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EC number: 464-700-1 | CAS number: 607724-42-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Mar. 22, 2005 to Apr. 29, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 464-700-1
- EC Name:
- -
- Cas Number:
- 607724-42-5
- Molecular formula:
- Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na
- IUPAC Name:
- pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red F01-0481
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 2.2–2.9 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff® K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week under study conditions
- Temperature: 18±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From Mar. 22, 2005 to Apr. 29, 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg
VEHICLE
- Amount applied: 0.3 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 h after removal of the patches. Because of persistent irritations 72 h after removal of the patches, additional readings were performed after 7 d with one animal. First animal exposed which had servere test item related skin discoloration was observed until the discoloration had disappeared (Day 15) to assess reversibility of discoloration.
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Preparaton of test site: About 24 h before the start of the study the hair in the dorsal region of the body of the 4 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: Warm tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Overall study design:
An initial test was performed using one animal. As no corrosive effects were observed in the initial test a confirmatory test with two further animals was conducted at first. A 4th animal had to be used for valid assessment because one animal was not assessable for erythema in the first study week due to test substance related discolorations. About 24 h before the start of the study the hair in the dorsal region of the body of the 4 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.
Each animal was treated with 0.5 g of test substance formed into a paste-like consistency with 0.3 mL of deionized water.The test substance was evenly distributed over the whole surface of a 2.5x2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 h. After the exposure period, all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30-60 minutes as well as 24, 48 and 72 h after removal of the patches. Because of persistent irritations 72 h after removal of the patches, additional readings were performed after 7 d with one animal. First animal which showed severe test substance related skin discoloration was observed until the discoloration had disappeared (Day 15) to assess reversibility of discoloration. Erythema, eschar formation and edema were evaluated numerically according to the score of Draize. All other changes of the skin were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
Any other information on results incl. tables
One (1st) animal was not assessable for erythema in the first study week because of test substance related skin discoloration. Therefore, a 4thanimal was treated in addition to the remaining animals. 1st animal was not included in overall assessment.
30-60 minutes up to 24 or 72 h after decontamination the animals 2ndand 4thshowed sporadically very slight up to well-defined erythema. In case of 2ndanimal, erythema was not assessable due to the discoloration caused by the test item 30-60 minutes after decontamination.
Very slight up to slight edema were observed 24 h up to 72 h after decontamination in second animal. Additionally, the skin surface of the 2ndanimal was dry, rough and scaled. 7 d after decontamination the irritations were reversed. 3rd animal showed no irritations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was found to be non-irritating to skin.
- Executive summary:
A study was conducted to assess the skin irritation potential of the test substance in New Zealand White rabbits according to EU Method B.4 and OECD Guideline 404, in compliance with GLP.
0.5 g of test substance was mixed with 0.3 mL of deionized water to form a paste-like consistency and applied as a single dose on the clipped dorsal surface of the test animals. As no corrosive effects were observed in the initial test, a confirmatory study with two further animals was conducted. A 4thanimal had to be added because one animal was not assessable for erythema in the first study week due test substance-related discoloration. The substance was evenly distributed over a surface of 2.5 x 2.5 cm using a semi-occlusive patch. The substance was washed with warm water after a 4 h exposure period. Examinations of the skin took place 30-60 minutes as well as 24, 48 and 72 h after removal of the patches. Because of persistent irritation 72 h after patch removal, additional readings were performed after 7 d with one animal. The animal which showed severe skin discoloration was observed until this had disappeared (Day 15). Erythema, eschar formation and edema were evaluated according to the score of Draize.
No clinical signs of systemic toxicity were observed. From 30-60 minutes up to 24 or 72 h after washing, two animals showed sporadically very slight up to well-defined erythema. Additionally, the skin surface was dry, rough and scaled. 7 d after washing, the irritation was reversed. A third animal showed no irritation.
Under the conditions of the study, the test substance was found to be non-irritating to skin.
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