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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- 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.
- 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. - 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals and Animal Care:
Six 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 "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. The rabbits were individually housed in wire mesh bottom cages in an environment-controlled room and provided NIH Animal Feed A (certified) and water ad libitum. Animals were identified with ear tags and color coded cage cards and acclimated for a minimum of 5 days prior to study initiation. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye served as control.
- Amount / concentration applied:
- 0.1 ml of undiluted material was applied to the eye of the rabbit. The other eye served as the untreated control.
- Duration of treatment / exposure:
- Single exposure. Eyes are not irrigated after test article installation.
- Observation period (in vivo):
- The treated eyes were examined with the aid of sodium fluorescin and the grade of ocular reaction was recorded for all animals at 1, 24, 48, 72 and 96 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 days thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The treated eyes were examined with the aid of sodium fluorescin and the grade of ocular reaction was recorded for all animals at 1, 24, 48, 72 and 96 hours using the Draize Scale for Scoring Ocular Lesions.
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- All animals were clear of effects on corneal opacity, iris, redness or chemosis at the 24 hr time-point and thereafter.
- Executive summary:
The primary ocular irritation potential of Fluorescent Yellow #131 was evaluated in this study with New Zealand White rabbits. One group of six albino rabbits received a single, unwashed exposure. Each 0.1- ml dose of the test article was instilled into the lower conjunctival sac of one eye. The other eye served as an untreated control. The eyes were examined for ocular reactions in accordance with the method of Draize at 1, 24, 48 and 72 hours after dosing. All animals were free of effects on corneal opacity, iris, redness and chemosis at the 24 hr timepoint and thereafter.
Reference
Individual Rabbit Eye Irritation Scores
|
|
|
Reading |
|||
Rabbit Number |
Item |
Tissue |
1 hr |
24 hr |
48 hr |
72 hr |
3149 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
1 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
4 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
4 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3150 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
2 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3152 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3154 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
2 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3155 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
2 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3156 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
1 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
4 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
4 |
0 |
0 |
0 |
Initial Body Weights:
Animal Number Initial Body Weight (kg)
83 -3149 2.18
83 -3150 2.20
83 -3152 2.58
83 -3154 2.48
83 -3155 2.60
83 -3156 2.32
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
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.
Eye irritation
The primary ocular irritation potential of Fluorescent Yellow #131 was evaluated in this study with New Zealand White rabbits. One group of six albino rabbits received a single, unwashed exposure. Each 0.1- ml dose of the test article was instilled into the lower conjunctival sac of one eye. The other eye served as an untreated control. The eyes were examined for ocular reactions in accordance with the method of Draize at 1, 24, 48 and 72 hours after dosing. All animals were free of effects on corneal opacity, iris, redness and chemosis at the 24 hr timepoint and thereafter.
Justification for classification or non-classification
Criteria for classification are not met.
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