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EC number: 211-314-4 | CAS number: 638-03-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- As m-toluidine hydrochloride dissociates into m-toluidine and hydrochloride the studies concerning the ecotoxicology of m-toludine are considered relevant for the registration according to REACH.
Data source
Reference
- Reference Type:
- publication
- Title:
- Screening-level hazard characterization: Monocyclic aromatic amines category
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 009
- Bibliographic source:
- U.S. Environmental Protection Agency, September 2009, pp1-32
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Sprague-Dawley rats (13/sex/dose) were administered m-toluidine via gavage at 0, 30, 100 and 300 mg/kg bw/d; males for 42 d, and females from 2 weeks prior to mating to day 3 of lactation (41-53 d)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- m-toluidine
- EC Number:
- 203-583-1
- EC Name:
- m-toluidine
- Cas Number:
- 108-44-1
- Molecular formula:
- C7H9N
- IUPAC Name:
- m-toluidine
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 13 rates per sex and dose
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- males: 42 days
females: 41-53 days - Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 spores/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 13
- Control animals:
- not specified
- Details on study design:
- In a combined repeated-dose/reproductive/developmental toxicity screening test, Sprague-Dawley rats (13/sex/dose) were administered m-toluidine via gavage at 0, 30, 100 and 300 mg/kg bw/d; males for 42 d, and females from 2 weeks prior to mating to day 3 of lactation (41-53 d).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean bw gains during week 1 were significantly lower than controls in the 300 mg/kg bw/d males and the 100 and 300 mg/kg bw/d females. Signs of clinical toxicity, evidence sug-gestive of haemolytic anaemia (decreased erythrocyte counts and haemoglobin con-centration), and effects on various biochemical parameters were observed at 100 and 300 mg/kg bw/d. A statistically significant increase in relative kidney weight in high-dose males was observed. No other changes in organ weights were reported. Histopathological signs in the liver, spleen, and kidney were reported at varying de-grees of severity in both males and females ranging from slight to marked and oc-curring in some instances in a dose-response manner beginning at 100 mg/kg bw/d; signs of marked severity occurred only at 300 mg/kg bw/d. The histological changes reported in the liver and spleen (pigment deposit and extramedullary haematopoie-sis) were considered to be consistent with the reductions in erythrocyte counts and haemoglobin concentrations characteristic of haemolytic anaemia.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean bw gains during week 1 were significantly lower than controls in the 300 mg/kg bw/d males and the 100 and 300 mg/kg bw/d females
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Signs of clinical toxicity, evidence sug-gestive of haemolytic anaemia (decreased erythrocyte counts and haemoglobin con-centration), and effects on various biochemical parameters were observed at 100 and 300 mg/kg bw/d.
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A statistically significant increase in relative kidney weight in high-dose males was observed. No other changes in organ weights were reported.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathological signs in the liver, spleen, and kidney were reported at varying de-grees of severity in both males and females ranging from slight to marked and oc-curring in some instances in a dose-response manner beginning at 100 mg/kg bw/d; signs of marked severity occurred only at 300 mg/kg bw/d. The histological changes reported in the liver and spleen (pigment deposit and extramedullary haematopoie-sis) were considered to be consistent with the reductions in erythrocyte counts and haemoglobin concentrations characteristic of haemolytic anaemia.
- Other effects:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 30 - <= 100 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: not specified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Signs of systemic toxicity in the adults consisted of the following: Mean bw gains during week 1 were significantly lower than controls in the 300 mg/kg bw/d males and the 100 and 300 mg/kg bw/d females. Signs of clinical toxicity, evidence sug-gestive of haemolytic anaemia (decreased erythrocyte counts and haemoglobin con-centration), and effects on various biochemical parameters were observed at 100 and 300 mg/kg bw/d. A statistically significant increase in relative kidney weight in high-dose males was observed. No other changes in organ weights were reported. Histopathological signs in the liver, spleen, and kidney were reported at varying de-grees of severity in both males and females ranging from slight to marked and oc-curring in some instances in a dose-response manner beginning at 100 mg/kg bw/d; signs of marked severity occurred only at 300 mg/kg bw/d. The histological changes reported in the liver and spleen (pigment deposit and extramedullary haematopoie-sis) were considered to be consistent with the reductions in erythrocyte counts and haemoglobin concentrations characteristic of haemolytic anaemia.
- Executive summary:
As m-toluidine HCl dissociates into m-toluidine and hydrochloride the study is considered relevant for the registration according to REACH.
In a combined repeated-dose/reproductive/developmental toxicity screening test, Sprague-Dawley rats (13/sex/dose) were administered m-toluidine via gavage at 0, 30, 100 and 300 mg/kg bw/d; males for 42 d, and females from 2 weeks prior to mating to day 3 of lactation (41-53 d).
Signs of systemic toxicity in the adults consisted of the following: Mean bw gains during week 1 were significantly lower than controls in the 300 mg/kg bw/d males and the 100 and 300 mg/kg bw/d females. Signs of clinical toxicity, evidence sug-gestive of haemolytic anaemia (decreased erythrocyte counts and haemoglobin con-centration), and effects on various biochemical parameters were observed at 100 and 300 mg/kg bw/d. A statistically significant increase in relative kidney weight in high-dose males was observed. No other changes in organ weights were reported. Histopathological signs in the liver, spleen, and kidney were reported at varying de-grees of severity in both males and females ranging from slight to marked and oc-curring in some instances in a dose-response manner beginning at 100 mg/kg bw/d; signs of marked severity occurred only at 300 mg/kg bw/d. The histological changes reported in the liver and spleen (pigment deposit and extramedullary haematopoie-sis) were considered to be consistent with the reductions in erythrocyte counts and haemoglobin concentrations characteristic of haemolytic anaemia.
As the information has been published by the EPA and is publicly available, the studies have been rated as Klimisch 2.
Ths substance has not been classified according to GHS 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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