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EC number: 260-125-3 | CAS number: 56358-10-2
- 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:
- Sept - Oct 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- EC Number:
- 260-125-3
- EC Name:
- N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Cas Number:
- 56358-10-2
- Molecular formula:
- C32H37N5
- IUPAC Name:
- N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Test material form:
- solid
- Details on test material:
- Batch number ZD 00883/044. Manufactured Oct 1996
91.3% purity. Impurity is residual solvent Shellsol AB
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr K. Thomae GMBH, Biberach
- Age at study initiation: Young Adults
- Weight at study initiation: 3.5kg - 3.97kg
Animal 1: 3.50kg (Male)
Animal 2: 3.95 kg (Male)
Animal 3: 3.97kg (Male)
- Housing: 1 animal per cage. Stainless steel wire mesh. Floor area 3000cm2. No bedding in the cages, sawdust in waste trays.
- Diet: Kliba-Labordiaet, Klingentalmuehle AG, Switzerland. About 350g per animal per day.
- Water: About 250mL tap water per animal per day
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5ml applied in a patch 2.5cm x 2.5cm. The substance was heated to 90C and cooled to body temperature before application,
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days. After the 4 hour exposure period, the test substance was removed with a Polyethylene glycol/water solution. Oberservations were made at the following intervals after removal of the patch:
1 hour
24 hours
48 hours
72 hours
8 days
15 days
A check for dead animals was made at least once a day. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Upper third of the back or flanks
- 0.5mls of substance, covering an area 2.5cm x 2.5cm
- Type of wrap: Semiocclusive; Idealbinde.
REMOVAL OF TEST SUBSTANCE
- Washing: With a Polyethylene Glycol (Lutrol E400) and water mix (2:1)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour
24 hours
48 hours
72 hours
8 days
15 days
In Animal 1, a cross incision of the treated skin was peformed after the animal was killed at study termination. Additional histopathological examination was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks on result:
- not determinable
- Remarks:
- Could not be read because of staining due to the colour of the test substance
Any other information on results incl. tables
Individual observations taken for each animal are tabulated below:
Time of observation |
Animal number
|
Erythema score |
Edema score
|
Comments on symptoms
|
1 hour
|
1 |
- |
3 |
Index for Erythema could not be read because of staining due to the colour of the test substance |
2 |
- |
2 |
||
3 |
- |
1 |
||
24 hours |
1 |
- |
4 |
Index for Erythema could not be read because of staining due to the colour of the test substance |
2 |
- |
4 |
Index for Erythema could not be read because of staining due to the colour of the test substance. Index for Erythema of the surrounding area: 3 |
|
3 |
- |
2 |
||
48 hours |
1 |
- |
3 |
Index for Erythema could not be read because of staining due to the colour of the test substance. Index for Erythema of the surrounding area: 2 |
2 |
- |
3 |
||
3 |
- |
2 |
||
72 hours |
1 |
- |
3 |
Superficial scabbing. Index for Erythema could not be read because of staining due to the colour of the test substance. Index for Erythema of the surrounding area: 2 |
2 |
- |
2 |
Superficial scabbing. Index for Erythema could not be read because of staining due to the colour of the test substance. Index for Erythema of the surrounding area: 1 |
|
3 |
- |
1 |
Index for Erythema could not be read because of staining due to the colour of the test substance. Index for Erythema of the surrounding area: 1 |
|
8 days |
1 |
0 |
2 |
Superficial scabbing. Application area reddish discoloration. |
2 |
- |
1 |
Superficial scabbing. Index for Erythema could not be read because of staining due to the colour of the test substance |
|
3 |
- |
1 |
||
15 days |
1 |
0 |
3 |
Gross Examination of the skin. |
2 |
- |
1 |
Index for Erythema could not be read because of staining due to the colour of the test substance |
|
3 |
- |
1 |
Superficial scabbing. Index for Erythema could not be read because of staining due to the colour of the test substance |
|
Mean |
1 |
- |
3.3 |
|
2 |
- |
3.0 |
|
|
3 |
- |
1.7 |
|
|
Overall Mean |
|
2.7 |
|
|
Note for the calculation of the mean, only the results at 24, 48 and 72 hours are used.
PATHOLOGICAL-ANATOMICAL EVALUATION:
Skin, Left Flank: In the area of application surface raised, palpatory slight thickening of tissue.
HISTO-PATHOLOGICAL EXAMINATION:
Skin, Left Flank: Minimal Infiltration with neutrophile Granulocyte.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance gave a mean Edema score of 2.7 and based on the observations in this test should be classified according to EU criteria as Skin Irritant Category 2.
- Executive summary:
The skin irritation potential of the test material was evaluated in this study with New Zealand White rabbits. One group of three rabbits received a volume of 0.5 ml of the test substance applied in a patch 2.5cm by 2.5cm. on the upper third of the back or the flanks. The fur was removed by clipping. The material was first heated to 90C, then cooled to body temperature for application. Following the application, each site was covered with a semiocclusive dressing. Four hours post-dose, the dressings were removed. The exposure sites were cleaned to remove as much non-absorbed test article as possible. The exposure sites were examined and scored separately for both erythema and edema at the following time periods after removal of the patch: 1h, 24h, 48h, 72h, 8d and 15d.
The evaluation of erythema was not possible, because the test substance caused red coloration of skin. The mean edema score was 2.7 and the findings were not reversible after 15 days. Pathological-Anatomical examination of 1 animal in the area of application showed surface raised, palpatory slight thickening of tissue. The Histopatholoogical examination showed minimal infiltration with neutrophil granulocyte.
Based on these observations and the edema score, the substance should be classified according to EU criteria as Skin Irritant Category 2.
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