Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Authoritative data base
Title:
Danish QSAR study for CAS No.: 371-40-4
Author:
Danish EPA Model
Year:
2012
Bibliographic source:
QSAR predictions by Danish Environmental Protection Agency (EPA)model powered by OASIS database:Commercial

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Modelling database
Principles of method if other than guideline:
Teratogenicity (FDA TERIS), human: Multicase model A49
GLP compliance:
no

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:
other: human
Strain:
other: Not applicable

Administration / exposure

Route of administration:
other:
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
no data
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Duration of test:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
no data
Basis:

No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
4-fluoroaniline gives negative results in a Unscheduled DNA synthesis test conducted in Rat hepatocytes
Executive summary:

4-fluoroaniline gives negative results in a Unscheduled DNA synthesis test conducted in Rat hepatocytes