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Diss Factsheets
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EC number: 220-618-6 | CAS number: 2835-95-2
- 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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data provided, followed scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Code of Federal Regulations 16 CFR 1500.41 (Method of testing primary irritant substances)
- Deviations:
- yes
- Remarks:
- only three rabbits were used against six as recommended by guideline
- GLP compliance:
- no
- Remarks:
- Pre-GLP
Test material
- Reference substance name:
- 5-amino-o-cresol
- EC Number:
- 220-618-6
- EC Name:
- 5-amino-o-cresol
- Cas Number:
- 2835-95-2
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 5-amino-2-methylphenol
- Reference substance name:
- 4-amino-2-hydroxytoluene
- IUPAC Name:
- 4-amino-2-hydroxytoluene
- Test material form:
- not specified
- Details on test material:
- - Name of test material: 4-amino-2-hydroxytoluene
- No other information on ‘details of test material’ was provided in the study report.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- - No information on the details on ‘test animals and environmental conditions’ were provided in the study report.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.5% aqueous gum tragacanth containing 0.05 % sodium sulphite (pH: 7.0)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 2.5% w/v solution
VEHICLE
- Concentration: 0.5% aqueous gum tragacanth containing 0.05 % sodium sulphite (pH: 7.0)
- Lot/batch no.: Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 24 hour
- Observation period:
- 24 and 72 hours post exposure period
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was applied on the intact and abraded skin on back of animal, clipped free of hair (shaved).
- Method of treatment: 0.5 mL of dosing solution was applied under square patch, measuring 1 inch by 1 inch. The animals ware immobilized with patches secured in place by adhesive tape.
USE OF RESTRAINERS FOR PREVENTING INGESTION: Yes; During exposure period, the entire trunk of the animal was then wrapped with an impervious material for the 24-hour period of exposure.
REMOVAL OF TEST SUBSTANCE
- Washing : Yes
- Time after start of exposure: 24 hour
SCORING SYSTEM: The skin reaction were graded on the basis of following scale:
- Erythema and eschar reaction
No erythema:.....................................................................................................................................................0
Very slight erythema (barely perceptible): ...................................................................................................1
Well-defined erythema: ...................................................................................................................................2
Moderate to severe erythema: ........................................................................................................................3
Severe erythema (beet redness) to slight eschar formation (injuries in depth):.................................... 4
- Oedema Formation
No oedema: ........................................................................................................................................................0
Very slight oedema (barely perceptible): .......................................................................................................1
Slight oedema (edges of area well-defined by definite raising): ................................................................2
Moderate oedema (raised approximately 1 mm): .........................................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): .............................4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: erythema and edema score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: 24 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No skin reaction was observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the 72 hour observation period.
- Other effects:
- Not reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under 24 hour occlusive contact, a 2.5% aqueous solution of 4-amino-2-hydroxy toluene showed no skin irritating potential in rabbits under the described test conditions.
Although the test procedure did not follow currently accepted guidelines and the purity of the test substance is unknown, the results can be accepted as being indicative of the irritant potential of a 2.5% dilution of the test substance - Executive summary:
The acute skin irritation potential o f4-amino-2-hydroxy toluene was determined following method according to the Code of Federal Regulations 16 CFR 1500.41 (Method of testing primary irritant substances).
0.5 mL of a 2.5% solution of 4-amino-2-hydroxy toluene in aqueous gum tragacanth (0.5%) containing 0.05% sodium sulphite was applied to shaved areas (about 6.45 cm2) of the back of 3 albino rabbits. After 24 hours under occlusive conditions, the test substance was removed. Animals were examined for signs of erythema and oedema 24 and 72 hours post exposure period.
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
Under 24 hour occlusive contact, a 2.5% aqueous solution of 4-amino-2-hydroxy toluene showed no skin irritating potential in rabbits under the described test conditions. Although the test procedure did not follow currently accepted guidelines and the purity of the test substance is unknown, the results can be accepted as being indicative of the irritant potential of a 2.5% dilution of the test substance.
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