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EC number: 807-717-5 | CAS number: 295800-70-3
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out according to OECD Guideline No. 402 and EEC Directive 84/449/EEC, Part B.3 and in accordance with the Principles of Good Laboratory Practices (GLP).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- 1,4-bis[(2-ethylhexyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione
- EC Number:
- 807-717-5
- Cas Number:
- 295800-70-3
- Molecular formula:
- C30H42N2O4
- IUPAC Name:
- 1,4-bis[(2-ethylhexyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione
- Test material form:
- other: blue solid
- Details on test material:
- - Name of test material (as cited in study report): Spectrace MD-810 Marker (Solvent Free)
- Physical state: Blue solid
- Lot/batch No.: Lot #RWS-2-43, TD#04-049
- Expiration date of the lot/batch: September 23, 2007
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: Stored at room tempertaure.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Inc., Boyertown, PA
- Age at study initiation: Young adult (9-10 weeks).
- Fasting period before study:
- Weight at study initiation: males 297-328 grams and females 190-203 grams.
- Housing:The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHE W (hlH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 40% w/w mixture. Two thousand mag of body weight of the test substance was then applied to a 2-inch x 3-inch, 4-ply gauze pad and placed on a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface). The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance. The rats were then returned to their designated cages. The day of application was considered Day 0 of the study.
REMOVAL OF TEST SUBSTANCE
After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed of any residual test substance.
TEST MATERIAL
The test substance was a blue solid and was stored at room temperature. In order to insure adequate contact with the skin, the sample was applied as a dry paste (40% w/w mixture in distilled water). Preliminary sample preparation conducted by PSL indicated mixtures in excess of 40% (i.e., 45%-90%) were too dry to assure adequate skin contact.
VEHICLE
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 40% w/w mixture. - Duration of exposure:
- 24 Hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter. Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000
- Based on:
- test mat.
- Remarks on result:
- other: n/a
- Mortality:
- No mortality occurred during the study period
- Clinical signs:
- other: There were no signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnormal behavior.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- Not applicable
Any other information on results incl. tables
Acute dermal Dose
Animal No. |
Sex |
Dose Level (mg/kg) |
Body Weight (g) |
Dose |
||
Initial |
Day 7 |
Day 14 |
g |
|||
8508 |
M |
2,000 |
328 |
351 |
436 |
1.6 |
8509 |
M |
306 |
332 |
397 |
1.5 |
|
8510 |
M |
297 |
325 |
401 |
1.5 |
|
8511 |
M |
313 |
342 |
416 |
1.6 |
|
8512 |
M |
300 |
330 |
390 |
1.5 |
|
8513 |
F |
197 |
236 |
253 |
0.99 |
|
8514 |
F |
200 |
235 |
255 |
1.0 |
|
8515 |
F |
203 |
241 |
261 |
1.0 |
|
8516 |
F |
190 |
217 |
247 |
0.95 |
|
8517 |
F |
201 |
226 |
250 |
1.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the dermal LD50 value of Spectrace® MD-810 Marker (Solvent Free) in rats of either sex was established as exceeding 2000 mg/kg body weight.
- Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for Spectrace® MD-810
Marker (Solvent Free) to produce toxicity from a single topical application. Under the conditions of this
study, the single dose acute dermal of the test substance is greater than 2,000 mg/kg of body weight in
male and female rats. Classification according to HMIS, EPA, EEC, and WHMIS are presented in Table
4.
Two thousand milligrams per kilogram of body weight of the test substance was moistened with distilled
water and applied to the skin of ten healthy rats for 24 hours. The animals were observed for mortality,
signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were
recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all
animals at terminal sacrifice.
All animals survived, gained body weight, and appeared active and healthy. There were no signs of gross
toxicity, dermal irritation, adverse pharmacologic effects or abnormal behavior. No gross abnormalities
were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
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