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Diss Factsheets
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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
Eye irritation :
According to the results of the key studies (one in vivo eye irritation study, two in vitro eye irritation studies), the registered substance 4-amino-m-Cresol did not induce irritation of corrosion of mucus membrane or eye after contact. Hence, it can be defined as Not classififed/Not irritating according to CLP regulation.
Skin irritation:
According to the results of the key studies (GLP compliant, Klimisch 1, OECD guideline method 439 and 431), the registered subtance 4 -amino-m-cresol did not induce skin irritation or corrosion on reconstructed human epidermis and was Not classiffied for Irritation and Corrosion.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
To assess the potential eye irritation or corrosion properties of the registered substance 4-amino-m-cresol, three key studies were available :
- One in vivo study (GLP-compliant, followed OECD 405 method, Klimisch 1) was performed. Female Pirbright White guinea pigs were used in the study. 0.1 ml of a 1.5 % dilution of 4-Amino-m-cresol in 50 % propylene glycol was applied into the conjunctival sac of the left eye of 5 female guinea pigs; the right eye served as control. The eyes were not rinsed and were evaluated and scored according to the Draize scoring system 0.5, 1, 2, 3, 4, 6, and 7 h after application. Further readings by means of fluorescein-instillation took place 24 h and 48 h after substance application. No ocular irritant effects were noted at any observation time point after 4-Amino-m-cresol as a 1.5 % dilution in 50 % propylene glycol was instilled into the eyes of guinea pigs without rinsing in 4 of the 5 tested animals. Conjunctival erythema was seen in one animal without any other macroscopic effect. 4-Amino-m-cresol at 1.5 % may have minimal ocular irritant potential.
- Two in vitro studies as Isolated Chicken Eye were performed, the two tests were GLP-compliant, followed OECD 438 method. The first is a Klimisch 2 due to absence of positive control in the test, the test item was used diluted at 1.5% in PEG. The second ICE test was quoted as Klimisch 1 and used pure test item. The most relevant of this two studies is the second according to REACh requirements :
4-Amino-M-Cresol (A074) was evaluated neat. A Skin irritation test using EpiSkinTM Reconstructed Human Epidermis model was performed (GLP compliant, OECD 439 method, Klimisch 1). Triplicate tissues were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The relative mean viability of the test item treated tissues was 63.3% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.
On in vitro studies was available to assess the potential skin corrosion of the test item :
- A Skin Corrosion potential test using EpiSkinTM Reconstructed Human Epidermis model was performed (GLP compliant, OECD 431 method, Klimisch 1). Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. The optical density (OD) was measured at 562 nm. Under experimental conditions of the study, the registered substance did not induce decrease of the viability, 90.1% of viability after 3 minutes exposure and 80.8% of viability after 60 minutes exposure.
Justification for classification or non-classification
Eye irritation :
According to the results of the key studies (one in vivo eye irritation study, two in vitro eye irritation studies), the registered substance 4-amino-m-Cresol did not induce irritation of corrosion of mucus membrane or eye after contact. Hence, it can be defined as Not classififed/Not irritating according to CLP regulation. Non of the study with diluted substance showed irritation potential of the registered substance. Furthermore, the second in vitro key study showed no irritancy too with pure substance.
Skin Irritation/Corrsion
According to the results of the key studies (GLP compliant, Klimisch 1, OECD guideline method 439 and 431), the registered subtance 4 -amino-m-cresol did not induce skin irritation or corrosion on reconstructed human epidermis and was Not classiffied for Irritation and Corrosion.
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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