Registration Dossier
Registration Dossier
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EC number: 203-403-1 | CAS number: 106-49-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (Peer reviewed source OECD-SIDS)
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 973
- Reference Type:
- secondary source
- Title:
- p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.
- Author:
- OECD
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications
Materials and methods
- Principles of method if other than guideline:
- Dermal application of 464 - 1470 mg/kg bw moistened p-toluidine (exposure time not mentioned) to 5 rabbits/dose group
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- p-toluidine
- EC Number:
- 203-403-1
- EC Name:
- p-toluidine
- Cas Number:
- 106-49-0
- Molecular formula:
- C7H9N
- IUPAC Name:
- 4-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): p-toluidine
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Duration of exposure:
- Exposure time was not mentioned
- Doses:
- 464, 691, 1000, 1470 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 890 mg/kg bw
- 95% CL:
- 622 - 1 272
- Mortality:
- 464 mg/kg bw: no symptoms, mortality: 1/5 at day 4
691 mg/kg bw: onset of symptoms 4-12 hours post application, mortality: 1/5 day 4, survivors recovered one day post exposure
1000 mg/kg bw: onset of symptoms 0-4 hours post application, mortality: 3/5 12-24 hours and day 4 post exposure, respectively; survivors recovered one day post exposure
1470 mg/kg bw: onset of symptoms 0-4 hours post application, mortality: 5/5 12-24 hours and day 4 post exposure, respectively - Clinical signs:
- other: hypoactivity, muscular weakness, convulsions and vocalisation just prior to death dermal irritation: moderate to severe erythema, mild edema, focal chemical burns, subdermal hemorrhages
- Gross pathology:
- survivors: no significant findings
decedents: granular livers
Applicant's summary and conclusion
- Executive summary:
Industrial Bio-Test Laboratory Inc (1973).
Dermal application of 464 - 1470 mg/kg bw moistened p-toluidine (exposure time not mentioned) to 5 rabbits/dose group, resulted in an LD50-value of 890 mg/kg bw. Signs of intoxication from day 4 post exposure in the lowest dose group and within 4 hours post exposure in the highest dose group were hypoactivity, muscular weakness, convulsions and vocalisation just prior to death which occurred in all dose groups. Additionally, moderate to severe erythema, mild edema, focal chemical burns and subdermal hemorrhages were seen in the skin of the rabbits. Pathological investigations showed granular livers in the decedents whereas from survivors no significant findings were noted
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