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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
Key value for chemical safety assessment
Effects on fertility
Additional information
No data are available to specifically evaluate the reprotoxic effect of the 4 -amino-3-methylphenol or its sulfate form. During the 90 days toxicity study performed on 4-amino-m-cresol sulfate, male and female reproductive organs of rats were observed. No effects were reported, thus no effect on the reproductive performance could be expected.
Effects on developmental toxicity
Description of key information
According to the result of the key study (GLP compliant, OECD guideline 414 method, Klimisch 2), the test item 4 -amino-3 -phenol sulfate did not induced maternotoxicity or embryotoxicity on this teratogenicity test. The No Observe Adverse Effect Level NOAEL was defined as the high dose level, 80 mg/kg/day for the 4 -amino-m-cresol hemisulfate, corresponding to a NOAEL of 56.8 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 56.8 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The key study is a teratogenicity test wich was performed accordingly with OECD GLP principle and OECD guidelmine 414 method. The study was quoted as Klimisch 1. Female BOR:WISW-SPF TNo were used, they were paired with male. The presence of sperm in vaginal smear was considered as Day 0 of pregnancy. Each treatment and control group contained 24 mated females. Animals were treated once daily by oral gavage at dose levels of 0, 10, 40 and 80 mg/kg bw/day (Dose volume: 10 mL/kg bw) from Day 5 through to Day 15 of gestation. All animals were observed daily for mortality and clinical observations. Body weights were recorded. On gestation Day 20, the dams were sacrificed and examined for visceral gross pathology, cesarean-sectioned, and evidence of maternal and developmental toxicity. Numbers of live and dead fetuses were determined. Each fetus was weighed, sexed and examined externally. Fetuses were examined for visceral and skeletal alterations.
No mortality was observed in the study. No treatment-related effects in dams were noted with regard to clinical observations and postmortem findings. The body weight and the food consumption were not affected by the treatment. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to uterus and placenta weights, the number of corpora lutea, and implantations. There were no treatment related effects with regard to reproduction e.g. litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the fetuses revealed no treatment related findings. Neither a statistically significant difference as compared to the concurrent control nor a dose-dependent increase in any malformation or variation was noted.
In conclusion, administration of 1-Hydroxy-3-methyl-4-aminobenzol-sulfat to female BOR:WISW-SPF TNO rats during Day 5-15 of presumed gestation, at dose levels of 0, 10, 40 and 80 mg/kg bw/day by oral gavage revealed a NOAEL of 80 mg/kg bw/day for maternal and developmental toxicity.
Based on this result on the sulfat form, the converted NOAEL for the registered substance 4 -amino-3-methylphenol was defined at 56.8 mg/kg bw/day according the read-across analogy approach.
Toxicity to reproduction: other studies
Additional information
According to the result of the key study (GLP compliant, OECD guideline 414 method, Klimisch 2), the test item 4 -amino-3 -phenol sulfate did not induced maternotoxicity or embryotoxicity on this teratogenicity test. The No Observe Adverse Effect Level NOAEL was defined as the high dose level, 80 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 56.8 mg/kg bw/day.
No data are available to specifically evaluate the reprotoxic effect of the 4 -amino-3-methylphenol or its sulfate form. During the 90 days toxicity study (Klimisch 1, OECD guideline 408 method, GLP compliant), performed on 4-amino-m-cresol sulfate, male and female reproductive organs of rats were observed (prostate gland, testes (l+ r), ovaries (l+ r) and uterus…). No effects were reported, thus no effect on the reproductive performance could be expected. The NOAEL (No observe adverse effect level) was defined as 60 mg/kg/day (for other effects than effects on reproductive parameters). Based on this result on the sulfate form, the converted NOAEL for the registered substance 4 -amino-3-methylphenol was defined at 42.6mg/kg bw/day.
For reproductive toxicity the NOAEL for developmental toxicity should be considered: 56.8 mg/kg bw/day.
Justification for classification or non-classification
According to the result of the key study (GLP compliant, OECD guideline 414 method, Klimisch 2), the test item 4 -amino-3 -phenol sulfate did not induced maternotoxicity or embryotoxicity on this teratogenicity test. The No Observe Adverse Effect Level NOAEL was defined as the high dose level, 80 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 56.8 mg/kg bw/day.
Additional information
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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