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EC number: 221-264-5
CAS number: 3049-71-6
LD50 oral in rats >5000 mg/kg bw
LC50 inhalation in rats > 5400 mg/m³
LD50 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 performed
with the test article, groups of rats (5/sex/dose) were administered the
test substance at single doses of 200, 1600, or 6400 mg/kg bw by gavage
followed by a 14-day observation period (BASF, 1966). None of the
animals died during the exposure period. Animals displayed clinical
signs such as sedation, ruffled fur, dyspnea, curved body position, and
red colored feces. No abnormal findings were made at necropsy. The LD50
was > 6,400 mg/kg bw.
In another acute oral toxicity study comparable to OECD guideline 401,
Sprague-Dawley rats (5/sex/dose) were administered the test substance at
a single dose of 5,000 mg/kg bw by gavage followed by a 7-day
observation period (BASF, 1978). None of the animals died during the
exposure period. Animals did not display any clinical signs, except red
stained feces. No abnormal findings were made at necropsy. The LD50 was
>5,000 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 5,000 mg/kg.
Regarding inhalation, only unreliable data is available for the test
article. Two inhalation risk tests (BASF XXII/87, 1972 and BASF XXV/564,
1976), which demonstrate the toxicity of an atmosphere saturated with
vapors of the volatile components, were performed with the test article.
The nominal concentration is calculated as quotient of the amount of the
test substance weight loss during exposure. In the first test, two
groups of rats (3/sex/group) were exposed sequentially to the dusts for
8 h. None of the animals died during the exposure period and no abnormal
clinical signs were reported. Body weights and gross pathology were
normal. The concentration of the test article in the atmosphere could
not be determined. In the second inhalation risk test two groups of rats
(3/sex/group) rats were exposed to a dust atmosphere for 8 hours. No
deaths were reported and no signs regarding body weights and gross
pathology were reported. Distinct irritation of the mucous membrane was
observed. Average concentration of substance in the atmosphere as stated
in the report was 2.43 mg/l. However, since this test design is
insufficient for non-volatile substances, these tests are disregarded.
Several other inhalation risk tests were performed for other category
members, they were disregarded as well.
Reliable data is available for four other category members. Three
substances were tested in OECD 403 guideline tests and a fourth
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 procedure. 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).
One of these category members was chosen to cover the endpoint
conducting a read-across entry, namely CAS 4948 -15 -6. The acute
toxicity inhalation test was performed according to OECD 403 (limit
test) not in compliance with GLP. The concentration used was 5.2 mg/l
and five rats per sex were exposed to the dust of the test substance via
inhalation. After an observation period of 14 -days, no animal was found
dead. Clinical signs observed were 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 animals. No pathologic findings were noted. LC50
was concluded to be greater than 5.2 mg/l (BASF, 1989).
Conclusion: Based on the data obtained with members of the “Perylene
based pigments” category, no classification for acute toxicity is
required. The data obtained with the category members is used to define
an LC50 value in rats for the test article after inhalation of above
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.
Justification for selection of acute toxicity – dermal endpoint
Acceptable, well-documented study report
Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental
test data are reliable and suitable for classification purposes under
Regulation 1272/2008. As a result the substance is not considered to be
classified for acute toxicity 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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