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EC number: 277-761-2 | CAS number: 74196-18-2
- 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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- not applicable
- Remarks:
- 4-hour application
- Principles of method if other than guideline:
- The test item were applied to clipped skin of three rabbits for 4 hours and the readings were performed after 30 minutes and 24, 48 and 72 hours.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acid Black 076
- IUPAC Name:
- Acid Black 076
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Gender: male
- Housing: all animals were housed in individual cages
- Diet: a standard laboratory diet were provided ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: 15 changes/hour
- Photoperiod: the light/dark cycle was 12 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- WEM
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 1 ml
- Preparation: diluted with WEM - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes, 24, 48 and 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: back of the animals
- Preparation: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries
- Area of coverage: 6.5 cm²
- Type of wrap if used: surgical gauze
- Other: the animals were immobilised with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve for the 4 hour exposure
SCORING SYSTEM
Erythema and Edema:
0 - No finding
1 - Barely perceptible effect
2 - Slight, well defined effect
3 - Moderate
4 - Severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: intact skin
Any other information on results incl. tables
Table 1: Results.
Animal no. | Symptom | 30 minutes | 24 hours | 48 hours | 72 hours |
no. 4 (male) | Erythema intact skin | 0 | 0 | 0 | 0 |
Oedema intact skin | 0 | 0 | 0 | 0 | |
no. 5 (male) | Erythema intact skin | 0 | 0 | 0 | 0 |
Oedema intact skin | 1 | 1 | 0 | 0 | |
no. 6 (male) | Erythema intact skin | 0 | 0 | 0 | 0 |
Oedema intact skin | 1 | 1 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) no. 1272/2008
- Conclusions:
- The test item was found to be not irritating to rabbit skin in vivo
- Executive summary:
The skin irritation potential of the test item was evaluated in an in vivo experimental study equivalent to the OECD Guideline 404 (1987). 1 ml of test item diluted in WEM was applied to the clipped skin of three male, New Zealand White rabbits for 4 hours using an occlusive dressing, and skin was monitored for erythema and oedema at 30 minutes, 24, 48 and 72 hours.
The mean (24/48/72 hours) erythema scores were 0 in all animals; mean (24/48/72 hours) oedema scores were 0 in animal #1, and 0.33 in animals #2 and #3, and oedema was reversible within 48 hours.
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