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EC number: 225-590-9
CAS number: 4948-15-6
Sub-chronic: Equivalent to OECD 408; no GLP; rat;
doses: 10,000 and 50,000 ppm. No treatment-related deaths. NOAEL 50,000
Sub-acute: OECD 407; GLP; rat; doses: 750, 3750, and
15,000 ppm. No mortality. NOAEL 1500 mg/kg bw/day.
GROUP MEAN HAEMATOLOGICAL VALUES AND STANDARD DEVIATIONS (S.D.) - FEMALES
* = significantly different from corresponding control group value p = 0.05
** = significantly different from corresponding control group value p = 0 .01
- = not applicable
No studies with repeated administration are available for the test
substance. However, one 90-day and three 28-day studies are available
for other category members (see attached category justification).
The subchronic toxicity of the read-across substance was tested in
crossbred albino rats in a 90 -day feeding trial. Three groups
Sprague-Dawley rats (15/sex/dose) were administered the test article at
0 (group III), 10,000 (group II) and 50,000 ppm (group I) in the diet
(Hoechst AG, 1967). Control animals received plain diet. The following
parameters were evaluated: clinical signs, body weight, food
consumption, haematology, urinalysis, macroscopy and microscopy. The
following organs were examined histologically: heart, lung, liver,
kidney, adrenal glands, spleen, cerebrum, cerebellum, testes and
ovaries, pancreas, pituitary, thyroid gland, stomach and small
intestine. The general behaviour in groups I and II was normal
throughout the entire trial period and did not differ from that of the
control animals. None of the experimental animals showed signs of a
toxic effect. The test article was excreted via the feces. The food
consumption and the weight gains of the treated rats were normal and did
not differ from that of the control rats. The haematological
investigations revealed no pathological findings. Investigation of the
urine showed no pathological findings which could be attributed to the
test article administered. Macroscopic and microscopic examination
revealed no pathological organ damage. Based on the results of this
study, a NOAEL of 50,000 ppm for male and female rats was observed for
the test article.
Additionally, three subacute oral toxicity studies performed with other
members of the "Perylene" category are available (see attached CSR for
category justification). This information is also taken into
In a 28-day oral toxicity study with the read-across substance for that
endpoint was performed according to OECD guideline 407 and in
compliance with GLP. Sprague-Dawley rats (5/sex/dose) were administered
the test substance at 750, 3750 and 15000 ppm in the diet (Safepharm
Laboratories Ltd, 1990). These concentrations in the diet were equal to
79, 404 and 1573 mg/kg bw/day for males and 78, 380 and 1501 mg/kg
bw/day for females. The following parameters were evaluated: clinical
signs, body weight, food efficiency, water consumption and compound
intake, haematology, blood chemistry, urinalysis, organ weights and
histopathology. None of the animals died during the study. No clinically
observable signs of toxicity were noted in test or control animals
throughout the study. Bodyweight gain in all test animals was comparable
with that seen in controls. There were no treatment-related changes in
food consumption and food efficiency during the study. Anaemia was
demonstrated in females treated with 15000 ppm, but not in males from
the same dose group, identified by statistically significant reductions
in haemoglobin levels, erythrocyte counts and haemotrocrit. The anaemia
was very slight and apparently completely reversible since no such
changes were seen in satellite high dose females after fourteen days
without treatment. No toxicologically relevant changes were detected in
any of the urine parameters measured. No treatment-related differences
in organ weight were detected between test and control animals. All
morphological changes were those commonly observed in laboratory
maintained rats of the age and strain employed and, since there were no
differences in incidence or severity between control and treatment
groups, all were considered to be without toxicological significance.In
conclusion, a NOEL of 3750 ppm / 380 mg/kg bw/day for
females was established based on slight anaemia which was completely
reversible. The NOAEL was therefore set at the highest dose level, i.e.,
at 15000 ppm / 1573 mg/kg and 15000 ppm / 1501 mg/kg bw/day for male and
female rats, respectively.
Two more 28-day studies are available for two other substances
from the same category (Notox, 2006 and RTC, 2006). Both studies were
compliant with GLP and OECD guideline 407. In both studies, the test
article was administered to groups of 5 rats per sex and group at dose
levels of 100, 300 and 1000 mg/kg bw by gavage. Control animals were
treated with the vehicle alone. Five additional animals for each sex
were included in the high and control groups for recovery assessment
over a period of two consecutive weeks. The following parameters were
evaluated: clinical signs daily, functional observation tests, body
weight and food consumption weekly, clinical pathology at the end of
treatment, macroscopy at termination, organ weights and histopathology
on a selection of tissues. No toxicologically relevant changes were
observed in any of the parameters determined in these studies.
Consequently, a NOAEL of 1000 mg/kg body weight was established for both
Conclusion: Based on the available and reliable data obtained in long
term application studies with the test article and three category
members, no classification for repeated dose toxicity is warranted. The
established NOAELs for the tested substances were all above 1000 mg/kg.
Therefore, a NOAEL of 1000 mg/kg bod weight was also established for the
test article based on this read across/category approach.
Classification, Labeling, and Packaging Regulation (EC) No.
The available experimental test data are reliable and suitable for the
purpose of classification under Regulation (EC) No.1272/2008. Based on
the data, classification for repeated dose toxicity is not warranted
under Regulation (EC) No.1272/2008.
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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