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EC number: 201-174-2
CAS number: 79-07-2
Skin irritation of Chloroacetamide was tested in vivo in a key irritation study in rabbits, resulting in mean scores of 1.1 and 0.5 for erythema and edema, and some additional changes that were reversible within 7 days. Eye irritation was tested in vivo in a key irritation study in rabbits, resulting in mean scores 1.7, 1.0, 2.9 and 3.0 for cornea, iris, conjunctival redness and chemosis, respectively, and additional changes that were all revesible within 21 days. Based on these data, Category 2 classification for eye irritation was warranted.
Table 1. Results
Erythema (time after decontamination)
OVERALL MEAN ERYTHEMA (24, 48, 72h): 1.1
Edema (time after decontamination)
OVERALL MEAN EDEMA (24, 48. 72h): 0.5
A dorsal area of the trunk of approximately 25 cm2
of 3 rabbits was shaved ca. 24 hours before the start of the test
. Each animal (intact skin) was applied with 500 mg Chloroacetamide
(made into a paste with 0.25 mL of 0.9% NaCl solution). The mixed
substance was applied on a wound plaster with 2.5 X 2.5 cm cellulose pad
and the plaster strips were attached to the prepared skin site under a
semiocclusive bandage. After 4 hours exposure, the remaining test
substance was washed carefully with lukewarm tap water. Observations
were done at 30-60 minutes and at 24, 48 and 72 hours after removal of
the plaster. As there were some other findings in 1 animal (skin suface:
coarse scales, dry, rough), additional observation was done up to 7
days. All changes were reversible within 7 days. Althoug Chloroacetamide
was assessed as slightly irritating, there is no reason for
The Skin irritation test in rabbits has shown that
Chloroacetamide according to the present study is assessed as slightly
Table 1. Individual readings
In 3 rabbits, 100 mg chloroacetamide
was applied in the conjunctival sac of the left eye. The
untreated eye served as control. The assessments of the eyes
were made at 1, 24, 48 and 72 hours after application of
test substance. At the evaluation time points 24 and 72
hours after application the cornea was additionally examined
for damage after instillation of fluorescein-sodium
solution. Mean scores for cornea, iris, conjunctival redness
and chemosis were 1.7, 1.0, 2.9 and 3.0, respectively. As
there were still effects on the eyes at 72 hours, an
additional observation was done at 7, 14 and 21 days.
In a key primary skin
irritation study (Hoechst, 1993a) in 3 New
Zealand White rabbits, 500 mg Chloroacetamide
(made into a paste with 0.25 mL 0.9% saline
solution) was applied to the intact skin for 4
hours under semiocclusive bandage. Mean scores
were 1.1 for erythema/eschar formation and 0.5
for edema, with individual scores varying
between 0.3 -2 and 0-1.3, respectively. As there
were some other findings in 1 animal (skin
surface: coarse scales, dry, rough), additional
observation was done up to 7 days. All changes
were reversible within 7 days. Although the
substance was reported as slightly irritating,
there is no reason for classification. In a
supporting study (Hoechst, 1958) no signs of
irritation of Chloracetamide were observed at
the depilated flank skin of rabbits at
concentrations up to 10%. In another supporting
study with a low concentration (5%) of a
different formulation (70% active ingredient;
30% sodium benzoate), primary irritation index
was 0.2 (IBR, 1981a).
In a key eye irritation
study of 3 New Zealand White rabbits (Hoechst,
1993b), 100 mg Chloroacetamide was applied in
the conjunctival sac of the left eye. The
untreated eye served as control. The assessments
of the eyes were made at 1, 24, 48 and 72 hours
after application and rinsing of test substance.
After 1 to 7 hours the animals displayed severe
reddening and swelling of the conjunctivae. In
addition, corneal clouding was seen. As there
were still effects at 72 hours, additional
observations were done at 7, 14 and 21 days.
Mean scores for cornea, iris, conjunctival
redness and chemosis were 1.7, 1.0, 2.9 and 3.0,
respectively. Additional changes observed were
all reversible within 21 days. Based on this,
Chloroacetamide was evaluated as irritant for
the eye. In a supporting study (Hoechst, 1958)
no signs of irritation were observed at the eyes
of rabbits at concentrations up to 10%. In
another supporting study in rabbits with a low
concentration (5%) of a different formulation
(70% active ingredient; 30% sodium benzoate),
primary irritation index was 0.7 (IBR, 1981b).
Based on these results and according to the EC Directive
(No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008),
Chloroacetamide does not have to be classified and has no obligatory
labelling requirement for skin irritation.
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