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EC number: 942-523-5
CAS number: -
Oral LD50 > 500 mg/kg bw and < 2000 mg/kg bw
Dermal LD50>2000 mg/kg bw
an Acute Toxic Class Method study
performed according to OECD 423 under GLP conditions, the
acute oral toxicity to rats was assessed (Bioassay,
2017). A group
of three fasted female Wistar rats were exposed to the test substance at
a dose of 2000 mg/kg bw by gavage in one administration as a first step.
In the second step, two groups of three fasted female Wistar rats were
exposed to the test substance at a dose of 500 mg/kg bw. The first group
received the dose in one administration, the second in two
administrations. After an observation period of 14 days animals were
necropsied. In the 2000 mg/kg bw group, the following clinical signs
were recorded: mortality in all animals, impaired general state in all
animals, dyspnoea in all animals, piloerection in all animals and
cowering position in all animals. In the two 500 mg/kg bw groups, no
mortality occured. The following clinical signs were recorded: impaired
general state in all animals, piloerection in all animals and dyspnea in
one animal. Body weigths were normal and no macroscopic pathological
findings were observed in the surviving animals. The LD50 was determined
to be >500 mg/kg bw and < 2000 mg/kg bw.
In an acute dermal toxicity study (Limit
Test), young adult Wistar rats (5 males and 5 females) were dermally
exposed to a single dose of 2000 mg/kg bw of Fatty acids, C12-14,
a-sulfo, disodium salts (as suspension in deionized water) (Bioassay, 2017).
The clipped application site (dorsal and dorso-lateral parts of the
trunk, comprising at least 10% of the total body surface) was covered by
semi-occlusive dressing during the 24-hour exposure period. The animals
were observed for 14 days.
Neither mortality nor signs of systemic
toxicity were observed in the animals.
The following test item-related local
effects were recorded during the course of the study, local effects
occurred within 14 days after application:
Very slight to well-defined erythema
(grade 1 to 2)
Very slight edema (grade 1)
Eczema like skin lesions
Weeping areas of the skin
No macroscopic pathologic abnormalities
were noted in any animal examined at the end of the study.
The body weight of the male animals
increased within the normal range throughout the study period. The
female animals showed stagnation of body weight in two animals, while in
the other three animals a marginal loss of body weight was observed
during the first week. Two female animals gained weight in a normal
range during the second week, while the other three animals showed
stagnation of body weight during the second week. Due to the fact, that
stagnation or slight loss of body weight is commonly known for females
after dermal applications, this stagnation is considered to be
No mortality occurred. Accordingly, the
acute dermal median lethal dose (LD50) was determined to be LD50,
dermal, rat > 2000 mg/kg bw
Based on the available
data, the substance has to be classified as Acute Tox. 4; H302: 'Harmful
if swallowed' according to EU
Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Regulation (EC) No. 1272/2008
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