Registration Dossier
Registration Dossier
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EC number: 211-314-4 | CAS number: 638-03-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- 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:
- A range finding study was conducted to determine the initial dose.
3 doses tested, 10 male animals/dose, single dose by gavage, observation period up to 14 d. - GLP compliance:
- not specified
- Test type:
- standard acute method
- 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
- Specific details on test material used for the study:
- test material was in liquid form
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 10 young adult males per dose
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Single oral applicable via gavage
- Doses:
- Diluted by corn oil:
700 mg/kg bw, 1000 mg/kg bw, 1350 mg/kg bw - No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- The range-finding study was run with 1 rat per dose for levels of 100-3500 mg/kg bw and produced death at 1500 mg/kg bw and above.
Main study:
Single oral application by gavage to 10 male rats and observation for 14 days. The surviving rats were weighed and observed during a 14-day recovery period and then sacrificed. The LD50 value was calculated from the mortality data using probit analysis of DJ Finney, 1971, Cambridge University Press. - Statistics:
- probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 922 mg/kg bw
- 95% CL:
- >= 792 - <= 1 054
- Remarks on result:
- other: clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss
- Mortality:
- 1350 mg/kg bw: 10/10 all deaths occurred wintin 2 days after dosing
1000 mg/kg bw: 6/10 all deaths occurred within 3 days after dosing
700 mg/kg bw: 1/10 death occurred 2 days after dosing - Clinical signs:
- other: clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss
- Other findings:
- not applicable
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 10 male young adult rats were given one dose of m-touidine diluted in corn oil at concentrations of 700 mg/kg bw, 1000 mg/kg bw and 1350 mg/kg bw resulting in an LD50 of 922 mg/kg bw. All deaths occurred within 3 days after dosing.
Clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss. - Executive summary:
As m-toluidine HCl dissociates in solution into m-toluidine and hydrochloride the study was considered relevant for the registration according to REACH.
In 1980 DuPont conducted an acute toxicity study via gavage at 3 doses (700 mg/kg bw, 1,000 mg/kg bw and 1,350 mg/kg bw) and 10 young adult male rats per dose. An LD50 at 922 mg/kg bw had been assessed.
The experimental study was not conducted according to an OECD test guideline and is not publicly available, thus the study has been rated as Klimisch 3 (not reliable).
As the study has to been rated as Klimisch 3, the study cannot be used for the classification for m-toluidine HCl.
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