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EC number: 822-536-1 | CAS number: 2180952-76-3
- 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:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.
- EC Number:
- 270-145-4
- EC Name:
- Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.
- Cas Number:
- 68411-75-6
- Molecular formula:
- Unspecified
- IUPAC Name:
- Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Fluorescent Yellow *131, 1577-123
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Ten young adult New Zealand White rabbits were obtained from New York State Rabbit Development, Hartwick, New York for use in this study. All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEN Publication No. (NIH) 78-23. The rabbits were individually housed in wire mesh bottom cages in environment-controlled rooms and provided NIH Animal Feed A (certified) and water ad libitum. Animals were identified with ear tags and color coded cage cards. All animals were acclimated a minimum of 5 days. During this acclimation period, the rabbits were examined with respect to their general health to assure their suitability as test animals.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 2 gm/kg bw
- Duration of treatment / exposure:
- 24h
- Observation period:
- After an exposure period of 24 hours, the binders were removed. The exposure sites were then 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 spearately for both erythema and edema on a graded scale of 0 to 4 in accordance with the Skin Reaction code in Appendix 1. The exposure sites were again examined and scored at 48 and 72 hours post-dose. If irritation persisted at the 72 hour post-dose observation period, the sites were furthered examined at 4,7, 10, and 14 days post-dose or until all sites returned to normal, whichever occured first.
- Number of animals:
- 5/sex/dose
- Details on study design:
- Procedure:
On the day prior to dosing, the back and flanks of each rabbit were clipped free of fur with electric clippers. The test article was administered under an occlusive binder at a level of 2.0 g/kg body weight. The binder consisted of a layer of plastic wrap and stockinette binder, all securely held in place with masking tape. The occlusive binder was applied to maintain contact and minimize evaporation of the test article.
Observations:
After an exposure period of 24 hours, the binders were removed. The exposure sites were then 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 spearately for both erythema and edema on a graded scale of 0 to 4 in accordance with the Skin Reaction code. The exposure sites were again examined and scored at 48 and 72 hours post-dose. If irritation persisted at the 72 hour post-dose observation period, the sites were furthered examined at 4,7, 10, and 14 days post-dose or until all sites returned to normal, whichever occured first.
All animals were observed frequently on the day of dosing and twice daily for the remainder of the study. All external signs of toxicity or pharmacological effects were noted. Body weights were recorded initially, on days 8 and 15 or at death.
Necropsy:
All animals that died during the study, and all survivors at termination (day 15) were subjected to gross necropsy and abnormalities were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- The individual mean 24.5/48/72 h score for all animals on study was 0.
- Time point:
- other: 24.5/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other:
- Remarks:
- The first observation time-point post dose was actually 24.5 hr instead of 24 hr.This has no impact on the evaluation results.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- The individual mean 24.5/48/72 h score for all animals on study was 0.
- Time point:
- other: 24.5/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other:
- Remarks:
- The first observation time-point post dose was actually 24.5 hr instead of 24 hr.This has no impact on the evaluation results.
- Other effects:
- One male had soft stool and 2 other males exhibited anorexia temporarily during the study. Animals gained weight throughout the study. There were no noteworthy findings in gross pathology and there was no mortality.
Any other information on results incl. tables
Skin Irritation Scores
|
Obs. Post-dose hrs |
Rabbit Number |
|||||||||
|
Males |
Females |
|||||||||
|
3276 |
3280 |
3282 |
3283 |
3286 |
3344 |
3346 |
3358 |
3359 |
3360 |
|
Erythema |
24.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
24.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Summary of Irritation Potential |
||||||||||
Erythema sub-total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema sub-total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total for Erythema and Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Individual Animal Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean Primary Irritation Score: 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Fluorescent Yellow *131, 1577-123, was evaluated for skin irritation potential in male and female New Zealand White rabbits. The test article was applied to each of ten rabbits at a level of 2.0 g/kg body weight. All animals survived the 15 day post-dose observation period. Based on the results, the test article is considered to be non-irritating to the skin of rabbits.
- Executive summary:
Fluorescent Yellow *131, 1577-123, was evaluated for skin irritation potential in male and female New Zealand White rabbits. The test article was applied to each of ten rabbits at a level of 2.0 g/kg body weight. All animals survived the 15 day post-dose observation period. Based on the results, the test article is considered to be non-irritating to the skin of rabbits.
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