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Diss Factsheets
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EC number: 215-863-0 | CAS number: 1435-71-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(o-nitrophenyl)azo]-p-cresol
- EC Number:
- 215-863-0
- EC Name:
- 2-[(o-nitrophenyl)azo]-p-cresol
- Cas Number:
- 1435-71-8
- Molecular formula:
- C13H11N3O3
- IUPAC Name:
- 4-methyl-2-[(2-nitrophenyl)diazenyl]phenol
- Details on test material:
- - Identification: TKA 40136
- Product name: Monoazo 3113
- Physical state: Red-brownish solid
- Analytical purity: > 95%
- Lot/batch No.: Pa 369
- Expiration date of the lot/batch: November 01, 1997
- Stability under storage conditions: stable
- Stability in vehicle (water): not known
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, Netherlands
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 1563 - 1788 grams
- Housing: single
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, Netherlands), approximately 100 gram per day; in addition, hay (BMI, Helmond, Netherlands) was provided once a week;
- Water: Free access to tap-water diluted with decalcified water;
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: A pre-test revealed that the test substance was hydrophobic. Therefore the skin of the animals was moistened with distilled water, to ensure close contact of the test substance to the skin.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approximately 150 square centimeters (10x15 cm2)
- Type of wrap if used: Scotchpak-non-woven patch of 2x3 cm mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage (3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD 404 / Draize; the calculation of the primary irritation index is based on Draize et.al. (1944), J.Pharmacol.Exp. 82, 377
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: No erythema score available 1 hour after exposure due to brown/red staining. Erythema (score 1) in all animals 24 hours after the exposure (reversible within 24 hours). See table below for details.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: Edema (score 1) in 1 animal 1 hour after exposure (reversible within 24 hours). See table below for details.
- Irritant / corrosive response data:
- Brown/red staining of the treated skin by the test substance was observed during the observation period, and prevented scoring for erythema at 1 hour post exposure.
- Other effects:
- No signs of systemic intoxication were observed during the study period.
Any other information on results incl. tables
Exposition: | 4 h | |||
Animal | Reading | Erythema | Edema | Symptoms |
1 | 1 h | / | 1 | No erythema score possible due to brown/red staining. |
2 | 1 h | / | 0 | No erythema score possible due to brown/red staining. |
3 | 1 h | / | 0 | No erythema score possible due to brown/red staining. |
1 | 24 h | 1 | 0 | Brown/red staining of skin by test substance. |
2 | 24 h | 1 | 0 | Brown/red staining of skin by test substance. |
3 | 24 h | 1 | 0 | Brown/red staining of skin by test substance. |
1 | 48 h | 0 | 0 | Brown/red staining of skin by test substance. |
2 | 48 h | 0 | 0 | Brown/red staining of skin by test substance. |
3 | 48 h | 0 | 0 | Brown/red staining of skin by test substance. |
1 | 72 h | 0 | 0 | Brown/red staining of skin by test substance. |
2 | 72 h | 0 | 0 | Brown/red staining of skin by test substance. |
3 | 72 h | 0 | 0 | Brown/red staining of skin by test substance. |
Mean (animal 1) | 24 - 72 h | 0.3 | 0.0 | |
Mean (animal 2) | 24 - 72 h | 0.3 | 0.0 | |
Mean (animal 3) | 24 - 72 h | 0.3 | 0.0 | |
mean | 24 - 72 h | 0.3 | 0.0 |
Dermal application of the test substance resulted in a primary irritation index of 0.5 (mildly irritating) when applied to the intact rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered not irritant to skin.
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