Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Toxicological information

Acute Toxicity: oral

Currently viewing:

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 for cross-reference:
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
Guideline:
other:
Principles of method if other than guideline:
Standard acute method
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
4-fluoroaniline
EC Number:
206-735-5
EC Name:
4-fluoroaniline
Cas Number:
371-40-4
Molecular formula:
C6H6FN
IUPAC Name:
4-fluoroaniline
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:
other: 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 class
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.