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Registration Dossier
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EC number: 915-093-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1998-03-02 to 1999-09-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, scientifically sound study that was conducted according to GLP and OECD Guideline 405 with no deviations.
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH: The hypothesis is that properties are likely to be similar or follow a similar pattern because of the presence of a common metal ion, in this case tungstate.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES):
Source: Tungsten Carbide
Target: Fused tungsten carbide
3. CATEGORY APPROACH JUSTIFICATION: See Annex 3 in CSR
4. DATA MATRIX: See Annex 3 in CSR
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report for SIAM 21 for Tungsten Carbide (12070-12-1), Washington DC,18-20 October, 2005
- Author:
- OECD-SIDS
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tungsten carbide
- EC Number:
- 235-123-0
- EC Name:
- Tungsten carbide
- Cas Number:
- 12070-12-1
- Molecular formula:
- CW
- IUPAC Name:
- tungsten carbide
- Details on test material:
- - Name of test material: Tungsten Carbide Powder - Pure- Source: Supplied by the Sponsor- Physical state: Grey powder- Analytical purity: >99.98%- Purity test date: January 27, 1998- Stability under test conditions: Stable- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: 13 to 15 weeks
- Weight at study initiation: 3.1 to 3.5 kg
- Housing:Individually in metal cages with perforated floors.
- Diet (ad libitum): ad libitum STANRAB (P) SQC Rabbit Diet
- Water (e.g. ad libitum): ad libitium
- Acclimation period: Yes, but no time span given.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 34 - 65%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12 (0700 - 1900 hours)
IN-LIFE DATES: From: 1998-03-02 To: 1998-03-08
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Weight of 0.1 mL test material (100 mg); 579, 526, 590. Mean weight of 0.1 mL test substance: 565 mg. - Duration of treatment / exposure:
- A single instillation
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not rinsed
SCORING SYSTEM: Ocular irritation was scored according to Draize.
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- for all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- for all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- No iridial iritation or damage was observed throughout the study
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- for all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Remarks:
- Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Remarks:
- Redness
- Irritant / corrosive response data:
- - No corneal damage or iridial inflammation was observed.
- Other effects:
- - A diffuse crimson colouration of the conjuctivae with or without slight swelling (grade 1 or 2) was seen in two animals up to 24 hours; in the remaining rabbit chemosis grade 1 was observed only 1 hour after instillation; 48 hours after instillation all ocular reactions had resolved. Tungsten carbide
showed only a transient very slight to well-defined conjunctival irritation.
- Transient hyperaemia of blood vessels was observed in the remaining rabbit. These reactions had resolved by either one or two days after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of Tungsten Carbide Powder - Pure into the rabbit eye elicited transient very slight to well-defined conjunctival irritation only. Based on theresults of this study, tungsten carbide can be considered as non-irritant.
- Executive summary:
No eye irritation data of sufficient quality are available for fused tungsten carbide (target substance). However, eye irritation data are available for tungsten carbide (source substance), which will be used for read-across. Due to similar water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate. In addition, read-across is appropriate because the classification and labelling is similar for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission and/or as an Annex in the CSR.
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