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EC number: 251-156-3
CAS number: 32687-78-8
The test article is virtually non-toxic after a single ingestion with an
oral LD50 of greater than 7000 mg/kg body weight. The substance appears
also not toxic after short-term inhalation.
Table 1: Mean body weight of male and female rats [g] at day 1, 7, and
Mean body weight [g] ± sd
4000 mg/kg bw
5000 mg/kg bw
6000 mg/kg bw
7000 mg/kg bw
Day 1 male
Day 1 female
Day 7 male
Day 7 female
Day 14 male
Day 14 female
In an acute oral toxicity study five male and five female Tif: RAIf
(SPF) rats were treated with test substance in PEG at dose levels of
4000, 5000, 6000, and 7000 mg/kg by gavage. Within the observation
period of 14 days dyspnoea, exophthalmus, ruffled fur, diarrhoea, and
curved body position have been observed, which were reversible within
the observation period. No mortality occurred. No substance related
gross organ changes were seen. Based on the results of this study, an
LD50 of > 7000 mg/kg bodyweight was derived.
Acute oral toxicity
Two reliable studies assessing the acute oral toxicity of the test
article are available. In the key study, five Tif: RAIf (SPF) rats/sex
and dose level were treated with the test substance in PEG 400 at dose
levels of 4000, 5000, 6000, and 7000 mg/kg body weight by gavage. Within
the observation period of 14 days dyspnoea, exophthalmus, ruffled fur,
diarrhoea, and curved body position have been observed, which were
reversible within the observation period. No mortality occurred and no
substance-related gross organ changes have been observed. Based on the
results of this study, an LD50 of > 7000 mg/kg bw was derived.
This finding was supported in a second study conducted with groups of
five Chinese hamsters per sex following OECD guideline 401. The test
article in arachis oil was administered at dose levels of 2500 and 5000
mg/kg body weight. Within the observation period of 14 days sedation,
dyspnoea, exophthalmus, ruffled fur, diarrhoea, and curved body position
have been observed, which were reversible within the observation period.
One male and one female hamster of the high dose group died at day 4
after administration of test substance. Based on the results of this
study, an LD50 of > 5000 mg/kg bodyweight was determined, further
demonstrating the low acute toxicity of the test article after
ingestion. A third study is available which was performed by a contract
research institute that was discredited for manipulating data and
falsifying study reports. Therefore, the reliability of the available
study is uncertain. However, the data presented in this report is in
line with the reliable reports and provides additional support of the
very low acute oral toxicity of the test article.
Acute dermal toxicity
No data available. But since the test article has a molecular weight of
> 500 and the log Pow is not within -1 to 4, a skin penetration of 10%
can be assumed and in light of the oral acute toxicity studies, the
substance is considered not toxic after single dermal application.
Acute inhalation toxicity
One study report is available which was performed by a contract research
institute discredited for manipulating data and falsifying study
reports. Therefore, the reliability of the available study is uncertain.
In this study, groups of rats were exposed to an atmosphere containing
the test article at 0.11 mg/l for 4 hours. Non of the animals died,
showing that the test article is of low acute toxicity. Since these
results are in line with the results of the oral studies also showing
very low acute toxicity, they are taken into consideration in a weight
of evidence 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, the test substance is not classified for acute toxicity.
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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