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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 December 2003 to 05 April 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- 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: provided by the sponsor, SEAC sample number S2539801
- Expiration date of the lot/batch: 1 January 2005
- Purity test date: 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 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 light.
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 11-12 weeks (male and female)
- Weight at study initiation: male 1994g, female 1: 2063g, female 2 : 2029g
- Housing: Individually in stainless steel cages equipped with feed
hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance
diet ad libitum
- Water (e.g. ad libitum): Community tap water ad libitum
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study. From 06-JAN-2004 to 11-JAN-2004
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 17-23 deg celsius
- Humidity (%): 30-70% relative humidity
- Air changes (per hr): 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
IN-LIFE DATES: From: 6 January 2004 To:15 January 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- purified water
- Controls:
- yes
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): 0.5g moistened in 0.1 mL of purified water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour (for two animals), 24, 48 and 72 hours after patch
removal - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- % coverage: 4x4 cm : 16 cm2
- Type of wrap if used: The dressing was wrapped around the abdomen and anchored with tape. No more details
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test item.
SCORING SYSTEM:
- Method of calculation: Grading of Skin Reactions
ERYTHEMA AND ESCHAR FORMATION
No erythema ........................................................................................................................ 0
Very slight erythema............................................................................................................ 1
Well-defined erythema ........................................................................................................ 2
Moderate to severe erythema.............................................................................................. 3
Severe erythema (beet redness) or eschar
formation (injuries in depth preventing erythema) reading .................................................. 4
OEDEMA FORMATION
No oedema.......................................................................................................................... 0
Very slight oedema (barely perceptible) .............................................................................. 1
Slight oedema (edges of area well-defined by definite raising) ........................................... 2
Moderate oedema (edges raised approximately 1 mm)...................................................... 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) .... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score and the mean oedema score were 0.00 for all three animals.Very slight erythema was observed in two animals at the 1-hour reading. No abnormal findings were observed on the treated skin of any animal 24 hours after treatment.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Any other information on results incl. tables
Table1 :Body weights of the rabbits
Body weight in grams |
||||
Animal No. |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
21 |
male |
1994 |
2195 |
2219 |
22 |
female |
2063 |
2046 |
2156 |
23 |
female |
2029 |
2244 |
2315 |
TABLE 2: SKINIRRITATION SCORES - INDIVIDUAL VALUES
Animal Number |
Sex |
Evaluation Interval* |
Erythema |
Oedema |
21 22 23 |
M FF |
1 hour |
1 1 0 |
0 0 0 |
21 22 23 |
M FF |
24 hours |
0 0 0 |
0 0 0 |
21 22 23 |
M FF |
48 hours |
0 0 0 |
0 0 0 |
21 22 23 |
M FF |
72 hours |
0 0 0 |
0 0 0 |
* Examinations were performed at the specified times after removal of the dressing.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under experimental condition of the study, the test item did not induce significant or irreversible damage to the skin. Based upon the CLP criteria, STAINLESS E-700-2003 is considered to be “not irritating” to rabbit skin.
- Executive summary:
The primary skin irritation potential of STAINLESS E-700-2003 was investigated according to OECD test guideline no. 404 and OECD GLP principle.
The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
The mean erythema/eschar score and the mean oedema score were 0.00 for all three animals.
The application of STAINLESS E-700-2003 to the skin resulted in mild signs of irritation (very slight erythema), in two animals. This effect was reversible and was no longer evident 24 hours after treatment. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no other clinical signs of test item related effects were observed.
Thus, the test item did not induce significant or irreversible damage to the skin. Based upon the CLP criteria, STAINLESS E-700-2003 is considered to be “not irritating” to rabbit skin.
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