Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.224 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
other: NOAEL
Value:
73.436 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.694 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
Value:
41.65 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Toxicokinetics :

There is little information available on the complete toxico-kinetics (absorption, distribution, metabilism and excretion) of the target chemical N,N-dimethyl-p-toluidine. The chemical is though known to have effects on the blood count and haematopoietic system of human beings that have been exposed to the chemical. However considering the various metabolites that are formed with N,N-dimethyl-p-toluidine, its low bio-accumulation factor (BCF) of 33, N,N-dimethyl-p-toluidine is likely to exhibit low bio-accumulation potential upon exposure to low dose levels.

Acute Toxicity :

The substance N,N-dimethyl-p-toluidine is toxic via oral. inhalation and dermal route and hence classified as acute toxicity category 3( for Oral and dermal) and Acute toxicity category 2 (for Inhalation) as per CLP criteria.

Skin and Eye irritation :

The substance N,N-dimethyl-p-toluidine is not irritating to skin and eye of rabbit and hence not classified as skin and eye irritant as per CLP criteria

Sensitization:

The substance N,N-dimethyl-p-toluidine is not sensitizing skin rabbit and guinea pig and hence not classified as sensitizing s per CLP criteria

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.302 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
other: NOAEL
Value:
36.217 mg/m³
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.347 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
41.65 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.174 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
20.825 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL derivation

 

N,N-dimethyl-p-toluidine shows acute toxicity to oral and inhalation, but is not irritant to skin and eye, is not genotoxic and is not a developmental or reproductive toxin.

 

In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.

 

In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.

 

A standard approach to deriving DNEL values would be to use the reproductive toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 83.3 mg/kg bw/d in oral category.