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EC number: 296-120-8 | CAS number: 92257-31-3
- 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
Reliable skin irritation (in vivo) and eye irritation (in vivo) studies using rabbits are available
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology was equivalent or similar to OECD 404 and in accordance with the Principles of Good Laboratory Practice (GLP)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not Applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Source: New York State Rabbit Development, Hartwick, N.Y.
-Weight at Initiation: Approximately 2-4kg
-Identification: Ear tag, Cage tab
-Housing: Individually housed in wire mesh bottom cages
-Diet: HIH Animal Feed A, certified feed, ad libitum. Supplied fresh daily.
-Water: Tap wate, ad libitum.
-Quarantine: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
-Temperature: as per "Guide for the care and use of Laboratory Animals"
-Humidity: as per "Guide for the care and use of Laboratory Animals"
-Air Changes (per hour): 12-15 air changes/hour
-Photoperiod (hrs dark/hrs light): 12 hours light/dark cycle - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of Automate Red B nonvolatile
- Duration of treatment / exposure:
- Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible.
- Observation period:
- One-half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours.
- Number of animals:
- 6 rabbits
- Details on study design:
- Animals will be weighted and the weights recorded prior to the initiation of the study. Approximately 24 hours prior to dosing, the fur shall be clipped from the back and flanks of each animal. Just prior to application of the test article the right dorsal side of each animal will be abraded with the point of a 22 guage clean hypodermic needle. The abrasions will penetrate the stratum corneum but will not be deep enough to disturb the dermis or cause bleeding. The test article will be applied to each of the to sites per animal, one on abraded skin and the other on intact skin. All sites will have an area of one square inch. If necessary, a glass rod will be used to evenly distribute the test article. Each test site shall be occluded with a one square inch gauze patch, two single layers thick, held on with masking tape and the area subsequently secured by a nonabsorbant binder according to FDRL's Standard Operating Procedures. The binders will be left on the animals for 4 hours follwoing application of the test article. At that time, the binders will be removed and the test areas gently wiped using a soft clean gauze. Skin sites will be examined at 30-60 minutes, and then at 24, 48, and 72 hours after patch removal. Erythema and edema will be scored individually and evaluated according to the method of Draize, 1965.
- Irritation parameter:
- erythema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72, and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for intact skin
- Irritation parameter:
- edema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72, and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for intact skin
- Irritation parameter:
- erythema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72 and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for abraded skin
- Irritation parameter:
- edema score
- Remarks:
- 6 rabbits
- Basis:
- mean
- Remarks:
- 0.0
- Time point:
- other: 24.5, 48, 72 and 96 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results for abraded skin
- Irritant / corrosive response data:
- non-irritating
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material is non-irritating.
- Executive summary:
The skin irritation potential of the test material was evaluated in 6 New Zealand rabbits. A single dermal application of 0.5 ml of undiluted test material was applied to the abraded and intact skin of the rabbits under an occlusive wrap. Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were 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 separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours. Based on the results of the study, the test material is considered to be non-irritating.
Reference
Based on the individual animal mean score for the 24.5, 48 and 72 hr time-point for each parameter (Erythema and Eschar Formation and Edema Formation) on intact skin, this material would not be classified under EU regulations.
|
|
|
Rabbit Number |
|||||
Parameter scored |
Exposure Time (hours) |
Skin |
1116 |
1117 |
1118 |
1119 |
1121 |
1122 |
Erythema and Eschar Formation |
24.5 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean score for 24.5, 48 and 72 h time-point |
0 |
0 |
0 |
0 |
0 |
0 |
||
(A)Erythema and Eschar Sub-total |
|
|
0 |
0 |
0 |
0 |
||
Edema Formation |
24.5 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean score for 24.5, 48 and 72 h time-point |
0 |
0 |
0 |
0 |
0 |
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to OECD TG 405 and in accordance with the Principles of Good Laboratory Practice (GLP)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals:
-Source: New York State Rabbit Development, Hartwick, N.Y.
-Weight at study initiation: Approximately 2-4kg
-Housing: Individually housed in wire mesh bottom cages
-Food: NIH Animal feed A, ad libitum
-Water: Tap water, ad libitum
-Acclimation period: minimum of 5 days
Environmental Conditions
-Temperature (C): as per "Guide for the Care and Use of Laboratory Animals"
-Humidity (%): as per "Guide for the Care and Use of Laboratory Animals"
-Air Changes (per hr): 12-15 air changes/hour
-Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye for each animal served as untreated control.
- Amount / concentration applied:
- A volume of 0.1 ml instilled in the everted lower lid of one eye of each animal. The other eye served as the untreated control.
- Duration of treatment / exposure:
- The lids of the treated eyes of the animals were held closed for one second following instillation and were not irrigated. The animal was then returned to it's cage.
- Observation period (in vivo):
- Observations for eye irritation were made at 1, 24, 48, and 72 hours and again at 7 days after application of the test article.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Method:
Animals wiil be weighed and weights recorded prior to the initiation of the study.
Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those
rabbits whose eyes were free of irritation and corneal lesions were used.
A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated.
With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. If injury persisted the eyes were further examined and scored every 3 days for 13 days or until all signs of reversible irritation subsided.
Test Article Classification:
The mean eye irritation score and the standard deviation of the mean were determined for each observation period. The greatest mean score observed was used to assign the test article an ocular irritation rating in accordance with the classification system of Draize. - 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
- Irritant / corrosive response data:
- See results section.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material is not considered corrosive to the eyes of rabbits.
- Executive summary:
The eye irritation potential of the test material was evaluated in 6 New Zealand White rabbits. Animal body weights were recorded prior to the initiation of the study. Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those rabbits whose eyes were free of irritation and corneal lesions were used. A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated. With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. Under the conditions of the study, The test material is not considered corrosive to the eyes of rabbits.
Reference
Individual Rabbit Eye Irritation Scores
|
|
|
Reading |
||||
Rabbit Number |
Item |
Tissue |
1 hr |
24 hr |
48 hr |
72 hr |
Day 7 |
0906NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0874NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0875NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0877NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0878NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0799NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
Initial Body Weights:
Animal Number Initial Body Weight (kg)
82 -0906 M 2.70
82 -0874 M 2.85
82 -0875 M 2.87
82 -0877 M 2.83
82 -0878 M 2.94
82 -0799 M 2.75
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The skin irritation potential of Automate Red B Nonvolatile was evaluated in 6 New Zealand rabbits. A single dermal application of 0.5 ml of undiluted test material was applied to the abraded and intact skin of the rabbits under an occlusive wrap. Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were 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 separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours. Based on the results of the study, the test material is considered to be non-irritating.
Eye Irritation:
The eye irritation potential of Automate Red B Nonvolatile was evaluated in 6 New Zealand White rabbits. Animal body weights were recorded prior to the initiation of the study. Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those rabbits whose eyes were free of irritation and corneal lesions were used. A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated. With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. Under the conditions of the study, Automate Red B Nonvolatile is not considered corrosive to the eyes of rabbits.
Justification for classification or non-classification
Not classified for skin or eye irritation
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