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EC number: 220-688-8
CAS number: 2867-47-2
No mortality occurred in a well-conducted
GLP guideline study (OECD TG 401) at the dose level of 2000 mg/kg.
Therefore, the acute oral LD50 of this substance is
considered to be higher than 2000 mg/kg bw.
No mortality occurred in a well-conducted GLP guideline study (OECD TG
402) at the dose level of 2000 mg/kg. Therefore, the acute dermal LD50
of this substance is
considered to be higher than 2000 mg/kg bw.
According to a report on the acute 4-hour inhalation toxicity in rats
the acute inhalation LC50 of this substance is considered to be 620
mg/m³. The reliability of this value
is not assignable since no sufficiently
detailed data were available for assessment.
A single oral toxicity study revealed a LD50 value of above 2000 mg/kg
bw for the substance in both sexes.
Acute oral toxicity in rats:
No. of males/females
Decrease in food consumption
(%, group mean)
Decrease in body weight gain
* calculated from original data using density of 0.933 g/cm³; m = males,
f = females, d = day
The acute oral LD50 in rats was calculataed to be 2612 mg/kg bw based on
the results obtained in female rats. The LD50 in female rats is slightly
lower than in male rats.
Laut OECD SIDS: LD50 ist 2656 mg/kg bw (beide Geschlechter)
The LD50 of the test substance administered by dermal route in rats is
higher than 2000 mg/kg.
There were various studies on the acute toxicity of the test substance
by different administration routes. In total, eleven reports on the
acute toxicity via oral, dermal, inhalation or intraperitoneal routes to
rats, mice or rabbits were reviewed.
Oral exposure route:
As for oral toxicity, the study by the Ministry for Health and Welfare,
Japan (MHW Japan, 1998) was considered to be the most reliable because
it was well conducted according to OECD TG 401 in compliance with GLP
and was therefore identified as the key study. In this study, SD rats
(5/sex/dose) were administered doses of 0 (vehicle), 500, 1000, 2000
mg/kg bw by gavage. Although raised patches and papillomatous
hyperplasia in die forestomach were observed, no death occurred in the
2000 mg/kg bw dose group. The LD50 after oral application is considered
to be greater than 2000 mg/kg bw. This result is supported by an acute
oral toxicity study in rats from Roehm, where an LD50 of 2659 mg/kg was
determined (Roehm, 1978).
Two other acute oral LD50 values in rats were reported to be equal
to 1550 mg/kg bw (Kirk-Othmer, 1978 -1984) or greater than 1751 mg/kg bw
(Izmerov, 1982). The reliability of these two studies is not assignable.
Dermal exposure route:
As for dermal toxicity, the study on rats by Atochem was identified as
the key study (Atochem, 1992). This study was conducted in accordance
with OECD TG 402 in compliance with GLP. At 2000 mg/kg dose in rats, no
mortality was observed although symptoms of hypokinesia, sedation,
dyspnoea and skin irritation were observed. The dermal acute lethal dose
is considered to be greater than 2000 mg/kg bw.
Inhalation exposure route:
Due to low vapour pressure (0.58 hPa at 20°C) and the exclusion of spray
applications, inhalation is not a relevant pathway of exposure.
Regarding acute toxicity by inhalation, a LC50 of 0.62 mg/L (620 mg/m³)
after a 4-hour inhalation of the test substance in rats and a LC50 of
1.8 mg/L (1800 mg/m³) after a 2-hour inhalation of the test substance in
mice were reported (Izmerov, 1982). However, the reliability of these
values is not assignable since no sufficiently detailed data were
available for assessment.
Other exposure routes (intraperitoneal):
As to the acute toxicity by intraperitoneal (i.p.) administration, LC50
values ranging from 25 mg/kg bw to 310 mg/kg bw were reported in three
studies with rats or mice (Kirk-Othmer, 1978 -1984; Paulet, 1975; NTIS,
1986). The severest value for the intraperitoneal acute toxicity was 25
mg/kg bw for mice (NTIS, 1986).
In the key study for acute oral toxicity the LD50 of the test substance
was determined to be higher than 2000 mg/kg (MHW Japan, 1998). Based on
these data, no classification of the test substance is required. There
are no reliable data considering acute inhalation toxicity. Based
on the data from acute dermal toxicity studies no classification of the
test substance is required. Accordingly, the following classification of
the test substance concerning acute toxicity is proposed:
GHS classification according to Annex I 1272/2008 CLP (EU GHS):
- Oral route: No classification
- Dermal route: No classification.
- Inhalation route: No classification.
However, the test substance is listed in Annex I of the Directive
67/548/EEC and in Annex VI of CLP regulation 1272/2008 (EU-GHS).
Accordingly, in spite of the contradictory database, the test substance
has to be classified as follows:
GHS classification according to Annex VI 1272/2008 CLP (EU GHS):
- Oral route: Acute toxicity - Cat. 4*
- Dermal route: Acute toxicity - Cat. 4*
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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