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EC number: 229-355-1
CAS number: 6486-23-3
A 90-day toxicity study in Fischer F344 rats was performed with the test
item. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000
mg/kg/day by oral gavage in corn oil for 90 days. The study included
additional control and high dose groups of 6 males and 6 females each
analyzed after a 4-week recovery period. All animals survived until
scheduled termination without any toxic signs in life. In haematology,
clinical biochemistry and urinalysis some scattered significant
differences, altogether without a clear dose response and all only minor
in severity, were noted. Post mortem examination including
histopathology did not reveal any test substance related toxic
alterations. The test substance caused elevated liver weights in the
high dosed females. As there were no corresponding histopathological or
clinical-biochemical alterations found, the most likely interpretation
is an adaptive response by enzyme induction. No parallel trend was
present in the males. The effects did not persist until the end of the
recovery period. No other test substance-related effect was noted. The
No-observed-adverse-effect-level (NOAEL) of the test item was 1000 mg/kg
bw/day in both sexes.
Only parameters are listed for which a
significant difference between at least one treatment group and the
respective control group was observed for at least one sex. All
parameters not showing significant differences are omitted from the
tables. A significant difference to the respective control group is
indicated by a grey background.
low dose(% of the negative controls)
mid dose(% of the negative controls)
high dose(% of the negative controls)
high doseafter recovery(% of the negative controls)
red blood cell count(males)
mean cell volume(males)
mean corpuscular haemoglobin conc.(females)
Clinical biochemical results.
high doseafter recovery
total amount(females, % of the negative controls)
pH(females; control: pH 7.1; control recovery: pH 7.3)
thymus(males, absolute weight)
thymus(males, organ weight/body weight ratio)
thymus(males, organ weight/brain weight ratio)
brain(males, absolute weight)
liver(females, absolute weight)
liver(females, organ weight/body weight ratio)
liver(females, organ weight/brain weight ratio)
ovaries(females, absolute weight)
EC-Guideline 2001/59/EC, B.26.,
OECD-Guideline 408, 21 September 1998.
Based on the results of a 14-day dose
range finding study (which was part of the present study), the dose
levels for this 90-day oral gavage study were selected to be 0, 50, 200
and 1000 mg/kg/day.
The test substance, formulated in corn
oil, was administered daily for 90 days orally by gavage to SPF-bred
Fischer F344/DuCrl rats. One control group (plus a control satellite
group) and 3 test substance treated groups (plus a high dose satellite
group) were tested, each consisting of 10 males and 10 females (6 males
and 6 females in the satellite groups).
Chemical analyses of formulations were
conducted twice in the in-life phase of the study to assess
concentration and homogeneity.
The following parameters were
evaluated: Clinical signs (daily plus weekly in more detail), functional
observations (terminally), ophthalmoscopy (initial and terminal), body
weights and feed consumption (weekly), haematology plus clinical
biochemistry plus urinalysis (terminal), necropsy, organ weights and
Accuracy and homogeneity of test
substance preparations in corn oil were demonstrated by analyses.
All animals survived until scheduled
termination without any toxic signs in life. In haematology, clinical
biochemistry and urinalysis some scattered significant differences,
altogether without a clear dose response and all only minor in severity,
were noted. Post mortem examination including histopathology did not
reveal any test substance related toxic alterations. Liver weights of
the females were elevated with a dose dependency, which may indicate an
adaptive response rather than a toxic effect.
A frequently noted yellow stain of the
gastrointestinal contents and of the faeces is attributed to the
presence of the administered test substance itself and not regarded as a
Discussion and Conclusion
The test substance caused elevated
liver weights in the high dosed females. As there were no corresponding
histopathological or clinical-biochemical alterations found, the most
likely interpretation is an adaptive response by enzyme induction. No
parallel trend was present in the males.
No other test substance related effect
The effects did not persist until the
end of the recovery period.
(NOAEL) of the test substance was at 1000 mg per kg body weight in both
The study used as source investigated C.I. Pigment Yellow 74. The study results of the source compound were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
The test item did not cause adverse effects in a repeated dose study in
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