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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 25 October 2007 to 04 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24th February 1987
- Deviations:
- yes
- Remarks:
- Relative humidity sometimes outside of the target ranges. This minor deviation was not considered to have compromised the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31st July 1992
- Deviations:
- yes
- Remarks:
- Relative humidity sometimes outside of the target ranges. This minor deviation was not considered to have compromised the validity or integrity of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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: 99.8%
- Purity test date: 15 October 2007
- Lot/batch No.: 0135289
- Expiration date of the lot/batch: February 2008
- Description: very light beige to beige fine powder
- Trade name: IMEXINE OAG
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +4°C, protected from light and from humidity and under inert gas.
- Stability under test conditions: Fresh test item dosage forms were prepared extemporaneously under inert atmosphere on the morning of the administration and were kept under inert gas. Test item dosage forms were used within 30 minutes after preparation.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Rj: SD (IOPS Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Weight at study initiation (mean ± standard deviation): 308 ± 9 g for the males and 208 ± 5 g for the females
- Fasting period before study:
- 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 animal during the treatment period. Each cage contained autoclaved sawdust (SICSA, Alfortville, France). Sawdust was analyzed by the supplier for composition and contaminant levels.
- Diet: ad libitum to SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany). Each batch of food is analyzed by the supplier for composition and contaminant levels (diet formula provided 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 are 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 beginning of November 2007: To: 27 November 2007
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- purified water was used to moisten the test item
- Details on dermal exposure:
- TEST SITE
- Preparation of the animals: On the day before treatment, the dorsal area of each animal was clipped (i.e. approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females) using an electric clipper. Only animals with healthy intact skin were used for the study
- Area of exposure: 10% of the total body surface of the animals, calculated according to Meeh's formula (i.e. approximately 5 cm x 7 cm for the males and 5 cm x 6 cm for the females)
- % coverage: 10% of the total body surface of the animals
- Type of wrap if used: The test item and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test item by the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): On removal of the dressing, any residual test item was removed using a dry cotton pad.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A single dose of 2000 mg/kg of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin representing approximately 10% of the total body surface of the animals. The dose applied to each animal was adjusted according to the body weight determined on the day of treatment.
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- one group of 10 animals (5 males and 5 females)
- Control animals:
- no
- Details on study design:
- - 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 (45 mn, 2h -4h), for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15. Type, time of onset and duration of clinical signs were recorded for each animal individually. From day 2, any local cutaneous reaction was recorded.
Animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of testing laboratory control animals with a similar initial body weight.
- Sacrifice: On day 15, all animals were sacrificed by carbon dioxide asphyxiation.
- Necropsy of survivors performed: yes; macroscopic examination as soon as possible after death. 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:
- Not applicable.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality, no clinical signs and no macroscopic findings
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed during the study. An orange coloration of the skin was observed in all animals from day 2 until day 6 (1/5 males), day 10 (another male) or day 15 (3/5 males and 5/5 females). An erythema was noted in 2/10 animals on day 2;
- 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 dermal LD50 of the test item is > 2000 mg/kg body weight without mortality, clinical signs or macroscopic findings. Thus, the test item is not classified as hazardous for acute dermal toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the acute dermal toxicity of 2-Methyl-5-hydroxyethylaminophenol, according to OECD 402 (dated 24th February 1987) and EC 92/69/EEC, B.3 (dated 31st July 1992) guidelines.
Material and methods
The test item was applied in its original form at the dose-level of 2000 mg/kg to the skin of one group of 10 Sprague-Dawley rats (5 males and 5 females). The test site was then covered by a semi-occlusive dressing for 24 hours.
The animals were observed for clinical signs, mortality and body weight gain for a period of 14 days following the single application of the test item. All animals were subjected to necropsy.
Results
No deaths and no clinical signs were observed during the study.
An orange coloration of the skin was observed in all animals from day 2 until day 6 (1/5 males), day 10 (another male) or day 15 (3/5 males and 5/5 females). An erythema was noted in 2/10 animals on day 2; it persisted in one of them until day 6. A dryness of the skin was noted in 1/10 animals from day 3 until day 6. Crusts were observed in 3/10 animals from day 7 until day 10 (2/3 animals) or day 15 (1/3 animals).
When compared to the testing laboratory historical control animals, a slightly lower body weight gain was noted in 1/5 males and 1/5 females between day 1 and day 8; it returned to normal thereafter. The body weight gain of the other animals was not affected by treatment with the test item.
No apparent abnormalities were observed at necropsy in any animal.
Conclusion
Under the experimental conditions of this study, the dermal LD50 of the test item is > 2000 mg/kg body weight without mortality, clinical signs or macroscopic findings. Thus, the test item is not classified as hazardous for acute dermal toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
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