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EC number: 296-120-8 | CAS number: 92257-31-3
- 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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology was equivalent or similar to OECD 404 and in accordance with the Principles of Good Laboratory Practice (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not Applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.
- EC Number:
- 296-120-8
- EC Name:
- 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.
- Cas Number:
- 92257-31-3
- Molecular formula:
- Not applicable
- IUPAC Name:
- 2-Naphthalenol, 1-[2-[4-(2-phenyldiazenyl)phenyl]diazenyl]-, ar-heptyl ar',ar''-Me derivatives *
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Source: New York State Rabbit Development, Hartwick, N.Y.
-Weight at Initiation: Approximately 2-4kg
-Identification: Ear tag, Cage tab
-Housing: Individually housed in wire mesh bottom cages
-Diet: HIH Animal Feed A, certified feed, ad libitum. Supplied fresh daily.
-Water: Tap wate, ad libitum.
-Quarantine: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
-Temperature: as per "Guide for the care and use of Laboratory Animals"
-Humidity: as per "Guide for the care and use of Laboratory Animals"
-Air Changes (per hour): 12-15 air changes/hour
-Photoperiod (hrs dark/hrs light): 12 hours light/dark cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of Automate Red B nonvolatile
- Duration of treatment / exposure:
- Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible.
- Observation period:
- One-half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours.
- Number of animals:
- 6 rabbits
- Details on study design:
- Animals will be weighted and the weights recorded prior to the initiation of the study. Approximately 24 hours prior to dosing, the fur shall be clipped from the back and flanks of each animal. Just prior to application of the test article the right dorsal side of each animal will be abraded with the point of a 22 guage clean hypodermic needle. The abrasions will penetrate the stratum corneum but will not be deep enough to disturb the dermis or cause bleeding. The test article will be applied to each of the to sites per animal, one on abraded skin and the other on intact skin. All sites will have an area of one square inch. If necessary, a glass rod will be used to evenly distribute the test article. Each test site shall be occluded with a one square inch gauze patch, two single layers thick, held on with masking tape and the area subsequently secured by a nonabsorbant binder according to FDRL's Standard Operating Procedures. The binders will be left on the animals for 4 hours follwoing application of the test article. At that time, the binders will be removed and the test areas gently wiped using a soft clean gauze. Skin sites will be examined at 30-60 minutes, and then at 24, 48, and 72 hours after patch removal. Erythema and edema will be scored individually and evaluated according to the method of Draize, 1965.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72, and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for intact skin
- Irritation parameter:
- edema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72, and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for intact skin
- Irritation parameter:
- erythema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72 and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for abraded skin
- Irritation parameter:
- edema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72 and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for abraded skin
- Irritant / corrosive response data:
- non-irritating
- Other effects:
- None
Any other information on results incl. tables
Based on the individual animal mean score for the 24.5, 48 and 72 hr time-point for each parameter (Erythema and Eschar Formation and Edema Formation) on intact skin, this material would not be classified under EU regulations.
|
|
|
Rabbit Number |
|||||
Parameter scored |
Exposure Time (hours) |
Skin |
1116 |
1117 |
1118 |
1119 |
1121 |
1122 |
Erythema and Eschar Formation |
24.5 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean score for 24.5, 48 and 72 h time-point |
0 |
0 |
0 |
0 |
0 |
0 |
||
(A)Erythema and Eschar Sub-total |
|
|
0 |
0 |
0 |
0 |
||
Edema Formation |
24.5 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean score for 24.5, 48 and 72 h time-point |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material is non-irritating.
- Executive summary:
The skin irritation potential of the test material was evaluated in 6 New Zealand rabbits. A single dermal application of 0.5 ml of undiluted test material was applied to the abraded and intact skin of the rabbits under an occlusive wrap. Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible. One-half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours. Based on the results of the study, the test material is considered to be non-irritating.
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