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EC number: 225-555-8 | CAS number: 4926-55-0
- 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 5 January 1987 to 8 January 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No detail on the test item was provided ( purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given. The non GLP-compliant study did not follow modern standard but give information on the range of the LD50 value.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No detail on the test item was provided ( purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-[(2-nitrophenyl)amino]ethanol
- EC Number:
- 225-555-8
- EC Name:
- 2-[(2-nitrophenyl)amino]ethanol
- Cas Number:
- 4926-55-0
- Molecular formula:
- C8H10N2O3
- IUPAC Name:
- 2-[(2-nitrophenyl)amino]ethanol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Batch No. 4250786
No details of the test item was provided in the study.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
No details of the test item was provided in the study.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was used at 10% in suspension in 3% acacia.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Clairol stock colony
- Females (if applicable) nulliparous and non-pregnant: Not specified in the study
- Age at study initiation: not specified
- Weight at study initiation: 180 to 300 mg (males and females)
- Fasting period before study: Animals were fasted for a 24 hours period prior dosing
- Housing: not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: for at least 7 days
ENVIRONMENTAL CONDITIONS
Environmental and housing conditions were not reported in the study report
IN-LIFE DATES: From 12 December 1986 To 8 January 1987
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 3% acacia
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% of test item in 3% acacia
- Amount of vehicle (if gavage): not reported
- Justification for choice of vehicle: no justification provided
- Lot/batch no. (if required): not specified
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: Not specified
DOSAGE PREPARATION (if unusual): test item in suspension in vehicle
- Doses:
- Three doses were used in this study : 625, 1250 and 2500 mg/kg bw
- No. of animals per sex per dose:
- Five animals per sex per dose were used in the main study,
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days observation period, If signs of extreme toxicity were noted, the observation period may be extended to 14 days.
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
- Other examinations performed: mortality, pharmacologic and toxicologic effects
Results and discussion
- Preliminary study:
- A preliminary study was performed to determined if the estimated Lethal Dose 50 is above 5000 mg/kg bw in rats. More than one animal died and three groups were selected for dosing at different dose level.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 250 - < 2 500 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 625 - < 1 250 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the low dose no mortalities were observed, at the mid dose no deaths were seen in the males while 3 of 5 females died within 8 h after dosing. At the high dose all animals died.
- Clinical signs:
- other: No clinical sign was observed
Any other information on results incl. tables
Table 1 :Summaryof theresults
|
Hours |
|
|
|
Days |
|
|
|
|
|
|
|
Dose |
0-1 |
1-3 |
3-8 |
8-24 |
2 |
3 |
4 |
5 |
6 |
7 |
TOTAL |
|
Male |
625 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
1250 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2500 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Female |
625 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
1250 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3/5 |
|
2500 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- No detail on the test item was provided (purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given. The non GLP-compliant study did not follow modern standard but give information on the range of the LD50 value.
- Conclusions:
- Under the experimental conditions of this study, the test item induced mortality of all animals at the high dose level. However, in male male, no mortaility was found at 1250 mg/kg bw and 3 females were found dead at this dose level. The LD50 value was below the value of 2500 mg/kg bw and for female was between 625 mg/kg bw and 1250 mg/kg bw. Hence, the test item was classified as Acute Oral Hazard Category 4 according CLP criteria.
- Executive summary:
This non-GLP compliant study was performed in order to assess the potential Acute Oral Toxicity of the test item HC Yellow 2 in rats. No detail on the test item was provided (purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given. The non GLP-compliant study did not follow modern standard but give information on the range of the LD50 value in acute oral toxicity test on rats.
A 10% suspension of the test substance in 3% acacia was administered once via oral gavage to groups of 5 male and 5 female rats at the dose levels 625, 1250, and 2500 mg/kg bw. At the low dose no mortalities were observed, at the mid dose no deaths were seen in the males while 3 of 5 females died within 8 h after dosing. At the high dose all animals died.
Under the experimental conditions of this study, the test item induced mortality of all animals at the high dose level. However, in male, no mortaility was found at 1250 mg/kg bw and 3 females were found dead at this dose level. The LD50 value was below the value of 2500 mg/kg bw and for female was between 625 mg/kg bw and 1250 mg/kg bw. Hence, the test item was classified as Acute Oral Hazard Category 4 according to CLP criteria.
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