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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Remarks:
other: Parent fertility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from RTECS database
GLP compliance:
not specified
Species:
mouse
Strain:
not specified
Sex:
female
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
Litter observations:
litter size (e.g. # fetuses per litter; measured before birth)
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)
Reproductive - Effects on Newborn - live birth index (measured after birth) Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)
Reproductive effects observed:
not specified
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.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
9 600 mg/kg bw/day
Study duration:
subacute
Species:
mouse
Additional information
Short description of key information:
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. This indicates that 4-nitroaniline shall not exhibit toxic effects to mouse by the oral route below the
above mention dose.

Justification for selection of Effect on fertility via oral route:
LOEL value of 4-nitroaniline observed was 9600 mg/kg/day. Therefore NOAEL value of 4-nitroaniline is bound to be less than 9600 mg/kg/day.

Effects on developmental toxicity

Description of key information
Mammal rat foetus 6-19 day(s) after conception show  Developmental Abnormalities - musculoskeletal system if subatance 4-nitroaniline reaches at LOEL (lowest observed effect concentration) concentration 3500 mg/kg.
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from RTECS database
GLP compliance:
not specified
Species:
rat
Strain:
not specified
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:
6-19 day(s) after conception
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
3 500 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: fetotoxicity
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
Mammal rat foetus 6-19 day(s) after conception show Developmental Abnormalities - musculoskeletal system if subatance 4-nitroaniline reaches a LOEL (lowest observed effect concentration) concentration of 3500 mg/kg.
Executive summary:

Mammal rat foetus 6-19 day(s) after conception show Developmental Abnormalities - musculoskeletal system if subatance 4-nitroaniline reaches at LOEL (lowest observed effect concentration) concentration 3500 mg/kg.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
LOEL value of 4-nitroaniline observed was 3500 mg/kg/day. Therefore NOAEL value of 4-nitroaniline is bound to be less than 3500 mg/kg/day.

Justification for classification or non-classification

4- nitro aniline do not have reproductive toxcity properties as per th studies mentioned in the end point. Regarding the developmental toxicity effect; abnormalities have been observed in the study in the form of musculoskeletal system. Thus we can consider the substance for reproductive toxicity in developemental category but will require more studies to prove the same.

Additional information