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EC number: 408-090-7 | CAS number: 100418-33-5 METHYLGELB
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Remarks:
- The study was not performed under GLP conditions, but a statement of the quality assurance unit of the test facility is included. The generated data are considered reliable and scientifically sound.
Test material
- Reference substance name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- EC Number:
- 408-090-7
- EC Name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- Cas Number:
- 100418-33-5
- Molecular formula:
- C9H12N2O3
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)amino]ethan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- red powder
Batch # : BRA1/315
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Carboxymethylcellulose (CMC) in water
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- successful mating was verified by vaginal smear and/or vaginal plug analysis
- Duration of treatment / exposure:
- from day 6 to day 15 of gestation
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- control group
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 60 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Animals were observed at least once daily for clinical signs during the entire treatment period. Body weights were recorded at days 0, 6 11, 16 and 20 of gestation. Food consumption was measured for the intervals day 0-6, 6-11, 11-16 and 16-20 and calculated for the entire study period (0-20).
- Ovaries and uterine content:
- The ovaries and the intact uterus (prepared by caesarean sections) were removed and the presence of resorption sites (early, late) and foetuses (live or dead and birth position) were examined. The number of implantation sites and of corpora lutea were also determined. In addition placenta weights were recorded.
- Fetal examinations:
- Each live foetus was weighed, sexed and examined for gross external malformations. After fixation and staining a skeletal and a visceral examination of the foetuses was performed on 50% of the foetuses each.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Gross pathological findings:
- no effects observed
- Other effects:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: highest dose tested
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were noted in dams or for the foetal development up to the highest test dose administered in this rat teratogenicity study. Consequently, a NOAEL of 60 mg/kg bw/day for both the parental and the developmental toxicity of Hydroxyethyl-2-nitro-p-toluidine is deduced from this study. Based on these findings one can conclude that Hydroxyethyl-2-nitro-p-toluidine, at the investigated doses, does not acts as a developmental toxin.
- Executive summary:
Hydroxyethyl-2-nitro-p-toluidine, in a constant volume of 10 ml/kg bw (0.5% CMC as vehicle), was administered once daily by oral gavage to groups of 24 pregnant (successful mating was verified by vaginal smear and/or vaginal plug analysis) Sprague Dawley Him:OFA rats at doses of 10, 30 and 60 mg/kg bw/day from day 6 to day 15 of gestation. A concurrent control group received the vehicle (0.5 % CMC) alone. Animals were observed at least once daily for clinical signs during the entire treatment period. Body weights were recorded at days 0, 6 11, 16 and 20 of gestation. Food consumption was measured for the intervals day 0-6, 6-11, 11-16 and 16-20 and calculated for the entire study period (0-20). On day 20 of gestation, all mated females were killed under deep CO2-anesthesia by exsanguination from the thoracid aorta and a complete autopsy and a macroscopic examination of the organs was carried out. The ovaries and the intact uterus (prepared by caesarean sections) were removed and the presence of resorption sites (early, late) and foetuses (live or dead and birth position) were examined. The number of implantation sites and of corpora lutea were also determined. Each live foetus was weighed, sexed and examined for gross external malformations. After fixation and staining a skeletal and a visceral examination of the foetuses was performed on 50% of the foetuses each. In addition placenta weights were recorded. Stability, homogeneity and concentrations of the solutions of Hydroxyethyl-2-nitro-p-toluidine in the vehicle were not analytically confirmed. However, the suitability of this vehicle has been demonstrated already in other studies. No treatment-related effects in dams were noted with regard to clinical observations and post-mortem findings. The body weight, body weight gain and the food consumption were not affected by the treatment with Hydroxyethyl-2-nitro-p-toluidine. Gross necropsy revealed no treatment-related effects. The placenta weights, the number of corpora lutea, and the number of implantations were similar to control values in all treated groups. There were no treatment-related effects with regard to litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment-related findings. Neither a statistically significant difference nor a dose-dependent increase in any malformation was noted. The observed variations represented common findings for the rat strain used and were within the spontaneous variation range and/or revealed no dose-response relation.
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