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EC number: 610-388-9 | CAS number: 478945-46-9
- 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
- Study period:
- From 23 January 2004 to 26 May 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No certificate of analysis was provided, two animals were found dead after treatment, no conclusion can be made for this mortality. There were still two animals for examinatiuon but it was insufficient according OECD method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Two animals were found dead approximately 1 hour after treatment. Analysis was performed on only 2 animals which survived.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,5-dimethyl 3-methyl-9-oxo-2,4-bis(pyridin-2-yl)-7-[(pyridin-2-yl)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate dichloroiron hydrate
- EC Number:
- 610-388-9
- Cas Number:
- 478945-46-9
- Molecular formula:
- C28H31N5O6FeCl2
- IUPAC Name:
- 1,5-dimethyl 3-methyl-9-oxo-2,4-bis(pyridin-2-yl)-7-[(pyridin-2-yl)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate dichloroiron hydrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SEAC sample number S2539801, supplied by the sponsor
- Expiration date of the lot/batch: not specified
- Purity test date: not specified. The supporting data for purity of the test item was not made available at the time of issuing this report and hence this information has been excluded from the statement of compliance. However, the sponsor has adressed this is in a GLP compliant study, SEAC Study Reference Number AC030449
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20±3 deg celsius), protected from the light
- Stability under test conditions: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was weighed and applied undiluted as delivered by the sponsor.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 12-13 weeks (male) and 11-13 weeks (female)
- Weight at study initiation: 2032g to 2143g
- Housing: Individually in stainless steel equipped with feed hoppers and drinking water bowls. Wood blocks and haystick were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 6-7 Days under laboratory conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 deg Celsius
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h/12h. Music was played during the daytime light period
IN-LIFE DATES: From: 27 January 2004 To: 2 March 20047
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL was used (equivalent to 0.03g of test item)
- Concentration (if solution): not applicable
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- Four rabbits were used (two were found dead)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No removal of test substrance
SCORING SYSTEM: EEC Commission Directive 92/69/EEC, July 31, 1992 Grading of Ocular Lesions
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 hour
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- In the two surviving rabbits (one male and one female), only the female showed ocular changes such as a slight opacity in the whole corneal area, a moderate redness of the conjunctivae and sclera was still observed at the 24 hours reading. These effects were reversible and were no longer evident 48 hours after treatment. In the second animal (male) no abnormal findings were noted, at any assessment times.
- Other effects:
- Two females treated in this study died after test item instillation. The first animal was found dead one hour after treatment and the second 40 minutes after treatment. They were necropsied. No clinical signs were observed immediately after the treatment. The animals were not continuously observed before the 1-hour reading as no death and no clinical signs were expected. No clinical signs were observed in the two surviving animals.
No staining of the treated eyes produced by the test item was observed
No corrosion of the cornea was obsrved at any reading times
No macroscopic finding were noted in the two surviving animal at the end of the study. Several pale foci were seen in the heart of the first female which was found dead. The lungs of additional female which was found dead (second animal) were dark red discolored.
Any other information on results incl. tables
Table 1summary of result
Bodyweight in grams |
|
|
|
|
|
|
|
|
Animal |
sex |
evaluation interval |
corneal opacity |
area ofopacity |
iris |
redness |
chemosis |
sclera |
24 |
M |
1hour |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
F |
|
1 |
4 |
0 |
2 |
2 |
2 |
24 |
M |
24hours |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
F |
|
0 |
0 |
0 |
1 |
0 |
1 |
24 |
M |
48hours |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
F |
|
0 |
0 |
0 |
0 |
0 |
0 |
24 |
M |
72hours |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
F |
|
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of the study, the registered item was not irritating for rabbit eyes. According to the CLP criteria, the substance Stainless E-700-2003 was not classified for eye irritation.
- Executive summary:
The GLP compliant study was perfomed to assess the potential irritancy of the Stainless E-700 -2003 in rabbit according to OECD 405 method.
4 New Zealand rabbits were used. 0.1 mL of the registered substance (equivalent to 0.03g of substance) was applied on left eye of each rabbits. Clinical signs, irritation and macroscopic examinations were performed.
In the two surviving rabbits (one male and one female), only the female showed ocular changes such as a slight opacity in the whole corneal area, a moderate redness of the conjunctivae and sclera was still observed at the 24 hours reading. These effects were reversible and were no longer evident 48 hours after treatment. In the second animal (male) no abnormal findings were noted, at any assessment times.
Two females treated in this study died after test item instillation. The first animal was found dead one hour after treatment and the second 40 minutes after treatment. They were necropsied. No clinical signs were observed immediately after the treatment. The animals were not continuously observed before the 1-hour reading as no death and no clinical signs were expected. No clinical signs were observed in the two surviving animals.
Under the experimental conditions of the study, the registered item was not irritating for rabbit eyes. According to the CLP criteria, the substance Stainless E-700-2003 was not classified for eye irritation.
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