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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
Endpoint summary
Administrative data
Description of key information
According the result of the key study (Klimisch 1, GLP, OECD guideline 429 method followed), the registered substance 4 -amino-m-cresol induced delayed contact hypersensibility on LLNA Local Lymph Node Assay and EC3 values were calculated for DMSO vehicle, as 1.45% and for aqua/acetone/oil vehicle as 2.15%. According to the CLP regulation and criteria, the registered substance was classified as Category 1A for sensitizing effect.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The key study was performed to assess the skin sensitization potential of 4-amino-m-cresol by following the OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)(GLP compliant study, Klimisch 1). A total of 55 Female CBA/J mice of 10 week age. 25 μL of 0 (vehicle only), 0.5, 1.5, 5 and 10 % of 4-amino-m-cresol in DMSO and 0.5, 1.5, 3 and 5 % in a mixture of aqua/acetone (1:1) with olive oil (3:1) (equal to the maximum solubility) were applied to the surface of the ear to each of five female CBA/J mice per group for three consecutive days.. p-Phenylenediamine (PPD) at 1 % in DMSO was used as the positive control in parallel under identical test conditions. Animals were checked for morbidity/mortality at least once daily. Observation for clinical signs was done daily before and at least once after dosing. Body weight was determined on Day -2 and on Day 5.On Day 5, the mice received an intravenous injection of 250 μL phosphate buffered saline containing 23.6 μCi of [H3] methyl thymidine. Approximately 5 hours later, the mice were and the draining auricular lymph nodes were removed and weighed. After preparing a single cell suspension for each mouse, cells were precipitated by TCA and the radioactivity was determined (incorporation of [H3] methyl thymidine in the pellets) by means of liquid scintillation counting as disintegration per minute (dpm).
Lymph node weights were increased after treatment with 4-amino-m-cresol as compared to the vehicle controls indicating an immune response in both vehicles. The mean stimulation indices were affected in a dose-dependent manner by the treatment with 4-amino-m-cresol. With the test substance in DMSO, mean stimulation indices of 0.9, 3.1, 6.5 and 6.7 were obtained for the 4 test concentrations of 0.5, 1.5, 5 and 10 %, respectively. An EC3 value (equal to the concentration inducing a stimulation index of 3) of 1.45 % was calculated. In the second vehicle (aqua/acetone/olive oil), the indices were 1.5, 1.7, 4.7 and 6.9 for the 4 test concentrations of 0.5, 1.5, 3 and 5 %, respectively. An EC3 value of 2.15 % was calculated from these findings.
4-amino-m-cresol induced a biologically relevant immune response in local lymph nodes after dermal application to the mouse ear with either vehicle (DMSO or aqua/acetone/olive oil ) used. EC3 values of 1.45 % and 2.15 % were calculated for DMSO and aqua/acetone/olive oil, respectively. The concurrent positive control demonstrated the sensitivity of the assay.
Justification for classification or non-classification
According to the result of the key study (Klimisch 1, GLP, OECD guideline 429 method followed), the registered substance 4 -amino-m-cresol induced delayed contact hypersensibility on LLNA Local Lymph Node Assay and EC3 values were calculated for DMSO vehicle, as 1.45% and for aqua/acetone/oil vehicle as 2.15%. According to the CLP regulation and criteria, the registered substance was classified as Category 1A for sensitizing effect.
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.
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