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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
Endpoint summary
Administrative data
Description of key information
Eye irritation
According to the result of the key studies (Klimisch 1, GLP compliant, OECD guidelines 438 and 492 methods), the registered substance was defined as No Classififed for Eye Irritation/Corrosion 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-2 -hydroxytoluene 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
Two available key studies were performed in order to assess the eye irritation potential of the registered substance.
- An Isolated Chicken Eye Test (ICE) was performed following OECD GLP principle, OECD guideline 438 method and was quoted as Klimisch 1 :
4 -amino-2 -hydroxytoluene was evaluated neat for eye irritation potential in the Isolated Chicken Eye (ICE) test. In addition, the test included a negative control (saline) and a positive control (BAC). Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of 30 mg for 10 seconds followed by a 20 mL saline rinse. 4 -amino-2-Hydroxytoluene did not cause corneal effects other than very slight corneal swelling (mean swelling 1%). Microscopic examination of the corneas did not reveal any abnormalities.
-A Human Cornea Model Test was performed following OECD 492 method and GLP principle and was quoted as Klimisch 1 :
Each 50 mg of the test item, were applied to each of duplicate EpiOcularTM tissues for 6 hours. Each 50 µL of the negative control (deionised water) and of the positive control (methyl acetate) were also applied to duplicate tissues each. Viability quantification was performed on cells using MTT reduction to formazan approach after 6 hours exposure period and 18 hours post exposure period. Irritating effects were not observed following incubation with 4-Amino-2-Hydroxytoluene (A027). Compared with the negative control the corrected relative mean absorption value corresponding to the viability of the tissues did not decrease below 60% (71.5%).4-amino-2 -hydroxytoluene (A027) was not classified as irritating for eye according CLP regulation.
One in vitro studies was available to assess the potential 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, 100.9% of viability after 3 minutes exposure and 98.4.8% of viability after 60 minutes exposure.
Justification for classification or non-classification
Eye irritation
According the results of the key studies (Klimisch 1, GLP compliant, OECD guideline 438 method and 492 method), the registered substance was defined as No Classififed for Eye Irritation/Corrosion Potential 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-2 -hydroxytoluene did not induce skin irritation or corrosion on reconstructed human epidermis and was Not classiffied for Irritation and Corrosion according CLP criteria.
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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