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EC number: 220-701-7 | CAS number: 2871-01-4
- 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:
- key study
- Study period:
- From 6 June 1983 to August 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No GLP, comparable to OECD Guideline 405 method. No information about the test item was provided (batch, purity, solubility)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No GLP, comparable to OECD Guideline 405 method. No information about the test item was provided (batch, purity, solubility)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-(4-amino-2-nitroanilino)ethanol
- EC Number:
- 220-701-7
- EC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Cas Number:
- 2871-01-4
- Molecular formula:
- C8H11N3O3
- IUPAC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Test material form:
- solid: particulate/powder
- Remarks:
- crystalline powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: porvided by the company company Hans Schwarzkopf GmbH
- Expiration date of the lot/batch: not specified
- Purity test date:not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the test, the test powder was suspended 25 % in 0.5 % carboxymethylcellulose (CMC).
Test animals
- Species:
- rat
- Strain:
- other: BOR: WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Winklemann
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males : 160.0 – 199.8 g / females : 140.0 – 174.0 g
- Fasting period before study: not specified
- Housing: Makrolon Type III, maximum of 5 rats were housed together
- Diet (e.g. ad libitum): Ssniff-R (Complete diet for rats) ad libitum
- Water (e.g. ad libitum): tap water by Makrolon drinking bottles, ad libitum
- Acclimation period: about 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ºC ± 2 ºC
- Humidity (%): 50 - 85 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h/12 hours light daily, from 7.00 to 19.00
IN-LIFE DATES: From: 16 June 1983 To: 7 July 1983
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
MAXIMUM DOSE VOLUME APPLIED: no constant volume applied 0.56 to 3.8 mL
DOSAGE PREPARATION (if unusual): For the test, the test powder was suspended 25 % in 0.5 % carboxymethylcellulose (CMC). - Doses:
- 1000, 2500, 3500 mg/kg
- No. of animals per sex per dose:
- Five animals per dose per sex were used
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The assessment of the clinical-toxicological symptoms was carried out individually and was focused on the course of symptoms. e.g. if the effect was constant over a considerable time, this was noted in the appropriate records.
Another assessment is only made if the symptoms change.
Assessment was made at the following times: 30', 1 + 2 h, 3 + 6 h, 24 h, 48 h,
72 h, 7 and 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weight - Statistics:
- Calculation of the oral LD50 was carried out in that case using the probit analysis after D. Y. Finney: Probit Analysis, 3rd Edition, Cambridge 1971
Results and discussion
- Preliminary study:
- This preliminary test showed (two females rats were exposed at the dose of 1.0, 2.5, 3.5, 5 g/kg) that both animals used with 5 g/kg perished within 24 hours p.a.. One animal died within 24 h p.a. at 2.5 g/kg. At 1.0 g/kg no mortality was found.
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 940 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 950 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose of 5 g/kg bw, 9 of 10 rats died within 24h. At the dose of 3.5 g/kg bw, 4 of 10 rats died within 24h and a total of 6 after 48h. 1 of 10 rats died within 24h at the dose of 2.5 g/kg bw. No mortalities were observed at 1g/kg
- Clinical signs:
- other: At the tested dosages, the preparation increasingly caused reduced activity with apathy, partly significant anomalies in posture and positioning, predominantly significant disturbance to coordination, partly slight to significantly reduced tone in digits
- Gross pathology:
- In the mortalities, red-blue discolouration and sometimes accumulations of liquid in the whole gastro-intestinal tract were found. In the dissection of all surviving animals at the end of the 14-day post-observation period, no macroscopically visible organ changes were found in the cranial, chest or abdominal cavities.
Any other information on results incl. tables
Table1 :Summary of the results – Body weights
Group |
Dose |
original weight |
Number of animals |
final weight |
Number of remaining animals |
I |
1.0 g/kg |
159.35 |
10 |
181.70 |
10 |
II |
2.5 g/kg |
164.43 |
10 |
187.44 |
9 |
III |
3.5 g/kg |
166.69 |
10 |
204.00 |
4 |
IV |
5.0 g/kg |
168.84 |
10 |
212.00 |
1 |
Table2 :Summary of the results – Mortality
24 h |
LD50 |
3/14 days |
LD50 |
Males |
4.20 g/kg |
Males |
3.94 g/kg |
Females |
3.15 g/kg |
Females |
2.95 g/kg |
Males and Females |
3.64 g/kg |
Males and Females |
3.40 g/kg |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the experimental conditions opf this study, the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD40 value was 3400 mg/kg. hence, the test item HC Red 3 was not classififed as Acute Oral Hazard according to CLP regulation, and was classified Category 5 according to GHS criterias.
- Executive summary:
The aim of this no-GLP compliant study investigation was to determine the toxic effect of “H.C. Red 3” after a single oral application to the rat.
Male and females Wistar rats of the BOR: WISW strain, in the weight range 160 to 199g (male) and 140-174 g (female) were administered HC Red n° 3 at the doses of 1, 2.5, 3.5 and 5 g/kg bw by oral intubation (5 males and 5 females per dose). During the observation period of 14 days, a record was kept for mortalities and signs of toxicity. Body weights were recorded on day 0 and day 14 for the surviving animals. All rats that died were investigated macroscopically to identify organ changes in the skull, thorax and abdomen and surviving animals were similarly examined at the end of the 14-day post-observation.
At the dose of 5 g/kg bw, 9 of 10 rats died within 24h. At the dose of 3.5 g/kg bw, 4 of 10 rats died within 24h and a total of 6 after 48h. 1 of 10 rats died within 24h at the dose of 2.5 g/kg bw. No mortalities were observed at 1g/kg. Red-blue colorations of mucosae and urine were observed in all rats. At the tested doses, reduced activity was observed during the first 30 minutes and continued in the surviving
rats up to 72h. After that and during the rest of the observation period, these animals had normal appearance.
Under the experimental conditions opf this study, the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD50 value was 3400 mg/kg. Hence, the test item HC Red 3 was not classififed as Acute Oral Hazard according to CLP regulation and was classified Category 5 according to GHS criterias.
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