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EC number: 223-460-6
CAS number: 3905-19-9
The substance does not cause treatment-related adverse effects up to the
limit dose upon subacute oral exposure. This assessment is based on a
GLP and OECD 407 compliant study with Pigment Red 166 (CAS 3905-19-9)
(Vuos 2009b) and a GLP and OECD 422 compliant study with Pigment Red 220
(CAS 68259-05-2) (BASF 2012b).
The table below gives an overview on the relevant parameters regarding
systemic availability and subacute toxicity on the pigments and the
amine building blocks. It supports the general argument that there is no
systemic availability upon ingestion for disazo condensation red
pigments. This was discussed in detail in the section on toxicokinetic
0.5 – 1
(calculated from solubilities)
1.7 - 2.1
acute oral tox (LD50 in mg/kg bw, rat)
> 10 000
NOAEL = 1000 (OECD 407)
NOAEL = 1000 (OECD 422)
CAS of amine A
CAS amine B
ca 1500 (mice)***
Other repeated dose oral toxicity data
NOAEL = 16 mg/kg bw (OECD 408, CAS 106-50-3)*
Mortality at 0.3% in the diet, 90-day range-finder study*
NOEL = 60 mg/kg bw (OECD 422, CAS 89-63-4)**
The first key study is a valid investigation of the toxicological
effects resulting from repeated oral-gavage administration of the test
item Pigment Red 220 according to OECD guideline 422 and GLP to rats
(BASF 2012b). It is chosen because it is of slightly longer duration
than the subacute oral toxicity study with Pigment Red 166. The
substance was administered as a suspension in Milli-Q-water as vehicle
at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls
received the vehicle only. It was administered to male rats for 29 days
and to female rats for 14 days prior to pairing, through the pairing and
gestation periods until the F1 generation reached day 4 post partum.
Treatment with the test item up and including 1000 mg/kg bw/day did not
reveal any clinical signs or histological findings and did not affect
reproduction and development. All dose-treated males and females had
dose-related reddish discolored feces during the treatment period. This
finding is considered to be a typical effect resulting from oral
administration of a red dyestuff and not adverse. Based on these results
a general NOAEL (No Observed Adverse Effect Level) was considered to be
1000 mg/kg body weight/day. Considering reporting details, adherence to
guideline and GLP status, the study is valid without restrictions.
The second key study is a valid subacute oral toxicity study with
a 14 -day recovery period that was performed according to GLP and OECD
testing guideline 407 (Vuos 2009b).
The study is considered to be valid with restrictions because it
lacks certain reporting details. Individual data for animals are not
provided, no grading scheme for histopathology was applied and
historical control data is not provided. It could be retrieved upon
request from the CRO.
Wistar rats of SPF quality were used for testing. The test
substance was administered as suspension in olive oil using a stomach
tube; oral application of rats was made daily. The study includes four
main groups and two satellite groups of animals. Each main group
consisted of 5 males and 5 females; each satellite group consisted of 5
males and 5 females. Main groups contained 3 treated groups (doses 160,
400, 1000 mg/kg of body weight /day) and one control group (vehic1e
only). The satellite groups contained one control group (vehicle only)
and one treated group (l000 mg/kg/day). The administration period lasted
28 days. After that animals of main groups were sacrificed and satellite
animals were observed for the next 14 days without treatment. During the
28-day study clinical observation and health status control were
performed daily. The body weight, food consumption were measured weekly
and the detailed clinical observation was carried out in the same time
interval. Water consumption was measured twice a week. Before the end of
study the functional observation was accomplished. The study was
finished by urinalysis, haematological and biochemical analysis, and
gross necropsy of animals. The selected organs for weighing and
histopathology examination were removed.
No treatment-related effects adverse were observed. Two animals of
the high dose group showed reactive hyperplasia in paraaortic lymph
nodes. This is a finding that was communicated by the laboratory to
generally occur 0 - 2 times per study.
Overall, no hazard is identified for repeated dose oral exposure to
disazocondensation red pigments.
Considering the high molecular weights (>> 500 g/mol) and the poor
solubility in water and octanol, there is also no concern for systemic
uptake after skin contact.
An inhalation hazard arises from dust exposure at concentrations
exceeding general exposure limits for inhalable dust. The pigments are
considered to behave like nuisance dust and would cause primarly local
effects due to lung clearance overload situations.
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for
classification purposes under 67/548/EEC. No serious irreversible
effects were observed at dose levels of less than 150 mg/kg bw upon
subacute exposure. As a result the substance is not considered to be
classified for repeated dose toxicity under Directive 67/548/EEC, as
amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No.
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. There were no
significant toxic effects at doses of less than 300 mg/kg bw upon
subacute oral exposure in rats. As a result the substance is
not classified for repeated dose toxicity under Regulation (EC) No.
1272/2008, as amended for the third time in Directive EC 618/2012.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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