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EC number: 227-876-9
CAS number: 6021-61-0
Oral LD50 (male and female) > 5350 mg/kg bw
Mortality ratio and group mean bodyweight
(g) of rats
Test item was dissolved in DMSO; the test
sample was prepared immediately before dosing. A preliminary study was
carried out to establish a dosing regimen, using groups of two males and
two females at two dosage, using 10-15 ml/kg body weight. In the main
experiment, groups of five male and five female rats were dosed at
levels selected using the results of the preliminary study. The animals
were dosed by oral gavage by means of a stomach tube and the dosed
volume was 15 ml per kg body weight. The animals on both, the
preliminary and the main studies were observed for 14 days after dosing.
Surviving animals were killed after two
weeks. All animals which died during the study and those killed after
two weeks were subjected to a macroscopic postmortem examination. The
macroscopic appearance of the abnormal organs was recorded.
One female died 59 hours after dosing. No
overt symptoms of poisoning were observed. No special findings could be
LD50 > 5350 mg/kg bw (males and females)
ACUTE ORAL TOXICITY
A study was performed to assess the acute
oral toxicity of the test material in the young adult male and female
Han-wistar strain rat. Test item was dissolved in DMSO. A preliminary
study was carried out to establish a dosing regimen, using groups of two
males and two females at two dosage, using 10-15 ml/kg body weight. In
the main experiment, the animals were dosed with 5350 mg/kg bw, by oral
gavage. One female died 59 hours after dosing; no overt symptoms of
poisoning were observed and no special findings could be detected.
A second experiment conducted on Direct
Red 054 is available; however, it was performed using a sample with a
limited content of test item, thus, it is here reported just as a
The test item was suspended in 40 %
aqueous gun tragacanth (0.5 %) and given to a group of five male and
five female rats; in addition, five males and five females were treated
with vehicle only and served as control. The animals were dosed at 5000
mg/kg bw by oral intubation.
One female rat died within 43 hours of
treatment; the autopsy did not reveal any specific cause of death. Signs
of reaction to treatment, observed shortly after treatment consisted of
lethargy, piloerection and moderate diuresis. The urine and fur of all
rats was stained red. Recovery of survivors, as judged by external
appearance and behaviour, was apparently complete within four days of
treatment. Slightly depressed bodyweight gains were observed in female
rats during the first week of the observation period, but returned to
normal during the second week of observation, compared with controls.
Terminal autopsy findings were normal in all rats.
ACUTE INHALATION TOXICITY
No acute toxicity studies by inhalation
route are available on Disperse Red 054. Nevertheless, because of the
physical state of the substance inhalation is not an appropriate route
of exposure. The vapour pressure of the substance is estimated to be
negligible; the particle size distribution showed that the 98.2 % of
particles have a diameter higher than 45 µm; thus, Disperse Red 054 is
characterized by particles not-respirable. This consideration, together
with the consideration that the substance is manufactured and handled
with suitable risk management measures and with the suitable personal
protective equipments, lets to consider the possible absorption of the
substance by inhalation route as negligible.
ACUTE DERMAL TOXICITY
No acute toxicity studies by dermal route
are available on Disperse Red 054. Nevertheless, the possible absorption
rate of the substance by dermal route is not expected to be significant.
In the Commission Regulation (EU)
2016/863, amending Annexes VII and VIII to REACH Regulation (EC 1907/2006),
it is explained that recent scientific analysis of available data from in
vivo acute toxicity studies have shown that substances that are not
toxic via the oral route may be expected with high certainty to be also
non-toxic via the dermal route. Therefore, testing those substances via
the dermal route does not provide essential information for their safety
assessment. The amendment is the consequence of studies and scientific
debates. In particular, the 15th
Meeting of Competent Authorities for REACH and CLP (CARACAL, 2014)
concluded that the avoidance of a dermal route test is justified for
substances that have shown no toxicity in acute oral toxicity test up to
the limit dose of 2000 mg/kg bw.
Since during the oral acute toxicity tests
no signs of systemic toxicity were recorded, the substance is not
expected to be harmful/toxic by dermal route.
According to the CLP Regulation (EC
1272/2008), 3.1 Acute toxicity section, substances can be allocated to
one of four toxicity categories based on acute toxicity by the oral,
dermal or inhalation route according to the numeric criteria. Acute
toxicity values are expressed as (approximate) LD50 (oral, dermal) or
LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be
greater than 5000 mg/kg bw, therefore the test substance is out of any
classification limit for acute oral toxicity (oral acute toxicity
category 4: 300 < ATE ≤ 2000 mg/kg bw).
In conclusion, the test substance does not
meet the criteria to be classified for oral acute toxicity, according to
the CLP Regulation (EC 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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