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EC number: 228-819-0 | CAS number: 6359-98-4
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- Groups of four Sprague-Dawley rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered by gavage. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Acid Yellow 017
- IUPAC Name:
- Acid Yellow 017
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: from 150 to 227 grams.
- Housing: following oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages.
- Fasting period before study: 16 hours period immediately prior to oral intubation.
- Diet: standard laboratory diet, ad libitum.
- Water: ad libitum.
- Acclimation period: all animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
The test material was administered as a 50. 0 percent (w/v) aqueous suspension. - Doses:
- 4600, 6800, 10200, 15400 mg/kg
- No. of animals per sex per dose:
- 2 males and 2 females
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Observations and weighing: initial and final body weights as well as all mortalities and/or reactions displayed were recorded.
- Necropsy of survivors performed: necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days. - Statistics:
- At the end of the observation period, the acute oral median lethal dose (LD50) of each test material was calculated using the techniques of Weil, Thompson, and Thompson and Weil.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Standard Deviation of LD50 = ± 1200 mg/kg
- Mortality:
- No death occurred at 4600 and 6800 mg/kg. At 10200 2 oput of 4 rats died, while at 15400 mg/kg no rat survived.
- Clinical signs:
- other: Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.
- Gross pathology:
- Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.
Any other information on results incl. tables
Mortality and Body Weight Data
Dose (mg/kg) | Animal N. and sex | Individual body weight (g) | Number Dead/Number Tested | Percent Dead |
|
Test day N. | |||||
0 | 14 | ||||
4600 | 1M | 184 | 242 | 0/4 | 0 |
2M | 160 | 244 | |||
3F | 174 | 194 | |||
4F | 172 | 177 | |||
6800 | 5M | 182 | 250 | 0/4 | 0 |
6M | 177 | 250 | |||
7F | 158 | 192 | |||
8F | 158 | 167 | |||
10200 | 9M | 178 | (6-22 hrs) | 2/4 | 50 |
10M | 205 | 268 | |||
11F | 156 | (6-22 hrs) | |||
12F | 150 | 178 | |||
15400 | 13M | 160 | (6-22 hrs) | 4/4 |
100 |
14M |
189 |
(6-22 hrs) |
|||
15F |
163 |
(6-22 hrs) |
|||
16F |
184 |
(6-22 hrs) |
Summary of Reactions
Dose (mg/kg) | Reaction | Time of onset after dose administration | Duration of reaction |
4600 | Hypoactivity | 1 hour | 2 days |
Ruffed fur | 6 - 2 2 hours | 1 day | |
6800 | Hypoactivity | 1 hour | 3 days |
Ruffed fur | 5 hours | 3 days | |
Muscular weakness | 5 hours | 1 day | |
10200 | Hypoactivity | 1 hour | 3 days |
Ruffed fur | 1 hour | 3 days | |
Muscular weakness | 3 hours | 2 days | |
15400 | Hypoactivity | 1 hour | Until death |
Ruffed fur | 1 hour | Until death | |
Muscular weakness | 1 hour | Until death | |
Prostration | 5 hours | Until death |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50: 10200 mg/Kg bw.
- Executive summary:
Method
Young albino rats of the Sprague-Dawley strain were used in order to assess the cute toxicity potential by otral route of the test item. Selected groups of four rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.
Results
No death occurred at 4600 and 6800 mg/kg; at 10200 mg/kg 2 out of 4 rats died, while at 15400 mg/kg no rat survived.
Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.
Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.
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