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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Reaxys ID : 742030
Year:
2011
Bibliographic source:
Reaxys by Elsevier Properties SA; Okazaki, Yoshimasa; Yamashita, Kotaro; Ishii, Hiroyuki; Sudo, Masato; Tsuchitani, Minoru; Journal of Applied Toxicology; vol. 23; nb. 5; (2003); p. 315 - 322
Reference Type:
review article or handbook
Title:
RTECS Number: BY1575000
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances):- Journal of Applied Toxicology (John Wiley & Sons, Ltd., Oldlands Way Bognor Regis West Sussex, PO22 9SA England) V.1- 1981- Volume(issue)/page/year: 23,315,2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Standard acute method
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 4-fluoroaniline
- Molecular formula: C6H6FN
- Molecular weight: 111.12
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male

Administration / exposure

Route of administration:
other: peroral
Vehicle:
olive oil
Doses:
100 - 1000 mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Rats were treated with title compound; body weights recorded on days 2, 4, 8, 15, 16 post-dose; mortality and clinical signs observed at 30 min and 5 h after dosing and once a day for following 15 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: TDLo
Effect level:
600 mg/kg bw
Based on:
dissolved
Remarks on result:
other: Other details not available
Clinical signs:
Spinal Cord - other degenerative changes
Peripheral Nerve and Sensation - flaccid paralysis without anesthesia (usually neuromuscular blockage); recording from peripheral motor nerve; structural change in nerve or sheath
Behavioral - alteration of classical conditioning
Lungs, Thorax, or Respiration - dyspnea; cyanosis
Nutritional and Gross Metabolic - weight loss or decreased weight gain

Other findings:
Rats treated with 4-fluoroaniline showed cyanosis between days 1 and 4 and irregular respiration on day 1; mean body weights of treated rats
decreased on day 2 and were significantly lower than those of control on days 4, 8, 15 and 16

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral toxicity (TDLo) of 4-fluoroaniline to rat was examined at dose concentration of 600 mg/kg of body weight.
Executive summary:

The potential for neurotoxicity after a single oral dose of 4-fluoroaniline (4-FA), given to rats, was investigated at or near the lethal dosage level. Hindlimb paralysis was found clinical observation, with the maximum incidence of 100% in 4-FA groups.

Oral toxicity (TDLo) of 4-fluoroaniline to rat was examined at dose concentration of 600 mg/kg of body weight.