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EC number: 278-859-8 | CAS number: 78181-99-4
- 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
In two skin irritation studies, conducted each with a test item containing 50% dye stuff, no skin irritation was observed and thus it is not expected that the registered dye has any skin irritation properties. The result of the key eye irritation study, similarly conducted with a test item containing 50 % dye stuff, leads to the conclusion that the registered dye has no eye irritation properties.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Weight at study initiation: mean males: 2.54 kg, female 2.57 kg
- Housing: single housing in stainless steel cages with wire mesh walk floors, floor area 40 cm x 51 cm
- Diet: about 130 g/day, Kliba 341, 4 mm; Klingenthalmuehle AG, Kaiseraugst, Switzerland
- Water: about 250 mL tap water/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 rabbits (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on upper third of the back or flanks
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Treatment with the test substance resulted in erythema (score 1) in 1/3 rabbits at the 24-hour reading, which fully reversed within 48 hours. No erythema was observed in the 2 remaining rabbits. There were no edema in 3/3 rabbits.
For details, see table below. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Irritation scores:
Timepoint |
Animal No. |
Intact skin |
Symptoms |
|
Erythema |
Edema |
|
||
4 h |
1 |
0* |
0 |
Irritation index could not be read because of staining due to the color of the test substance |
2 |
0 |
0 |
|
|
3 |
0* |
0 |
Irritation index could not be read because of staining due to the color of the test substance |
|
24 h |
1 |
1 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
|
Timepoints |
|||
Mean |
1 |
0.3 |
0.0 |
24, 48, 72h |
Mean |
2 |
0.0 |
0.0 |
24, 48, 72h |
Mean |
3 |
0.0 |
0.0 |
24, 48, 72h |
Mean |
1 - 3 |
0.1 |
0.0 |
24, 48, 72h |
* if in 1 – 2 animals assessments referring to erythema cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP).
- Qualifier:
- according to guideline
- Guideline:
- other: FED. REG. 38, NO. 187, PARA. 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Weight at study initiation: mean males: 2.91 kg, female 2.85 kg
- Housing: single housing, cage area 43 cm x 51 cm
- Diet: approx. 130 g/day, Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf
- Water: approx. 250 mL/day; monday - friday VE water; saturday & sunday tap water
- Acclimation period: approx. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): approx. 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- not specified (single administration, no removal of test material by washing)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 rabbit (3 males, 3 females)
- Details on study design:
- SCORING SYSTEM:
according to Draize (APPRAISAL OF THE SAFETY OF CHEMICALS IN FOODS, DRUGS AND COSMETICS. IN: DERMAL TOXICITY PP. 46 - 59, 1959) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Conjunctival redness was the main finding after treatment with the test substance seen in all rabbits with the mean score (24, 48, 72 hours) ranging from 0.6 to 1.6. Chemosis was noted in 3/6 rabbits with a mean score of each 0.3. Effects on the iris was noted in one rabbit only (score 0.3). The findings were fully reversible within the observation period with the exeption of corneal opacity (score 1) seen in 1/6 rabbits on day 8.
For details, see table below. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Irritation scores:
Timepoint |
Animal No. |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
24 h |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
1 |
|
3 |
0 |
0 |
0 |
2 |
0 |
1 |
|
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
5 |
0 |
0 |
0 |
2 |
0 |
0 |
|
6 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
5 |
0 |
0 |
0 |
2 |
1 |
1 |
|
6 |
0 |
0 |
0 |
2 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
0 |
0 |
0 |
1 |
0 |
1 |
|
5 |
0 |
0 |
0 |
1 |
0 |
1 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
1 |
3 |
0 |
0 |
0 |
0 |
|
Mean 24h, 48h, 72h |
0 |
0 |
0.06 |
1.1 |
0.17 |
0.44 |
Mean (24h,48h,72h) |
Cornea Opacity |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
Animal 1 |
0 |
0 |
0.6 |
0.3 |
Animal 2 |
0 |
0.3 |
1 |
0.3 |
Animal 3 |
0 |
0 |
1.3 |
0 |
Animal 4 |
0 |
0 |
1 |
0 |
Animal 5 |
0 |
0 |
1.6 |
0.3 |
Animal 6 |
0 |
0 |
1 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In the key skin irritation study (BASF AG, 1988, according to OECD 404) three rabbits (2 males, 1 female) were treated once with 0.5 mL of a dye preparation via semiocclusive dermal exposure for 4 h. After exposure animals were observed for three days. Skin reactions were observed and scored according to the OECD scoring system. Thereby animals showed an average (24h, 48h, 72h) erythema scores of 0.33, 0.0 and 0.0 (animals 1, 2 and 3), respectively, which were fully reversed within the observation period. The edema score was 0 for all three animals. In conclusion, no relevant skin irritating effects were observed and thus the test material was assessed as not irritating to the skin.
In a supporting skin irritation study (BASF AG, 1982) four rabbits (3 males, 1 female) received 0.5 mL of a dye preparation via semiocclusive dermal exposure for 4 hours followed by an observation period of 8 days. Skin reactions were observed and scored according to Draize scoring system. Erythema score could not be evaluated due to coloration by the test material. No edema was observed 24h, 48h and 72h after treatment. Under the conditions of this supporting study the test material was not irritating to the rabbit skin.
Since in the underlying key skin irritation study the dye preparation was shown to be not irritatingn to the skin, even in the presence of a substantial amount of acetic acid, which is classified as skin corrosive 1B (H314) according to Regulation (EC) No 1272/2008 Annex VI Table 3.1, the registered dye, included proportionately with 50%, is not expected to possess skin irritation properties. This assumption is further substantiated by the results obtained in a supporting skin irritation study with another dye preparation containing skin corrosion-classified acetic acid to a lesser extent, and was no skin irritant. In addition, since the dye represents the highest amount in the mixture (50%), it can be concluded that the registered dye does not trigger skin irritation.
Eye irritation
In the key eye irritation study (BASF AG, 1981, according to FED. REG. 38) three male and three female Vienna White rabbits were treated once with 0.1 mL of a dye preparation by single exposure without washing of the eyes. The second eye of each animal was used as control. Eye reactions were observed and scored according to Draize 24h, 48h, 72 h and 8 days after the start of treatment. There were no cornea opacity observed after 24h, 48h and 72h. The mean (24 h, 48 h, 72 h) maxiumum values revealed 0.3 for iris score (one animal), 1.6 for conjunctivae redness (one animal) and 0.3 for conjuntivae chemosis (three animals). The effects were completely reversible after 8 days, except in one animal where mild cornea opacity (score 1) was noted after 8 days. However, as this animals showed no cornea opacity 24 h, 48 h or 72 h after treatment the effect after 8 days was considered negligible. In conclusion, the test item was not irritating to the eyes under the conditions of the study.
In an eye irritation study (BASF AG, 1988, according to OECD 405) one male rabbit was administered with 0.1 mL of a dye preparation applied to one eye of the rabbit while the other eye, remaining untreated, served as control. The test item was not removed by washing. The eye was examined 1, 24, 48, 72 h and on day 8 after treatment. The animal showed a cornea score of 2.5, an iris score of 0, a conjunctivae score of 2 and a chemosis score of 2. 8 days after reading, the irritation index for cornea and iris could not be read due to the color of the test substance and because of severe corneal opacity. The conjunctivae score and the chemosis score were not reversible within 8 days. In conclusion, the test item caused severe eye irritation under the conditions of the study.
Oppositional results were observed in the two in vivo eye irritation studies. The key eye irritation study (BASF AG, 1981) revealed no eye irritation properties when a dye preparation containing 50% dye stuff was used. The equal concentration of dye stuff was used in the second eye irritation study (BASF AG, 1988), however, this dye preparation caused severe eye irritation. This effect was considered to be caused by the high concentration of acetic acid (causes severe eye damage) and butyldiglycol (causes serious eye irritation) in the dye preparation since these substances are classified as skin corrosive cat. 1A (H 314) and eye irritating cat. 2 (H319) according to Regulation (EC) No 1272/2008 (CLP), respectively. Thus, the registered dye has to be regarded as not irritating to the eye. The eye irritation study (BASF AG, 1988) was classified as 'disregarded' for the assessment of the registered substance.
Justification for selection of skin irritation / corrosion endpoint:
most reliable study
Justification for selection of eye irritation endpoint:
most reliable study
Justification for classification or non-classification
Based on the results of the skin and eye irritation studies the test item does not need to be subjected to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).
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