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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Study period:
- August 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Data source
Reference
- Reference Type:
- publication
- Title:
- Hair Dye 4-AMINO-2-HYDROXYTOLUENE Colipa No. A027 Calculation of acute toxicity values using existing in vivo study data
- Author:
- Nicola J. Hewitt
- Year:
- 2 017
- Bibliographic source:
- Colipa No.1027
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The acute Oral LD50 was determined at 3600 mg/kg in rats in a Klimisch 2 study. Using this LD50, extrapolation calculation was performed in order to evaluate a LD50 value for dermal route.
- GLP compliance:
- no
- Test type:
- other: Extrapolation calculation
- Limit test:
- no
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
Constituent 1
- Specific details on test material used for the study:
- No test material was used for this report, the calculation was performed with the LD50 of a oral acute toxicity test with the test subtance for Inhalation LD50 determination.
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 5 688 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Calculation:
Determination of the correction factor oral vs. dermal route:
84% oral vs. 53% dermal = 2.63 (84 / 53 = 1.58)
Determination of the LD50 calc dermal:
3600 mg/kg bw x 1.58 = 5688 mg/kg bw
Result:
LD50 calc dermal 4-AMINO-2-HYDROXYTOLUENE = 5688 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- not classified according to CLP
- Conclusions:
- The calculated acute dermal toxicity of 4-AMINO-2-HYDROXYTOLUENE (LD50, calc, dermal) is 5688 mg/kg bw. The LD50,calc,dermal value indicates that 4-AMINO-2-HYDROXYTOLUENE should be classified as Acute Tox Cat.5; H313: “may be harmful in contact with skin”, according to the Globally Harmonized System of Classification and Labeling (GHS) and not classified according to CLP regulation.
- Executive summary:
This calculation was performed in order to determine the LD50 value in dermal route based on the experimental LD50 oral value (3600 mg/kg bw).
Values and assumptions used in the calculations:
• 4-AMINO-2-HYDROXYTOLUENE LD50 oral = 3600 mg/kg bw in the rat
• Oral Bioavailability = 84% (at 500 mg/kg bw, using the data from the toxicokinetics study in Wistar rats). This value was selected to achieve a more conservative approach (worst case scenario) because incorporation of this value into Equations 7 results in a lower LC50 calc dermal. value (higher assumed toxicity) than if the value of 95% was selected.
• Dermal bioavailability = 53% (at 12.5 mg/kg bw). This value was selected (assuming higher toxicity as a result of a higher bioavailability) because incorporation of this value into equiation results in a lower LD50 calc dermal value (with an assumed higher toxicity). In addition, dermal absorption is dose-dependent, such that higher doses lead to lower absorption; therefore, the high LD50 dose would be expected to have lower absorption than assumed for this calculation.
Calculation:
Determination of the correction factor oral vs. dermal route:
84% oral vs. 53% dermal = 2.63 (84 / 53 = 1.58)
Determination of the LD50 calc dermal:
3600 mg/kg bw x 1.58 = 5688 mg/kg bw
Result:
LD50 calc dermal 4-AMINO-2-HYDROXYTOLUENE = 5688 mg/kg bw
The calculated acute dermal toxicity of 4-AMINO-2-HYDROXYTOLUENE (LD50, calc, dermal) is 5688 mg/kg bw. The LD50,calc,dermal value indicates that 4-AMINO-2-HYDROXYTOLUENE should be classified as Acute Tox Cat.5; H313: “may be harmful in contact with skin”, according to the Globally Harmonized System of Classification and Labeling (GHS).
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