Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 415-510-2 | CAS number: 145703-76-0
- 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 / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2 to 10 December, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Version / remarks:
- (1991)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Red GS 3848
- IUPAC Name:
- Red GS 3848
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test animalsAge at study initiation: 14 weeksWeight at study initiation: 2.7 kg (males), 2.8 kg (females)Housing: individually in cagesDiet: ad libitumWater: ad libitumAcclimation period: 4 days under test conditions after health examination. Only animals without any visual signs of illness were used for the study.Environmental conditions:Temperature: 20 ± 3 °CHumidity: 40 - 70 %Air changes: 10 - 15 per hourPhotoperiod: 12 hours artificial fluorescent light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Amount applied: 0.5 g of test substance slightly moistened with bi-distilled water.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours after the removal of the dressing.
- Number of animals:
- 1 male and 2 females.
- Details on study design:
- Test siteArea of exposure: 100 cm2Coverage: 6 cm2Type of wrap if used: patch of surgical gauzeRemoval of test substanceWashing: lukewarm-tap waterTime after start of exposure: 4 hoursScoring systemErythema and eschar formation:No erythema: 0 Very light erythema (barely perceptible): 1Well defined erythema: 2Moderate to severe erythema: 3Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Maximum possible score: 4Edema formationNo edema: 0Very slight edema (slightly perceptible): 1Slight edema (edges of area well-defined by definite raising): 2Moderate edema (raised approximately 1mm): 3Severe edema (raised more than 1 mm and extending beyond area of exposure): 4Maximum possible score: 4Maximum cumulative score: 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- < 2.3
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- < 2.3
- Other effects:
- Clinical signs and mortalityNo systemic symptoms were observed in the animals during exposure and observation period and no mortality occurred.ColorationIn the area of application pink staining of the treated skin by test article was observed during the whole observation period.Body weightsOne female lost weight during the acclimation period. The body weight gain of the other animals was not affected during the study.
Any other information on results incl. tables
animal | mean 24 - 72 hours | |
erythema | edema | |
male | 0.0 | 0.0 |
female 1 | 0.0 | 0.0 |
female 2 | 0.0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- According to the CLP Regulation (EC 1272/2008) the substance is considered as non-irritant to the skin of rabbits.
- Executive summary:
Method
Study in 1 male and 2 female rabbits by topical application of 0.5 g onto 6 cm2 intact dorsal skin. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removing the dressing.
Result
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
In the area of application, pink staining of the treated skin by the test article was observed during the whole observation period.
However the staining had no influence on the evaluation of skin reactions. No corrosive effect occurred on the treated skin of any animal at each measuring interval.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.