |
0 |
|
1 |
1 |
2 |
2 |
abce |
24 hours |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
be |
48 hours |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
r3No 102# |
|
|
|
|
|
|
|
|
1 hour |
0 |
0 |
|
1 |
2 |
2 |
1 |
abce |
24 hours |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
TABLE 2: MEAN VALUE EYE IRRITATION SCORES
Animal: Corneal:
|
opacity |
|
Redness |
Chemosis |
98 |
0 |
0 |
0.3 |
0.3 |
100 |
0 |
0 |
0.3 |
0.0 |
102 |
0 |
0 |
0.3 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TUNGSTEN DISULFIDE does not have to be classified and has no obligatory labelling requirement for eye irritation
- Executive summary:
The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.5, "Acute Toxicity - Eye irritation" and OECD No.405, "Acute Eye Irritation/Corrosion".
Single samples of approximately 94 mg of TUNGSTEN DISULFIDE (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.
Instillation of the test substance resulted in effects on the iris and conjunctivae.
lridial irritation (grade 1) was observed in all animals and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 48 hours in all animals. Grey staining of (peri) ocular tissues by the test substance was observed on day 1. Due to this staining, the eyelids, nictitating membrane and sclera could be scored partly (upper part).
Remnants of the test substance were present in the eyes of two animals on days 1 and 2 and in one animal on day 1. Remnants of the test substance were present on the outside of the eyelids of two animals on days 1 and 2 and of one animal on day 1. Grey staining of the fur on the head and paws, caused by the test substance, was noted on day 1.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TUNGSTEN DISULFIDE does not have to be classified and has no obligatory labelling requirement for eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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