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EC number: 225-590-9
CAS number: 4948-15-6
LD50 oral in rats > 5000 mg/kg bwLC50 inhalation in rats > 5200 mg/m³LD50 dermal in rats > 2500 mg/kg
Results of analytical measurements:
Particle size analysis:
The MMAD 50% = 3.0 µm (geometrical standard deviation =3.6) was
calculated from the results of the particle size analysis.
A respirable dust aerosol fraction that might reach the alveolar region
of 82% was obtained from the results of the particle size analysis.
The test article belongs to the "perylene based organic pigments"
category (see attached document for details on category members and for
read across justification). According to the category approach, missing
toxicity endpoints can be addressed with data available for other
category members. Regarding acute toxicity, reliable data are available
for the test article and for other members of the "Perylene based
pigments category". All of these data are taken into account for the
evaluation and assessment of the acute toxicity of the test article.
In an oral toxicity study comparable to OECD guideline 401, ten
female albino rats were treated with the test article at
15,000 mg/kg bw by single oral dose (gavage) followed by a 7-day
observation period (Hoechst AG, 1967). None of the animals died during
the exposure period. No abnormal clinical observations were observed;
the pigment was excreted via the feces. The LD50 in this study was >
15000 mg/kg bw.
In another study comparable to OECD guideline 401, female Wistar
rats (n=10) were treated with the test article at 5000 mg/kg bw by
single oral dose (gavage) followed by a 14-day observation period
(Hoechst AG, 1982). None of the animals died during the exposure period.
No abnormal clinical observations were observed; the pigment was
excreted via the feces. A normal weight gain was observed and no
abnormal findings were made at necropsy. Based on the results of this
study, the LD50 was determined to be greater than 5000 mg/kg bw.
In several studies performed with other substances from the Perylene
category the potential for oral toxicity was found to be very low. None
of these studies raised any concerns regarding acute toxicity after oral
application and therefore none of the substances requires
classification. The LD50 values observed for these compounds ranged from
5,000 to 15,000 mg/kg body weight (maximum doses).
Conclusion: Based on the available data for the test substance and
taking the data of category members into account, no classification for
acute toxicity is warranted. The LD50 after oral administration in rats
was determined to be greater than 10,000 mg/kg.
In an inhalation toxicity study according to OECD guideline 403,
Wistar rats (5/sex) were exposed to the test article as dust for 4 hours
at a measured concentration of 5.2 mg/L followed by a 14-day observation
period (BASF AG, 1989). Cascade impactor measurements resulted in a
particle size distribution with a mass median aerodynamic diameter
(MMAD) of 3 µm (GSD: 3.6), which is well within the respirable range.
None of the animals died during the study period. Clinical signs
included irregular, accelerated and/or intermittent respiration, flight
behaviour and discoloured fur. From day 7 of the observation period
onward, no abnormalities, except discoloured fur, were detected in the
animals. The body weight gain of male and female rats in the test group,
compared with a historical control collective, was not affected by the
substance over the total observation period. No pathologic findings were
noted during gross pathology. The LC50 was >5.2 mg/L.
Two other category members were tested in OECD 403 guideline tests and a
third substance was tested in a study similar to guideline 403. In all
studies rats were exposed to dust aerosols analytically verified for a
duration of 4 hours. Except for one study with a single case of
mortality all animals survived the procedures. The observed clinical
signs included accelerated respiration, pulmonary respiration sounds,
squatting posture, piloerection, flight behavior and smeared fur. No
pathological abnormalities of the organs were observed at termination in
all animals in any of the studies. The analytically determined
concentration of the test articles was greater than 5.1 mg/l in all of
the studies (5.1 - 5.4 mg/l). Therefore, all studies resulted in an LC50
value of greater than 5.1 mg/l.
Conclusion: Based on the data obtained with the test article and taking
the results of tests performed with other members of the Perylene
category into account, no classification for acute toxicity is required.
No data regarding acute toxicity after dermal exposure is available for
the test substance. However, two studies performed with a category
member are available. In the key study comparable to OECD guideline 402,
5 Sprague-Dawley rats of each sex were treated with the test substance
at 2500 mg/kg bw by single dose followed by a 14-day observation period
(BASF AG, 1976). None of the animals died during the exposure period. No
abnormal clinical observations were observed and no abnormal findings
were reported during necropsy. The LD50 was >2500 mg/kg bw.
In a supporting dermal toxicity study comparable to OECD guideline 402,
Sprague-Dawley rats (5/sex) were administered a mixture containing 18.5%
of the test substance at 5 ml/kg bw by single dose followed by a 14-day
observation period (BASF, 1976). None of the animals died during the
exposure period. No abnormal clinical observations were observed and no
abnormal findings were reported at necropsy.
Conclusion: Based on the available data no classification for the test
substance regarding dermal toxicity is warranted. The result obtained
with the category member is used to set the dermal LD50 of the test
substance at 2500 mg/kg bw.
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 acute 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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