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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-269-2 | CAS number: 25797-81-3
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- FAT 20033/L TE
- IUPAC Name:
- FAT 20033/L TE
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 247-269-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 25797-81-3
- Molecular formula:
- C24H23N3O8S2.Na
- IUPAC Name:
- sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- powder / dark blue
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E0T425-11 (OCT No. 70083)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, Pennsylvania
- Weight at study initiation: 1.6 - 2.4 kg
- Housing: in accordance with standard laboratory procedures
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back side
- % coverage: 30%
- Type of wrap if used: elastic sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3g/kg
- Duration of exposure:
- 24 h
- Doses:
- 3 g/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Twenty-four hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper, exposing approximately 30 % of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. The animals were then returned to their individual cages and observed for toxic signs and survival.
OBSERVATIONS:
The animals were observed daily for adverse reaction and survival for a period of 14 days. In addition, local skin reactions were evaluated at 1, 7 and 14 days. Body weights were recorded prior to dosing and at days 7 and 14. Gross necropsies are performed on all animals. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen throughout the observation period.
- Gross pathology:
- All gross necropsies were within normal limits.
- Other findings:
- Edema and erythema were present on all sites for 72 hours and on five sites for four days. The remaining site, at this time, displayed erythema. On the fifth day of scoring, four animals demonstrated erythema and two demonstrated both edema and erythema. On days six, seven and eight, irritation grading showed three animals displaying erythema. After this time, all animals returned to normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of FAT 20033/D in New Zealand albino rabbits is >3 g/kg bw.
- Executive summary:
A study was conducted to assess the acute dermal toxicity of FAT 20033/D in New Zealand albino rabbits. A group of 6 animals (3/sex/dose) were used for the study. Twenty-four hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper, exposing approximately 30% of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. No mortalities were observed throughout the study. Oedema and erythema were present on all sites for 72 hours and on five sites for four days. The remaining site, at this time, displayed erythema. On the fifth day of scoring, four animals demonstrated erythema and two demonstrated both edema and erythema. On days six, seven and eight, irritation grading showed three animals displaying erythema. After this time, all animals returned to normal. All gross necropsies were within normal limits. Based on the study results, the dermal LD50 of the test substance was found to be >3,000 mg/kg bw in NZ albino rabbits.
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.