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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 March 1991 to 21 June 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- 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%
- Lot/batch No.: OP 169/2
- Description: brown fine powder
- Trade name: IMEXINE OAG
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV specialized breeding establishment (Les Hautes Noës, Saint mars d'Egrenne, 61350 PASSAIS LA CONCEPTION, FRANCE) .
- Age at study initiation: no data
- Weight at study initiation: between 1 .5 kg and 2 .5 kg
- Housing: Animals were kept in cages of standard size . Excreta were eliminated by unrolling plastified brown paper which was placed under the cages .
- Diet: ad libitum to UAR 112 foodstuff (analytical certificate is provided in the study report).
- Water (e.g. ad libitum): ad libitum to softened tap drinking water in polycarbonate feeder bottles with a stainless steel teat . A water sample was taken every three month and sent to the Department of Veterinary Services, 216, rue Louis Mallet, 18014 BOURGES Cedex, FRANCE for analysis (analytical certificate is provided in the study report).
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 45-65
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 21 March 1991 To: 31 March 1991
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- application site moistened with 0 .5 ml of paraffin oil in order to ensure a good contact between the skin and the test item
- Controls:
- other: The non-treated flank of each animal served as a control
- Amount / concentration applied:
- 0 .5 g of the test item was applied to the right flank of each animal. The non-treated flank of each animal served as a control.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Approximately 1 hour, then 24, 48 and 72 hours after removal of the dressing and of the test item. Observation could be continued until Day 8 and Day 15 if signs of irritation persisted at 72 hours.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Preparation: 24 hours before administration, the dorsal region of each animal was carrefully shaved over two symmetrical zones, measuring at least 14 cm x 5 cm, in relation to the vertebral axis, using an AESCULAP FAVORITA II GT 104 electric trimmer. Any animal with damaged skin was eliminated from the study at the time of application. The left flank of each of the animals was left intact.
- Area of exposure: approximately 6 cm2
- Application: the test item was applied to the right flank of each of the animals. The test item was deposited on a gauze square of approximately 6 cm2 . The side of the gauze in contact with the compound was applied to the skin. The application site was moistened with 0 .5 ml of paraffin oil to ensure a good contact between the skin and the test item. The non-treated flank of each animal served as a control.
- Type of wrap if used: The gauze square was protected by a swab held in place with a URGOPORE microporous and non-allergic non-occlusive dressing, and the whole being held in place by coalescent elastic and cohesive hypoallergenic tape COHEVET . Dressings were held in place for 4 hours after application .
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour, 24, 48 and 72 hours after the end of the exposure period, extended to days 8 and 15 if signs of irritation persisted at 72hours.
SCORING SYSTEM:
Erythema and Scab Formation
No erythema ...................................................................................................................................0
Slight erythema (scarcely perceptible) ...........................................................................................1
Clearly visible erythema ..................................................................................................................2
Moderate to marked erythema ........................................................................................................3
Severe erythema (reddish purple) with formation of slight eschares (deep lesions) ...................4
Oedema Formation
No oedema ..............................................................................................................................0
Very slight oedema (scarcely perceptible)..............................................................................1
Slight oedema (contours well defined, visible swelling) .........................................................2
Moderate oedema (thickness approximateiy 1 mm) ................................................................3
Severe oedema (thickness more than 1 mm and area greater than that of application) .........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The cutaneous application of the test item did not cause any cutaneous irritation reaction in all animals of the study.
The mean indices per rabbit, for the three times together were:
Erythema and edema : 0 in all animals. - Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test material is not classified as irritating to the skin 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 potential of the test material to induce skin irritation in vivo, according to OECD Guideline 404 (dated May 12, 1981).
Material and methods
0.5 g of the solid test material were applied under semi-occlusive dressing during 4 hours, on a shaved skin area (right flank) of 3 female rabbits. The left flank served as a control. Skin reactions were recorded 1 hour and then 24, 48 and 72 hours after the removal of the dressing.
Results
No dermal lesions were observed in any animal at any of the observation time points. The individual mean scores (24, 48 and 72 hours) of all three animals for erythema and edema were both: 0.0, 0.0 and 0.0.
Conclusion
Under the experimental conditions of this study, the test material is not classified as irritating to the skin 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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