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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 conducted according to OECD TG 404 and U.S. EPA Health Effects TG, OPPTS 870.2500 and in accordance with the Principles of Good Laboratory Practice (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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
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-8 10 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 temperature.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received fiom Robinson Services, Inc. Clemmons, NC on November 10,2004.
- Age at study initiation: Young adult.
- 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 DHEW (NIH).
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Photoperiod (hrs dark / hrs light): 12-hour lightfdark cycle
IN-LIFE DATES: From: November 18, 2004 To: November 21, 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test substance was moistened with distilled water to achieve a dry paste by preparing a 45% w/w mixture. Five-tenths of a gram of the test substance (1.11 g of the test mixture) was applied to each animal. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. 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.
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE:
On the day before application, a group of animals was prepared by clipping (Oster model #A5-small) the dorsal area and the trunk. On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healthy animals without preexisting skin irritation were selected for test.
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 45% w/w mixture. Five-tenths of a gram of the test substance (1.1 1 g of the test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to one 6-cm2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
REMOVAL OF TEST SUBSTANCE:
After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.
SCORING SYSTEM:
Individual dose sites were scored according to the Draize scoring system (see Table 3) at approximately 1, 24, 48 and 72 hours after patch removal. The Primary Dermal Irritation Index (PDII) was obtained by adding the average erythema and edema scores for the 1, 24, 48 and 72-hour scoring intervals and dividing by the number of evaluation intervals (4).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 13096
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score for 24, 48 and 72 hr is 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 13097
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score for 24, 48 and 72 hr is 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 13098
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score for 24, 48 and 72 hr is 0
- Irritation parameter:
- edema score
- Basis:
- animal: 13096
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score for 24, 48 and 72 hr is 0
- Irritation parameter:
- edema score
- Basis:
- animal: 13097
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score for 24, 48 and 72 hr is 0
- Irritation parameter:
- edema score
- Basis:
- animal: 13098
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score for 24, 48 and 72 hr is 0
- Irritant / corrosive response data:
- Individual Skin Irritation Scores and Mean Score by Time-point
Erythema/Edema Scores
Animal No. Sex Hours After Patch Removal
1 24 48 72
13096 F 1/0 0/0 0/0 0/0
13097 F 1/0 0/0 0/0 0/0
13098 F 1/0 0/0 0/0 0/0
Total 3/0 0/0 0/0 0/0
Mean 1.0/0.0 0.0/0.0 0.0/0.0 0.0/0.0
Any other information on results incl. tables
Erythema/Edema Overall Mean Scores by Animal
Animal No. |
Sex |
Hours After Patch Removal |
Mean Score for 24, 48 and 72 hour Time-point |
||
24 |
48 |
72 |
|||
13096 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
13097 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
13098 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
SUMMARY OF PRIMARY SKIN IRRITATION SCORES1
|
Hours |
|||
|
1 |
24 |
48 |
72 |
Erythema |
1.0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
TOTAL (PDI)2 |
1.0 |
0 |
0 |
0 |
Primary Dermal Irritation Index (PDII): PDI for l, 24, 48 and 72 hours/4= 0.3
1Average values for three rabbits.
2PDI = Average Erythema + Average Edema
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- Under the conditions of this study, Spectrace MD-8 10 Marker (Solvent Free) caused only very slight irritation which was resolved by 24 hrs. Therefore, this material would not be classified as a skin irritant under EU GHS criteria.
- Executive summary:
A primary skin irritation test was conducted with rabbits to determine the potential for Spectrace® MD-810 Marker (Solvent
Free) to produce irritation after a single topical application.
Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits
for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.
All animals appeared active and healthy. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. There was no edema observed at any treated site during this study. One hour after patch removal, all three treated sites
exhibited very slight erythema. All animals were free of dermal irritation by 24 hours. The Primary Dermal Irritation Index (PDII) calculated for this test substance was 0.3.
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