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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Parent fertility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
No information
Year:
1987
Bibliographic source:
Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year: 7,29,1987
Reference Type:
review article or handbook
Title:
RTECS Number: BY7000000
Author:
RTECS database
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances); TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year: 7,29,1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from RTECS database
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-nitroaniline
EC Number:
202-810-1
EC Name:
4-nitroaniline
Cas Number:
100-01-6
Molecular formula:
C6H6N2O2
IUPAC Name:
4-nitroaniline
Details on test material:
- Name of test material (as cited in study report): 4-nitroaniline
- Substance type: Organic
- Physical state: solid

Test animals

Species:
mouse
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6-13 day(s) after conception
Control animals:
not specified

Examinations

Litter observations:
litter size (e.g. # fetuses per litter; measured before birth)

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
LOEL
Effect level:
9 600 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured before birth) Reproductive - Effects on Newborn - live birth index (measured after birth) Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)

Results: F1 generation

Details on results (F1)

Reproductive - Effects on Newborn - live birth index (measured after birth) Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Reproductive toxicity LOEL (low observed effect level) of 4-nitroaniline was observed at dose concentration of 9600 mg/kg. in a 6-13 day(s) after conception to female mouse by the oral route. There was reduced weight gain observed in new borns.
Executive summary:

Reproductive toxicity LOEL (low observed effect level) of 4-nitroaniline was observed at dose concentration of 9600 mg/kg. in a 6-13 day(s) after conception to female mouse by the oral route. There was reduced weight gain observed in new borns.