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EC number: 812-549-0 | CAS number: 881539-89-5
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 - 20 Feb 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted in 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service, Bratislava, Slovak Republic
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- disodium 4-[(1-hydroxyprop-2-en-1-yl)amino]-4'-(prop-2-enamido)-[1,1'-biphenyl]-2,2'-disulfonate
- EC Number:
- 812-549-0
- Cas Number:
- 881539-89-5
- Molecular formula:
- C18H14N2Na2O8S2
- IUPAC Name:
- disodium 4-[(1-hydroxyprop-2-en-1-yl)amino]-4'-(prop-2-enamido)-[1,1'-biphenyl]-2,2'-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: VELAZ PRAHA, Czech Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 184 - 211 g (range)
- Fasting period before study: Animals were fasted 10 - 12 hours prior to dosing (food but not water was withheld over night). Following the period of fasting, animals were weighed, and the test item administered. After test item administration, food was withheld for a further 3 - 4 h.
- Housing: Three animals per cage were housed in plastic cages suspended on stainless steel racks. Bedding used: SAFE 3/4 S, JRS J. Rettenmaier & Söhne GmbH + Co KG.
- Diet: The laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was available ad libitum.
- Water: The animals received tap water for human consumption ad libitum. The quality of drinking water is periodically analyzed and recorded.
- Acclimation period: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 - 60
- Air changes: Animal room was equipped with central air conditioning.
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 04 Feb 2020 To: 20 Feb 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- water for injection
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (gavage): 5 mL/kg bw
- Justification for choice of vehicle: An aqueous solution/suspension/emulsion is a common vehicle in toxicity studies like OECD TG 423.
- Lot/batch no.: 18H0902 (Bieffe Medital S. p. A, Italy)
MAXIMUM DOSE VOLUME APPLIED
Administration volume was 5 mL/kg bw.
DOSAGE PREPARATION
The required amount of the test item was mixed with vehicle shortly before administration.
CLASS METHOD
- Rationale for the selection of the starting dose: A limit dose of 2000 mg/kg bw was used as a starting dose because available information indicated that the test item was likely to be non-toxic regarding acute toxicity. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs individually immediately after administration of the test item and 0.5, 1, 2, and 4 h later, and daily thereafter for the next 14 days. Individual body weights of animals were measured immediately prior to administration of the test item and weekly thereafter.
- Necropsy of survivors performed: Yes.
- Examinations performed: All test animals were subjected to gross necropsy. - Statistics:
- Not applicable.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period (see Table 1 under "Any other information on results incl. tables").
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
Any other information on results incl. tables
Table 1. Acute oral toxicity
Dose [mg/kg bw] |
Mortality |
Clinical signs |
|
N* |
N* |
Females |
||
2000 |
0/6 |
0/6 |
*N= Number of animals/ number of animals used
Table 2: Body weight
Sex | Dose | Animal ID | Body weight (g) | Body weight (g) | Body weight (g) | Body weight difference (g) | Body weight difference (g) | Body weight difference (g) |
Initial | Week 1 | Week 2 | Week 1 - Initial | Week 2 - Initial | Week 2 - Week 1 | |||
female | 2000 mg/kg bw | 1 | 211 | 223 | 242 | 12 | 31 | 19 |
female | 2000 mg/kg bw | 2 | 198 | 218 | 234 | 20 | 36 | 16 |
female | 2000 mg/kg bw | 3 | 195 | 204 | 235 | 9 | 40 | 31 |
female | 2000 mg/kg bw | 4 | 185 | 217 | 228 | 32 | 43 | 11 |
female | 2000 mg/kg bw | 5 | 189 | 236 | 256 | 47 | 67 | 20 |
female | 2000 mg/kg bw | 6 | 184 | 209 | 225 | 25 | 41 | 16 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The test substance AF-959 administered once to 6 female Wistar rats at a limit dose of 2000 mg/kg bw did not cause death, signs of toxicity, body weight losses, or macroscopic pathological changes.
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