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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 426-840-1 | 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
- Study period:
- Delivery of the animals October 23, 1996 - Euthanasia of the animals October 31, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 17, 1992 (reported Paris April 29, 1993)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- July 31, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 426-840-1
- EC Name:
- -
- IUPAC Name:
- tetrasodium 7-[(2,6-difluoropyrimidin-4-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate 7-[(4,6-difluoropyrimidin-2-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- Identity: Scarlet RN 1165
Appearance : Solid powder, dark-red
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Chbb: NZW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH; Birkendorferstrasse 65; D - 88397 Biberach / Riss
- Age at treatment : 15 weeks
- Weight at study initiation:
at start of acclimatization : male 2.5 kg, females 2.5-2.6 kg
at start of treatment : male 2.7 kg, females 2.3-2.6 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet (batch 70/96) ad libitum from Kliba Muhlen AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are included in this report.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in this report.
- Acclimation period: Four days under test conditions after health examination. Only healthy animals were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): between 40-70% (values above 70% during cleaning process possible)
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light/12 hours dark, music during the light period
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.5g test item/animal (left side only)
VEHICLE
The test article was moistened with bi-distilled water before application - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removal of the dressing
- Number of animals:
- 3 young adults: 1 male (#1) and 2 females (#2, #3)
- Details on study design:
- TEST SITE
- Area of exposure: 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the clipped area
- % coverage: It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze
- Type of wrap if used: The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): h, 24h, 48h and 72 h after removal of the dressing
SCORING SYSTEM:
- Method of calculation: To classify the irritating potential of the test article, the mean values of erythema I eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Commission Directive 93/21/EEC, April 27, 1993).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: Animal : #1 (M), #2 (F) & #3 (F)
- Time point:
- other: 1h, 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant in absence of effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: Animal #1 (M), #2 (F) & #3 (F)
- Time point:
- other: 1h , 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant in absence of effects
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- IRRITATION
SCARLET RN 1165 showed a primary irritation score of 0.00, when applied to healthy intact rabbit skin.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
CORROSION
No irreversible alterations of the treated skin were observed nor were corrosive
effects evident on the skin. - Other effects:
- VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
COLORATION
Irreversible pale red staining by the test article of the treated skin was observed.
BODY WEIGHTS
The body weight gain of all rabbits was within the normal range of variability.Please refer to results in section "any other information on results incl. tables" hereafter.
Any other information on results incl. tables
Evolution of body weights in grams:
Animal# |
Sex
|
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
1 |
Male |
2540g |
2675g |
2748g |
2 |
female |
2469g |
2349g |
2577g |
3 |
female |
2360g |
2551g |
2664g |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), with the exception of the irreversible pale red staining which persisted in all animals up to termination of the test, SCARLET RN 1165 is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test article was investigated by topical application of 0.5 g onto 6 cm2 intact dorsal skin of each of three young adult New Zealand rabbits. The scoring of skin reactions was performed l, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the fol lowing reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. Under the conditions of this experiment, SCARLET RN 1165 was found to cause a primary irritation score of 0.00 (max. 8.0) when applied to healthy intact rabbit skin.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
The test article caused irreversible pale red staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any 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.