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EC number: 701-281-9
CAS number: -
Table: Body weights and body weight
Individual data, mean and standard
Body weight (g)
Body weight gain (g)
Table: Observations in life.
Dose(mg / kg), sex
No. of the affected animals
Observation time(p.a.) first last
4 h - 6 h
test substance related stain of skin
1 d - 14 d
1 d - 12 d
1 d - 13 d
Table: Necropsy findings.
Dose(mg / kg)sex
No. of affectedanimals
no abnormal findings
11, 12, 13, 14, 15
16, 17, 18, 19, 20
No. of animals
Staining of the skin which is
attributed to the staining property of the test substance was observed
in all animals.
The aim of the study was to
investigate acute toxic effects of the test substance after a single
dermal administration to rats in conformance with the OECD Guideline
402, 1987 and the Council Regulation (EC) No 440/2008, Method
B.3. and in compliance with GLP criteria.
The test substance was
administered once topically on an area of approximately 6.5 cm x 8 cm on
the dorsal thoracic region of 5 male and 5 female Sprague Dawley rats. The
dose was 2000 mg per kg body weight. A cellulose patch with
the calculated amount of the test substance on the surface and soaked
with deionised water to get optimal contact with the skin, was applied
to the test site and held in place by fixing marginally with non
irritating tape. The test
site was covered by a semi-occlusive dressing. The duration
of the exposure was 24 hours. Body
weights were investigated before the administration, 7 and 14 days after
the administration (p.a.). Clinical observations were performed at least
once per day. All animals were sacrificed and necropsied 14 days p.a.
No local or systemic toxic effects
related to administration of the test substance were noted from clinical
observations or post-mortem-examination at a dose of 2000 mg of the test
substance per kg body weight.
No mortality occurred. All
animals but one male did not show any clinical signs during the entire
Chromodacryorrhoea was noted in one male
from 4 h until 6 h p.a. This might be due to the discomfort, caused by
the dressing and was not considered to be toxicologically relevant. A
yellow staining of the skin was observed in all animals from 1 d until a
maximum of 14 d p.a. This stain is attributed to a staining property of
the test substance and not considered to be a toxic effect. No other
alterations to the exposed skin by the test substance were found. All
animals gained weight in both weeks p.a., all animals recovered fully.
The LD50 dermal was concluded to be > 2000 mg/kg bw.
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