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EC number: 700-502-6 | 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2008-03-20 to 2008-04-04
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- rat, Wistar Crl:(WI)BR (outbred, SPF-Quality)
nulliparous and non-pregnant
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % aqueous methylcellulose
- Doses:
- 2000 mg/kg (10 mL/kg) bw (limit dose)
- No. of animals per sex per dose:
- 3 females (nulliparous, non pregnant)/group
(2 treatment groups, single oral administration at limit dose 2000 mg/kg bw tested) - Control animals:
- no
- Details on study design:
- The acute toxic class method according to OECD 423 and Directive 2004/73/EC B.1. tris was performed with F 213 Red in rats. Two groups of 3 female CRL:(WI) BR Wistar rats were treated with F 213 Red by single oral gavage at dose levels of 2000 mg/kg bw (Treatment groups 1 and 2) in 1 % aqueous methylcellulose in two independent experiments. Based on the results of the study and according to the criteria of the relevant test guidelines no further testing was performed. The concentration of the formulations was 200 mg/mL in both steps to ensure the constant treatment volume of 10 mL/kg bw.
- Statistics:
- no data
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- In both treatment groups one female CRL:(WI) BR rat died after single oral administration of F213 Red at 2000 mg/kg bw dose level.
- Clinical signs:
- Treatment group 1 (2000 mg/kg bw): Decreased activity (2/3), squatting position (2/3), swollen abdomen (1/3), piloerection (1/3), dyspnoea (1/3), noisy breathing (1/3) and emaciation (1/3) were observed in the first treatment group. The first clinical signs appeared from 1st and 3rd hours after the treatment and ceased on day 1. After a transient (4 days) recovery, clinical signs appeared again, and significant loss of the body weight was noted for animal found dead on day 14. In the bedding material, reddish coloured urine and stool were observed from the 2nd hour, which disappeared on day 1 and day 4, respectively.
Treatment group 2 (2000 mg/kg bw): Slight activity decrease and squatting position were observed on animal No.: 9883 3 hours after the treatment. One day thereafter, marked activity decrease, squatting position, piloerection and dyspnoea were noted and this animal was found dead on day 2. Two animals of this group were symptom-free during the day of the treatment and following 14-day observation period. In the bedding material, reddish coloured urine and stool were observed from the 2nd hour, which disappeared on day 1 and day 4, respectively. - Body weight:
- Treatment group 1 (2000 mg/kg bw): A significant body weight loss was noted for animal No.: 9844 (died on day 14) on weeks 1 and 2. The body weight development of surviving animals was considered to be normal.
Treatment group 2 (2000 mg/kg bw ): There was no test item influence on the body weight and body weight gain of these animals. - Gross pathology:
- Treatment group 1 (2000 mg/kg bw): In dead animal (No.: 9844), under nourishment, dark red coloured left lobe of lungs, congestive liver and empty, gas filled stomach and intestines were observed. In surviving animals (No.: 9833 and 9856) pale raised areas were found in the lungs.
Treatment group 2 (2000 mg/kg bw): Animal found dead (No.: 9883) showed dark red lungs, congestive liver and reddish content in the stomach and coecum. In surviving animals (No.: 9868 and 9870), pinprick sized haemorrhages were observed in the lungs. In summary, reddish content in the stomach and coecum was indicative of the presence of the test item in the gastro-intestinal tract in dead animal of Treatment group 2. The pulmonary alterations (dark red colour) and congestive liver of dead animals were signs of circulatory disturbance developed during the death. The pale raised areas and haemorrhages in the lungs were due to the method of anaesthesia and exsanguination, which are also observable in untreated animals after anaesthesia. - Other findings:
- not applicable
Any other information on results incl. tables
no remarks
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, a single oral administration of the test item F 213 Red caused death of female CRL:(WI)BR rats at 2000 mg/kg bw (2/6). According to the Globally Harmonised Classification System, the acute oral LD50 value of F 213 Red was greater than 2000 mg/kg body weight in female CRL:(WI) BR rats and it was ranked into Category 5 with a cut off value of 2500 mg/kg bw. According to directive 2001/59/EC, classification of F 213 Red by the oral route is not required based on the results of this study.
- Executive summary:
he acute toxic class method according to OECD 423 and Directive 2004/73/EC B.1. tris was performed with F 213 Red in rats. Two groups of 3 female CRL:(WI) BR Wistar rats were treated with F 213 Red by single oral gavage at dose levels of 2000 mg/kg bw (Treatment groups 1 and 2) in 1 % aqueous methylcellulose in two independent experiments. Based on the results of the study and according to the criteria of the relevant test guidelines no further testing was performed. The concentration of the formulations was 200 mg/mL in both steps to ensure the constant treatment volume of 10 mL/kg bw.
Clinical signs:
Treatment group 1 (2000 mg/kg bw): One animal of the first treatment group was found dead on day 14. Clinical signs observed from 1st and 3rd hour after the treatment (dyspnoea, activity decrease, squatting position and piloerection) ceased on day 1. After a transient (4 days) recovery, decreased activity, squatting position, swollen abdomen, piloerection, dyspnoea, noisy breathing and significant loss of the body weight were found. Gross pathology revealed no test item related macroscopic findings. In one of surviving animals, decreased activity and squatting position were observed between the third and six hours after the treatment. There were no body weight changes and necropsy findings related to treatment with F 213 Red. Reddish coloured urine and stool were observed in the bedding material from 2nd hour, which disappeared on day 1 and day 4, respectively.
Treatment group 2 (2000 mg/kg bw): Decreased activity, squatting position, piloerection and dyspnoea were noted for animal found dead on day 2 of study. Residue of the test item was noted in the stomach and coecum at the necropsy. Remaining two animals of this group were symptom-free during the entire observation period. The body weight development was considered to be normal. No macroscopic findings related to the test item effect were observed. Reddish coloured urine and stool were observed in the bedding material from 2nd hour, which disappeared on day 1 and day 4, respectively.
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