Registration Dossier
Registration Dossier
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EC number: 211-314-4 | CAS number: 638-03-9
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / 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 followed
- Principles of method if other than guideline:
- 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).
- 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 species / strain selection:
- 13/sex/dose
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 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).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- males: 42 days,
females: 41-53 days - Frequency of treatment:
- once daily
- Details on study schedule:
- 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:
- 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).
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- not specified
- Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- not specified
- Postmortem examinations (parental animals):
- not specified
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- increases in implantation losses observed in all animals at 300 mg/kg bw/d and in 2/10 animals at 100 mg/kg bw/d, but none at 30 mg/kg bw/d. No other signs of reproductive toxicity were reported.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
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 (P0)
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- System:
- other: not specified
- Organ:
- other: not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- lack of nursing activity in the dams
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- increase incidence of pup deaths at 30 and 100 mg/kg bw/d due to lack of nursing activity in the dams
- 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 specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- System:
- other: not specified
- Organ:
- other: not specified
Overall reproductive toxicity
- Key result
- Reproductive 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 reproductive toxicity included increases in implantation losses observed in all animals at 300 mg/kg bw/d and in 2/10 animals at 100 mg/kg bw/d, but none at 30 mg/kg bw/d. No other signs of reproductive toxicity were reported.
- 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).
Signs of reproductive toxicity included increases in implantation losses observed in all animals at 300 mg/kg bw/d and in 2/10 animals at 100 mg/kg bw/d, but none at 30 mg/kg bw/d. No other signs of reproductive toxicity were reported.
A LOAEL at 100 mg/kg bw/d and a NOAEL at 30 mg/kg bw/d has been assessed.
No information on the TG is given. As the information has been published by the EPA and is publicly available, the studies have been rated as Klimisch 2.The substance is not 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.
