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CAS number: -
ACUTE ORAL TOXICITYThe study was performed according to OECD guideline No. 423 and EU method B.1tris in a GLP certified testing facility. The test was performed as limit test with a single oral dose of 2000 mg/kg bw of 400160. No effects were observed. The LD50 of 400160 is higher than 2000 mg/kg bw by oral route in the rat. ACUTE DERMAL TOXICITYThe acute dermal toxicity study with 400160 was performed according to OECD guideline 402 and EU method B.3 in a GLP certified testing facility. The test was performed as limit test with a single dose of 2000 mg/kg bw. No effects were observed. The LD50 of 400160 is higher than 2000 mg/kg bw by dermal route in the rat. ACUTE INHALATION TOXICITYThe acute inhalation toxicity test was waived as acute toxicity data is available for the oral and dermal route. Considering manufacturing and known uses the exposure by inhalation has not to be tested.
In an acute
oral toxicity study 2 groups of 8-week old female Sprague Dawley (SPF
Caw) (n=6) were given a single oral dose of 400160 at a dose of 2000
mg/kg b.w. and observed for 14 days.
mortality or any other clinical signs related to the administration of
the test item were observed. The body weight evolution of the animals
remained normal throughout the study. The microscopic examination of the
animals at the end of the study did not reveal treatment-related changes.
was performed as limit test.
(females) >2000 mg/kg b.w.
of low toxicity based on the LD50 in female rats.
dermal toxicity study of 400160 was performed as limit test. Groups of
young adult Sprague Dawley rats (5 male/5 female) were dermally exposed
to 400160 for 24 h to at least 10% of body surface area at a dose of
2000 mg/kg bw. Animals then were observed for 14 days.
mortality occurred during the study. No systemic clinical sign related
to the administration of the test item was observed. The body weight
evolution of the animals remained normal throughout the study. The
macroscopically examination of the animals at the end of the study did
not reveal treatment-related changes.
conclusion, the LD50 of 400160 is higher than 2000 mg/kg bw
by dermal route in the rat.
to REACH Annex VIII, section 8.5., column 2, acute toxicity data should
be presented for the oral route and at least for one additional route
(i.e. dermal or inhalative). The choice for this second route shall
depend on the nature of the substance and the likely route of human
inhalative route is not considered to be relevant for 400160, as the
vapour pressure of this compound is low (see section 4.6 of this IUCLID
dataset) and exposure to aerosols, particles, or droplets of an
inhalable size is unlikely. Moreover, the conditions used in the
manufacturing and formulation process of 400160 do not suggest a
significant exposure via air.
the acute toxicity data available for the oral and dermal route are
regarded as sufficient and performing and additional acute inhalative
toxicity study is not necessary.
the result of the oral toxicity study, it can be concluded that 400160
has a very low toxicity to rats after a single oral administration.
According to the current EU-CLP criteria, this compound cannot be
classified with respect to acute oral toxicity, as the LD50value
(>2000 mg/kg bw) exceed the range given for all three categories of the
EU-CLP system. No risk phrase is required.
the results of the dermal toxicity study (LD50 >2000 mg/kg
bw) it can be concluded that 400160 does not have to be classified
according to the criteria for classification, packaging and labelling of
dangerous substances and preparations in accordance with the E.E.C.
Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is
required. In accordance with the Regulation EC No. 1272/2008, the test
item does not have to be classified. No
signal word or hazard statement is required.
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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