Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Weight of evidence
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Weight of evidence
Title:
Toxicokinetics
Author:
Sustainability Support Services (Europe) AB
Year:
2012
Bibliographic source:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol
EC Number:
229-851-8
EC Name:
α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol
Cas Number:
6786-83-0
Molecular formula:
C33H33N3O
IUPAC Name:
bis[4-(dimethylamino)phenyl][4-(phenylamino)naphthalen-1-yl]methanol

Test animals

Species:
other: unspecified
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: estimation
Vehicle:
unchanged (no vehicle)

Results and discussion

Toxicokinetic / pharmacokinetic studies

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 distribution 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.

Metabolite characterisation studies

Metabolites identified:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: non bioaccumulation potential based on estimation results
Under normal conditions of use and exposure, there is limited possibility of the chemical Solvent Blue 4 entering into the living system and being bio-accumulative.
Executive summary:

Under normal conditions of use and exposure, there is limited possibility of the chemical Solvent Blue 4 entering into the living system and being bio-accumulative.