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EC number: 417-790-1
CAS number: 78418-01-6
Combined LD50=3354 mg/kg bw by oral route.LD50>2000 mg/kg bw in a limit test by dermal route.
Table 2: mortality data in the main study
Table 3: Individual bodyweights in males
Dose level (mg/kg)
Body weight (g) on day :
Increment during week
Table 4: Individual bodyweights in females
In an acute oral toxicity study
performed in accordance with GLP and OECD guideline 401, groups (5/sex)
of Sprague Dawley rats were given a single oral dose of test material in
arachis oil at 2530, 3000, 3557, 4217 and 5000 mg/kg bw. Animals were
then observed for mortality, clinical signs and bodyweights for 14 days
and were all macroscopically necropsied after death or sacrifice. A
preliminary range-finding test was also conducted on 1 rat/sex/dose at
500, 1000, 3000 and 5000 mg/kg and animals were observed for 5 days. In
this previous test, no mortality was recorded.
Mortality occurred in the main study
at 3000 mg/kg and higher. Major signs of toxicity noted in all dose
groups were hunched posture, pilo-erection, lethargy, ptosis, decreased
or gasping respiration and red/brown staining around the snout or mouth.
Incidents of reduced bodyweight gain or bodyweight loss were noted in
all dose groups. Abnormalities noted at necropsy of animals that died
during the study were haemorrhagic or abnormally red lungs, dark liver
or patchy pallor of the liver, pale spleen, pale or dark kidneys,
haemorrhage or sloughing of the glandular gastric epithelium and
haemorrhage of the small and/or large intestines.
The combined oral LD50 was 3354 mg/kg
with 95% confidence limits between 2834 and 3970 mg/kg.
The oral LD50 for test material is
higher than 2000 mg/kg bw in rats therefore it is not classified
according to the Annex VI to the Directive 67/548/EEC and the CLP
ER 195 was tested for acute dermal toxicity
in Sprague-Dawley rats in a limit dose assay according to OECD guideline
402 in compliance with GLP. Groups of rats (5/sex) were administered a
single dermal dose of ER 195 at 2000 mg/kg bw on clipped skin moistened
with arachis oil using a semi-occlusive patch held in place for 24 h.
Skin was washed with a cotton wool moistened with arachis oil at the end
of the 24-hour exposure period. Examinations for mortality, clinical
signs and body weight gain were performed during a 14-day observation
period. All surviving animals were necropsied at the end of the
observation period. No deaths and clinical signs occurred during the
observation period. Body weight gain was not affected by treatment
(except for one male). At necropsy, macroscopic examination of main
organs showed no abnormalities. The acute dermal combined LD50 was
greater than 2000 mg/kg bw.
Adverse dermal reactions noted were oedema,
blanching and hard, light brown coloured scabs at the site of
application with loss of the upper layers of skin and fur resulting in
Under the test conditions, ER 195 should not
be classified according to the criteria of the Annex VI of the Directive
67/548/EEC and the CLP Regulation (EC)
In an acute oral toxicity study
performed in accordance with GLP and OECD guideline 401, the combined
oral LD50 was 3354 mg/kg bw with 95% confidence limits between 2834 and
3970 mg/kg bw.
In a limit dose assay performed according to
OECD guideline 402 in compliance with GLP, LD50 in Sprague-Dawley rats
was higher than 2000 mg/kg bw.
Oral and dermal LD50 are higher than 2000
mg/kg bw in rats therefore Mexoryl SAB does not need to be classified
for acute toxicity according
to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.
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