Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.844 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: NAOEL
DNEL value:
50.629 mg/m³
AF for intraspecies differences:
5
Justification:
worker
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:
0.479 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
DNEL value:
28.715 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker
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:
high hazard (no threshold derived)

Additional information - workers

Toxicokinetics

Details on absorption - The absorption capacity of α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4) through the oral, inhalation and derma route is low given the use of the chemical mostly in the preparation of inks, toner s and pigments. Though dermal absorption and inhalation of the particulates is a possibility (given the nature of use); it is unlikely that the chemical will penetrate the skin and enter inside the living system. However, entry into the respiratory tract in the absence of use of protective masks is a possiblity.

Details on dostribution in tissues - Since α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4) has poor/moderate water solubility compared toits solubility in organic solvents; distribution to the various parts of the body through blood will be less significant compared to distribution through lipids.

Details on excretion - The chemical α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4) has a molecular weight range of 487.64. It is therefore expected that the excretion process through urine would be faster as the molecular weight of the substance is > 300 and this is a favourable value for excretion via the urine route. Also, given the greater solubility of the chemical in the lipds, some of the chemical is also likely to be excreted through the feaces or bile.

Acute toxicity

Based upon the data for the target chemical as well as using supporting study it can be concluded that Solvent Blue 4 is unlikely to be acutely toxic via the oral, inhalation and dermal route within the dose limits mentioned in the data end points. Thus, the chemical is not classified for Acute Toxicity by ay of the ruotes of exposure (Oral, Inhalation and Dermal).

 

Irritation / corrosion

Based upon the data for the target chemical (Solvent Blue 4) in the key study as well as using the supporting study data, it can be concluded that Solvent Blue 4 is unlikely to be a skin irritant though it is an eye irritant in category 1.

 

Sensitisation

The substance α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4 with < 0.1 % Michler's Ketone) was classified as sensitizing to skin of Guinea pig based upon the prediction value of the key study

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.208 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
DNEL value:
24.97 mg/m³
AF for intraspecies differences:
10
Justification:
general polulation
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:
0.239 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
DNEL value:
28.715 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:
0.12 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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
DNEL value:
14.357 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:
high hazard (no threshold derived)

Additional information - General Population

DNEL derivation

α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4) containing less than 0.1% Michler’s Ketone is non acutely toxic by oral, dermal and inhalation route, does not show irritation effect to skin but has corrosive effect on eyes, 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 repeated dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOEL of 905.37 mg/kg bw/d in oral category.