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Diss Factsheets
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EC number: - | 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
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 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Molecular formula:
- C26H20.85Br1.82Na1.97N3O9S2
- IUPAC Name:
- Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 79579176, DCT # 80226
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 8 to 11 weeks
- Housing: The rabbits were individually housed in elevated wire mesh cages in temperature controlled rooms reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): water from bottles were available ad libitum
- Acclimation period: The rabbits were equilibrated for at least 7 days.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- 24 hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. The rabbits were returned to their cages overnight. Just prior to dosing, the backs of even-numbered rabbits were abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding.
Following removal of the binder at 24 hours, the test site was washed with warm tap water. One hour after washing, the test site were graded for skin irritation .
Evaluation of skin reactions:
Erythema & Eschar Formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Edema Formation:
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 millimeter): 3
- Severe edema (raised more than 1 millimeter and extending beyond the area of exposure): 3 - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 4 rabbits (2 males and 2 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rabbits observed daily and body weight were recorded pretest and at 7 and 14 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight.
Results and discussion
- Preliminary study:
- None
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died at day 1 of the experiment (Animal number 3).
- Clinical signs:
- other: - Few or no feces present in pan: Animal #2, days 9-14. - Lethargy: Animal #2, days 11-14. - Ptosis: Animal #2, day 13. - Yellow nasal discharge: Animal #4, days 5 & 6.
- Gross pathology:
- Necropsy observations:
- Animals 1&4: normal.
- Animal 2: Bloated intestines.
- Animal 3: Brown exudate, anogenital area, yellow areas on intestines, dark & mottled liver, dark areas on lungs, large spleen.
Any other information on results incl. tables
Individual body weight and skin grades:
Rabbit number | Sex | Weights-kg | ||
0 | 7 | 14 | ||
1 | M | 1.9 | 2.3 | 2.4 |
2 ab | M | 2.3 | 2.3 | 2.4 |
3 | F | 2.1 | Died on day 1 | |
4 ab | F | 2.5 | 2.5 | 2.6 |
ab: Abraded
Redness | Edema | ||||
25 h | 7 | 14 | 25 h | 7 | 14 |
0 | 0 | 0 | 0 | 0 | 0 |
1 | 1 | 0 | 0 | 0 | 0 |
2 | 1 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of FAT 40069 in rabbits is greater than 2000 mg/kg bw.
- Executive summary:
An acute dermal toxicity was performed for FAT 40069 in rabbits. The test was performed on New Zealand White rabbits at approximately 8 to 11 weeks of age. Twenty-four hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. Just prior to dosing, the backs of even-numbered rabbits were abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally , scratched the stratum corneum, but did not disturb the derma or produce bleeding. The test material was applied to the backs of 2 male and 2 female rabbits at a dose of 2000 mg/kg bw. The test site was covered with gauze and the trunk was wrapped with impervious material for 24 hours. Following removal of the binder at 24 hours, the test site was washed with warm tap water. One hour after washing, the test site were graded for skin irritation. Skin areas were read again at 7 and 14 days. Bodyweights were recorded pretest and at 7 and 14 days: The rabbits were observed daily for 14 days for signs of toxicity and mortality. Necropsies were performed on all rabbits. Mortality was observed in 1/4 - Animal 3, day 1. Few or no feces present in pan: Animal 2, days 9 -14. In conclusion, the acute dermal LD50 of FAT 40069 in rabbits is greater than 2000 mg/kg bw.
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