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EC number: 259-583-7 | CAS number: 55302-96-0
- 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 31 March 2004 to 21 December 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 17th December 2001
- Deviations:
- yes
- Remarks:
- animal room relative humidity was sometimes outside the target ranges (minor deviation not compromising the validity or integrity of the study)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 5-[(2-hydroxyethyl)amino]-o-cresol
- EC Number:
- 259-583-7
- EC Name:
- 5-[(2-hydroxyethyl)amino]-o-cresol
- Cas Number:
- 55302-96-0
- Molecular formula:
- C9H13NO2
- IUPAC Name:
- 5-[(2-hydroxyethyl)amino]-2-methylphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Analytical purity: 99.3% (HPLC; Area % without response factor, UV detection)
- Purity test date: August 2004
- Lot/batch No.: 0121442
- Expiration date of the lot/batch: September 2005
- Titre: 99.8% (based upon alkalinity in g/100g)
- Description: beige powder
- Trade name: IMEXINE OAG
- Labeling code: 2948
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +4°C, protected from light and under nitrogen gas
- Stability under test conditions: test item dosage forms were prepared extemporaneously under nitrogen atmosphere and stored at room temperature, protected from light (using an aluminium foil) and under nitrogen atmosphere until treatment, for a maximum period of 4 hours according to the stability results obtained.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Rj: SD (IOPS Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8 weeks old on the say of treatment
- Weight at study initiation (mean ± standard deviation): 206 ± 6 g
- Fasting period before study: overnight period of approximately 18 hours before dosing with free access to water. Food was given back approximately 4 hours after administration of the test item.
- Housing: animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and one or four rats of the same group during the treatment period. Each cage contained autoclaved sawdust (SICSA, Alfortville, France). Sawdust was analysed by the supplier for composition and contaminant levels.
- Diet: ad libitum to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), except during the fasting period. Each batch of food was analysed by the supplier for composition and contaminant levels (formula detailed in the study report).
- Water: ad libitum to drinking water filtered by a FG Millipore membrane (0.22 micron). Bacteriological and chemical analyses of water were performed regularly by external laboratories, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines).
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12 cycles of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular intervals.
IN-LIFE DATES: From: March 2004 To: 28 April 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- as 0.5% suspension in purified water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw. The volume administered to each animal was adjusted according to body weight determined on the day of treatment.
DOSAGE PREPARATION (if unusual): Before preparation, the vehicle was degassed by sonication for at least 15 minutes and then saturated with nitrogen gas, and kept under nitrogen atmosphere for 15 minutes. The test item was first ground using a mortar and pestle, then prepared at the chosen concentration in the vehicle. The test item dosage forms were prepared extemporaneously under nitrogen atmosphere and were stored protected from light (using a glass beaker covered with aluminium foil) and under nitrogen atmosphere until delivery. They were used within the 4 hours following the preparation according to the known stability results. The pH of the dosage form at the concentration of 200 mg/mL, measured at the testing laboratory, was approximately 6. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females (one female for the sighting test and one group of four females for the main experiment)
- Control animals:
- no
- Details on study design:
- - Sighting test: test item was administered at the dose of 2000 mg/kg. This dose was chosen according to information available on the test item. One female was used for this sighting test.
- Main experiment: As no mortality was observed at 2000 mg/kg in the sighting test, the test item was administered at the dose-level of 2000 mg/kg to one group of four females.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day. Type, time of onset and duration of clinical signs were recorded for each animal individually. Animals were weighed individually just before the administration of the test item and then 7 days and 14 days following the administration. The body weight gain of the treated animals was compared to that of testing laboratory control animals with a similar initial body weight.
- Sacrifice: At the end of the observation period, all animals were killed by carbon dioxide asphyxiation.
- Necropsy of survivors performed: yes; macroscopic examination as soon as possible after death. A macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. No organ samples were taken for preservation of tissues. - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- - No mortality occurred at 2000 mg/kg.
- Hypoactivity or sedation and piloerection were observed on day 1 within the 2h45 following the treatment.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No death occurred.
- Clinical signs:
- other: Hypoactivity or sedation, piloerection and dyspnea were observed in all animals on day 1 within the 2 hours following the treatment. No clinical signs were observed thereafter on day 1 but from day 2 up to day 5 and then on days 14 and 15, noisy breathing
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the maximum non-lethal dose of the test item 2-methyl-5-hydroxyethylamino-phenol is > 2000 mg/kg bw. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the acute oral toxicity of 2-Methyl-5-hydroxyethylaminophenol, according to fixed dose OECD Guideline 420 method (dated 17th December 2001).
Material and methods
The test material -diluted in 0.5 % carboxymethylcellulose- was administered by oral route (gavage) to a group of 5 female Sprague Dawley rats (one for the sighting test) at a single dose of 2000 mg/kg body weight. A preliminary test (sighting test) preceded the definitive test. Animals were observed for mortality, clinical signs and body weight for 2 weeks and were then subjected to necropsy.
Results
No death occurred during the study.
Hypoactivity or sedation and piloerection were observed on day 1 within the 2h45 following the treatment of the animal of the sighting test. Hypoactivity or sedation, piloerection and dyspnea were observed in all animals of the main test on day 1 within the 2 hours following the treatment. No other clinical signs were observed on day 1 but from day 2 up to day 5 and then on days 14 and 15, noisy breathing was observed in 1/4 animals. This clinical sign was associated with piloerection and swollen abdomen on days 14 and 15.
A body weight loss was seen in 1/4 females between days 1 and 15. The overall body weight gain of the other animals was similar to that of the testing laboratory historical control animals.
At necropsy, no apparent abnormalities were observed.
Conclusion
Under the experimental conditions of this study, the maximal non-lethal dose of the test item 2-methyl-5-hydroxyethylamino-phenol is > 2000 mg/kg. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria.
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