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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
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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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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
- Details on test animals or test system and environmental conditions:
- 13/sex/dose
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Remarks on MMAD:
- not specified
- Details on exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- not specified
- Duration of treatment / exposure:
- males: 52 d
females: 41-53 days - Frequency of treatment:
- once daily
- Duration of test:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/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).
Examinations
- Maternal examinations:
- not specified
- Ovaries and uterine content:
- not specified
- Blood sampling:
- not specified
- Fetal examinations:
- not specified
- Statistics:
- not specified
- Indices:
- not specified
- Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Signs of developmental toxicity included an increase incidence of pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
- Body weight and weight changes:
- not specified
- 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:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- implantation losses observed in all animals at 300 mg/kg bw/d and in 2/10 animals at 100 mg/kg bw/d
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not examined
- Details on maternal toxic effects:
- not specified
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 30 - <= 100 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- 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
- Basis for effect level:
- other: not specified
Maternal abnormalities
- Key result
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- not specified
- Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not specified
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not examined
- Details on embryotoxic / teratogenic effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- Signs of developmental toxicity included an increase incidence of pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
A LOAEL at 100 mg/kg bw/d and a NOAEL at 30 mg/kg bw/d has been assessed. - Executive summary:
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). Clinical observations, organ weights/histopathology, and haematological/biochemical analyses (in males only) were conducted. No deaths in adult rats were reported.
Signs of developmental toxicity included an increase incidence of pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
A LOAEL at 100 mg/kg bw/d and a NOAEL at 30 mg/kg bw/d has been assessed.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.
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.
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