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EC number: 916-603-5 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 404 in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Multi constituent substance
- EC Number:
- 916-603-5
- IUPAC Name:
- Multi constituent substance
- Details on test material:
- Test substance : Basic Red 76 (COLIPA number C008)
Batch number : 0050644101
Methylsulphate anion : 11.8%
Chloride ion : 1.6%
Water : 5.1%
o-Anisidine : 5ppm
Purity : 98.1% (HPLC)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: test item moistened with water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- Three
- Details on study design:
- The dorsal fur was clipped approximately 24 hours prior to treatment to expose an area of ~150cm2. The intact clipped back skin of each animal was exposed to 500mg of the test item moistened with water. The test item was placed on a surgical gauze patch (~16cm2). The patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The patch was removed after 4 hours of semi-occlusive contact and the skin was flushed with lukewarm tap water to clean the application site. The animals were examined for signs of erythema, eschar and oedema formation approximately 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item. The skin reaction was assessed according to the numerical scoring system listed in the EEC Directive 92/69/EEC.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours, 7,10, 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours, 7,10, 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours, 7,10, 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours, 7,10, 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours, 7,10, 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours, 7,10, 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No visible signs of irritation were observed. Slight red staining was observed in all animals from 1 hour after exposure up to 72 hours after treatment. Staining persisted in one animal up to a 14-day examination. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for edema grades separately. The mean erythema/eschar score and the mean edema score was 0.0 for all three animals. No erythema and no swelling (edema) was noted in any animal at any time. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD guideline 404. The test item was applied by topical semi-occlusive application of 0.5g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of the treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for edema grades separately. The mean erythema/eschar score and the mean edema score was 0.0 for all three animals. The application of the test item to the skin resulted in no signs of irritation. Slight red staining was observed in all animals from the 1 hour reading up to 72 hours after treatment and persisted in one animal up to the 14 -day examination, the end of the observation period for all animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. The test item did not induce significant or irreversible damage to the skin. Based upon the referred classification criteria the test item is considered to be not irritating to rabbit skin.
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