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EC number: 204-896-6 | CAS number: 128-58-5
- 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
Not irritating to skin or eyes
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:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.4
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Code of Federal Regulations, Title 16, Section 1500.41.
Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped Free of heir. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 milliliter (in case of Liquids ) or 0.5 gram ( in case of solids and semisolids ) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated on the basis of the Draize scores. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded (3x3 cm) and shaved (3x3 cm) skin
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- pasted
- Amount / concentration applied:
- 5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM: Code of Federal Regulations, Title 16, Section 1500.41
Erythema and eschar formation (EEF) : Value*
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation (EF):
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4
*The "value" recorded for each reading is the average value of the six or more animals subject to the test.
Readings are again mode at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are mode an areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and at 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and 72 hours for intact skin to the values an abraded skin at 24 hours and 72 hours (four values). Similarly, add the values for oedema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score.
Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4
ECLASSIFICATION SYSTEM FOR PRIMARY IRRITATION
From “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics",
published by the Association of Food and Drug Officials of the United States, 1959, page 46.
"Compounds producing combined averages (primary irritation indices) of 2 or less are only mildly irritating; whereas those with indices from 2 to 5 are moderate irritants, and those with scares above 6 are considered severe irritants." - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 + 72 h
- Score:
- 0.01
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- shaved skin
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- shaved skin
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema with very slight oedema was observed in one abraded site at the 24 hours reading.
Five animals did not show any observable response to treatment throughout the 72 hours observation period.
The primary Irritation was calculated to be : 0.1 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- FDA Federal Register 38, No 187, Patch-Test, occusive scarified and intact skin
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded (3x3 cm) and shaved (3x3 cm) skin
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- pasted
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM: FDA Federal Register 38, No 187
Erythema and eschar formation (EEF) :
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation (EF):
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4
Mean value of 6 animals
Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4
EVALUATION:
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 + 72 h
- Score:
- 0.06
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- exact erythema evaluation not possible due to skin staining
- Interpretation of results:
- other:
- Remarks:
- not irritating
- Conclusions:
- not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- BASF-Testing method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Amount / concentration applied:
- Concentration: 50% aqueous paste
- Duration of treatment / exposure:
- Back: 20 hours
- Observation period:
- 24 hours, 8 days
- Number of animals:
- no data
- Details on study design:
- TEST SITE
- Area of exposure: back and ear
- % coverage: -
- Type of wrap if used: -
SCORING SYSTEM:
Erythema and Edema
Ø - no effect
(+) - questionable
+ - mild
++ - moderate
+++ - marked
N - necrosis
Sch - scabbing
Na - scar - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- slight reddening after 24 hours, no effects after 8 days
- Other effects:
- yellow remainder of test item visible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating
Referenceopen allclose all
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:
- weight of evidence
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER; OFFENBACH / MAIN, Germany
- Weight at study initiation: 1 male: 2.87 kg; 2 females: 2.85 kg
- Housing: single
- Diet: OVATOR SOLIKANIN 4 MM; MUSKATOR-WERKE DUESSELDORF; Germany; ca 130 g/animal/day
- Water: tap water; ca. 250 mL/animal/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 June 1984 To: 27. June 1984 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL bulk volume (ca. 65 mg test substance)
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: NA
SCORING SYSTEM: Draize
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Vat Green 1 is not irritating to eyes
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The Consumer Product Safety Commission of the U. S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
- Principles of method if other than guideline:
- Code of Federal Regulations, Title 16, Section 1500.42
Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained as to exclude sawdust, wood chips, or other extraneous materials that might produce eye Irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by-gently pulling the lower lid away from the eyeball to forma cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control. For testing liquids, 0.1 millilitre is used. For solids or pastes, 100 milligram of the test substance is used, except that for substances in flake, granule, powder, or other particulate form the amount that has a volume of 0.1 millilitre (after compacting as much as possible without crushing or altering the individual particles, such as by, tapping the measuring container) shall be used whenever this volume weighs less than 100 milligram. In such a case, the weight of the 0.1 millilitre test dose should be recorded. The eyes are not washed following instillation of test material - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (47 mg)
- Concentration (if solution): NA - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours. Reading of reaction is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized in a darkened room under ultra-violet illumination. Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent after the 24 hour reading.
Scoring according to "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" (Draize) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None of the animals gave "positive" reactions
Mild conjunctival reactions only were observed in all six animals - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Caledon Green XBN Grains gave a negative test for eye irritation, according to the definition given in the Code of Federal Regulations
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Various studies for skin or eye irritating properties were conducted wit Vat Green 1. In these studies, Vat Green 1 was not irritating to skin and eyes.
Justification for classification or non-classification
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