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EC number: 410-070-8 | CAS number: 141880-36-6 ACID RED HT 3728; ERIONYL RED HT 3728
- 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:
- 17 July 1992 to 29 September 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- code number: FAT 45155/B
batch No.: HT 3728/ TV 1
physical appearance: powder, dark red
storage: room temperature, keep dark
expiration date: May. 15, 1997
safety precautions: gloves and face masks
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are 3 females.
TEST ANIMALS
- breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- acclimatisation period: at lease 5 days
- Weight at study initiation: 2540-2670 g
- Housing: individually in metal cages
- Feed: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): a 12 hrs light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- distilled water
- Controls:
- other: a control gauze patch was applied to the contralated flank
- Amount / concentration applied:
- 0.5 g of the test article was applied to the right flank of the shaved area. It was covered with a 12-16 cm² gauze patch. The gauze was covered with aluminium foil and held in place for 4 hours by an adhesive tape.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 females
- Details on study design:
- An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 3 6 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The application area was red-stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero.
- Other effects:
- No edema formation was observed during an observation period of 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 45155/B was found to cause no irritation when applied to intact rabbit skin.
- Executive summary:
A GLP-compliant study was performed to access the primary skin irritation potential when single doses of FAT 45155/B are placed on the skin of New Zealand White rabbits. The study was carried out according to OECD guideline 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 3 6 cm²) and held in place for 4 hours by an adhesive tape. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches. No edema formation was observed during an observation period of 7 days. The application area was red stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore, the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero. Based on the study results, FAT 45155/B can be classified as non-irritant to rabbit skin.
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