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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Description of key information
According to the result of the key study (Klimisch 1, OECD guideline 408 method, GLP compliant), the substance 1-Hydroxy-3-methyl-4-aminobenzol-sulfate induced slight toxicity in rats treated for 90 days by oral route. Effects observed were: increase in absolute spleen weight in the high dose group. The NOAEL (No observe adverse effect level) was defined as 60 mg/kg/day. Based on this result on the sulfate form, the converted NOAEL for the registered substance 4 -amino-3-methylphenol was defined at 42.6 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 42.6 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
One study quoted as Klimisch 1 was available to assess the potential toxicity of 1-Hydroxy-3-methyl-4-aminobenzol-sulfate. The test was performed according to OECD guideline 408 method and was GLP compliant. Wistar rats were used and was assignated to 20 animals per sex per dose which were 0 (vehicle), 15, 60, 120 mg/kg day. Rats were treated orally by gavage daily, for a period of 90 days with a volume dose of 10 mL/kg. An additional groups of 5 animals per sex per dose was used as recovery group for high dose level after a 4 weeks treatment free period.
Animals were observed twice daily for mortality/morbidity and once daily for clinical abnormalities. Body weight and food consumption were recorded weekly. A detailed ophthalmological investigation as well as an evaluation of auditory function and reflexes, according to a modified Irwin screen test (FOB) were performed on 5 animals/sex/group with special regard to awareness, co-ordination and autonomous nervous system functions. The investigations were conducted prior to treatment, after week 6, at the end of the treatment period and at the end of week 17 (recovery groups). Haematology and clinical chemistry evaluations were performed in 20 animals/sex/dose at Day 0, and after 6 and 13 weeks in all dose groups and after 17 weeks in the recovery group. The urinalysis was performed in the 5 animals/sex/dose at Day 0, and after 6 and 13 weeks in all dose groups and after 17 weeks in the recovery group. At the end of the treatment period, all animals were killed and subjected to a detailed necropsy. Recovery group animals were sacrificed after Week 17 of the study. Selected organs were weighed. A wide range of organs/tissues of the control and high dose animals was examined histopathologically. In addition, all gross lesions noted were examined microscopically.
The only test substance related finding was an increase in absolute spleen weight in high dose females (statistically significant) and in high dose males (not statistically significant). In the high dose recovery group an increase in absolute spleen weight was not observed. No treatment related effects were observed in body weight gain, food efficiency, urinalysis, hematology, clinical chemistry, gross pathology and histopathology parameters at any dose levels.
Based on above, oral administration of to male and female Wistar (BOR: WISW) rats at dose levels of 15, 60 and 120 mg/kg bw by oral gavage for a period of 90 days revealed a NOAEL of 60 mg/kg bw.
Based on this result on the sulfat form, the converted NOAEL for the registered substance 4 -amino-3-methylphenol was defined at 42.6 mg/kg bw/day (calculation based on molecular weight).
Justification for classification or non-classification
According to the result of the key study (Klimisch 1, OECD guideline 408 method, GLP compliant), the substance 1-Hydroxy-3-methyl-4-aminobenzol-sulfate induced slight toxicity in rats treated for 90 days by oral exposure as increase in absolute spleen weight in the high dose group. The NOAEL (No observeadverse effect level) was defined as 60 mg/kg/day.
Based on this result on the sulfat form, the converted NOAEL for the registered substance 4 -amino-3-methylphenol was defined at 42.6 mg/kg bw/day (calculation based on molecular weight).
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.