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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
Immunotoxicity
Administrative data
Description of key information
According the results of the key studies (Klimisch 2), the registered substance 4-amino-2-hydroxytoluene can inhibit the mixed lymphocyte reaction. Hence, the No observe Adverse Effect was defined as below 10 µg/mL for lymphocyte culture (in vitro method) and above 120 mg/kg bw/day on rabbit for the immunosuppresive property (high dose level used in the study) .
Key value for chemical safety assessment
Effect on immunotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 120 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
Additional information
In thein vivostudy, the capacity of the test substance 5-amino-o-cresol to suppress humoral immunological responses was investigated by studying their ability to: inhibit the production of circulating antibodies to sheep red blood cells by rabbits. Animals receiving the test substance showed a very slight reduction in antibody production. However, a comparison of the haemagglutinin response in the animals dosed with test substance, negative control animals and positive control animals (azathioprine) indicated that at no time did any of the test substance, 5-amino-0-cresol, induce the degree of immunosuppresssion exhibited by animals treated with azathioprine.Azathioprine, a well known immunosuppressive agent was used as a positive control and was found to suppress both humoral and cellular responses.
The second study was performed on lymphocytes cultures. The capacity of 5-amino-o-cresol to suppress cellular immunological responses was investigated by studying their ability to inhibit the mixed lymphocyte culture response using lymphocytes from non-compatible primates. The toxic action of the test compounds on the lymphocytes in culture was assessed using the trypan blue dye exclusion technique. Leucocytes( final concentration of 1.0E6 cells/ml) were incubated with various concentrations of the chemicals for 5 days at 37°C. Trypan blue was then added to the cultures to give a final concentration of 0.1% and the cultures incubated for a further 10 minutes. The number of dead cells (those that had been stained with trypan blue) was estimated with a haemacytonter and the percentage of viable cells at each concentration of test compound was calculated. The cultures were then incubated for 4 days at 37C after which time they were radioactively labelled by the addition of 10 ul of RPM 1640 medium containing [3H-methyl] thymidine at a concentration of 20 uCi/ml. After a further 24 hours incubation at 37C, the suspensions were cooled and centrifuged. For the first experiment those levels of azathioprine 50, 25 and 10 ug/ml were used. The results showed that optimal suppression without toxicity was given by 10 ug/ml, and this level alone was used in subsequent tests. The test substace inhibited the mixed lymphocyte reaction. Azathioprine, a well known immunosuppressive agent was used as a positive control and was found to suppress the cellular response.
Justification for classification or non-classification
According the results of the key studies (Klimisch 2), the registered substance 4-amino-2-hydroxytoluene can inhibit the mixed lymphocyte reaction. Hence, the No observe Adverse Effect was defined as below 10 µg/mL for lymphocyte culture (in vitromethod) and above 120 mg/kg bw/day on rabbit for the immunosuppresive property (high dose level used in the study) .
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