Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-621-2 | CAS number: 2835-99-6
- 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
- Justification for type of information:
- Based on the available in vivo oral acute study to investigate the oral LD50 , together with a toxicokinetics (ADME) study of topically applied compound, the acute dermal toxicity of 4-AMINO-m-CRESOL could be determined.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- For the dermal end point, the data derived from the ADME study (with respect to the duration of test item and animal number) was in line with the OECD guideline 402 for acute dermal toxicity. The approach to determine dermal toxicity by using oral data is accepted by the German and EU regulatory bodies and is based on the current state-of-the-art science. For the determination of the acute dermal toxicity, the bioavailability after topical application was used, which is lower than the oral bioavailability, as demonstrated by kinetics data.
- GLP compliance:
- no
- Test type:
- other: Extrapolation calculation method
- Limit test:
- no
Test material
- Reference substance name:
- 4-amino-m-cresol
- EC Number:
- 220-621-2
- EC Name:
- 4-amino-m-cresol
- Cas Number:
- 2835-99-6
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 4-amino-m-cresol
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 409 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Determination of the correction factor oral vs. dermal route:
100% oral vs. 36% dermal = 2.8 (105 / 36 = 2.77)
Determination of the LD50 calc dermal:
870 mg/kg bw x 2.7 = 2409 mg/kg bw
Result:
LD50 calc dermal 4-AMINO-m-CRESOL = 2409 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- As demonstrated by in vivo toxicokinetics data, the bioavailability after application to the skin is lower than the oral bioavailability. The calculated dermal toxicity of 4-AMINO-m-CRESOL is 2409 mg/kg bw. The LD50, calc, dermal value indicates that 4-AMINO-m-CRESOL 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).
- Executive summary:
Based on the available in vivo oral acute study to investigate the oral LD50 , together with a toxicokinetics (ADME) study of topically applied compound, the aim of this report was to determine the acute dermal toxicity of 4-AMINO-m-CRESOL.
Values and assumptions used in the calculations:
• 4-AMINO-m-CRESOL LD50 oral = 870 mg/kg bw in the rat
• Oral Bioavailability = 100% (at 60 mg/kg bw, using the data from the toxicokinetics study in Wistar rats).
• Dermal bioavailability = 36% (24 h exposure). This value was selected (assuming higher toxicity as a result of a higher bioavailability) because incorporation of this value into Equation 6 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.
Determination of the correction factor oral vs. dermal route:
100% oral vs. 36% dermal = 2.8 (105 / 36 = 2.77)
Determination of the LD50 calc dermal:
870 mg/kg bw x 2.7 = 2409 mg/kg bw
Result:
LD50 calc dermal 4-AMINO-m-CRESOL = 2409 mg/kg bw
As demonstrated by in vivo toxicokinetics data, the bioavailability after application to the skin is lower than the oral bioavailability. The calculated dermal toxicity of 4-AMINO-m-CRESOL is 2409 mg/kg bw. The LD50, calc, dermal value indicates that 4-AMINO-m-CRESOL 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.