Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
RTECS Number: BY1575000
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances):- "Prehled Prumyslove Toxikologie; Organicke Latky," Marhold, J., Prague, Czechoslovakia, Avicenum, 1986 Volume(issue)/page/year: -,611,1986
Reference Type:
review article or handbook
Title:
DPIM: FFY000
Author:
Richard J. Lewis, Sr.
Year:
2007
Bibliographic source:
SAX (Sax's Handbook of Dangerous Industrial Materials):85JCAE ;Prehled Prumyslove Toxikologie; Organicke Latky Marhold, J., Prague, Czechoslovakia.:  , Avicenum 1986, 611.
Reference Type:
review article or handbook
Title:
Dose doc.no. : F60
Author:
RSC Publishing
Year:
2011
Bibliographic source:
Dictionary of Substances and their effects (DOSE);Marhold, J. V. Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku 1972, 95, Prague, Czechoslovakia

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Standard Draize test
GLP compliance:
not specified

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:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
2 mg
Duration of treatment / exposure:
24hr
Observation period:
no data
Number of animals:
no data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Reversibility:
no data
Remarks on result:
other: Severe irritation

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2 mg of 4-fluoroaniline caused severe irritation to rabbit skin during a 24 hr exposure as evaluated by a Standard Draize test
Executive summary:

2 mg of 4-fluoroaniline caused severe irritation to rabbit skin during a 24 hr exposure as evaluated by a Standard Draize test.