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EC number: 242-893-1
CAS number: 19223-55-3
LD50 (rat, oral) = 3020 (females) or 2950 (genders combined) mg/kg bwLD50 (rat, dermal) > 2000 mg/kg(expressed as mg active ingredient)
Dose level (mg/kg)
(Day 0 = day of administration)
Bodyweight at necropsy
Bodyweight measurements (in grams, main study)
hydroxysultaine, as a 41.5% solution, has been tested for acute oral
toxicity in Wistar rats. The test article was administered as a single
oral dose by gavage. One group of 5 rats per sex received a dose of 2000
mg test solution/kg bw. Examinations for mortality and clinical signs
were performed daily during the 14 -day study period. Animals
were necropsied at the end of the observation period.
No mortality was observed. Slightly soft feces were noted among treated
animals on the day of dosing, but no other clinical signs were observed
over the rest of the observation period. Bodyweight was not affected by
the administration. No relevant changes were seen at necropsy.
The oral LD50 in rats was therefore higher than 2000 mg test solution/kg
bw, equivalent to approximately 830 mg active ingredient/kg bw.
Cumulative Mortality over the 14-day observation period
hydroxysultaine, as a 42% aqueous solution, has been tested for acute
oral toxicity in Wistar rats. The test article was administered as such
using different dosing volumes to reach the desired dose levels. Three
groups of 5 rats per gender received a dose volume of 2.33, 4.65 and
6.98 mL/kg, equivalent to 1000, 2000 and 3000 mg active ingredient/kg,
respectively. Examinations for mortality and clinical signs were
performed daily during the 14-day study period. Body weights were
measured just before dosing, and 7 and 14 after dosing. A macroscopic
examination was performed at the necropsy of survivors on day 14.
A high incidence of pre-terminal deaths occurred at 2000 and 3000 mg/kg,
whereas no death occurred at 1000 mg/kg: 3/5 male rats were found dead
or sacrificed in extremis within 24 hours of dosing in the 3000 mg/kg
dose group, and 2/5 female rats were found dead or sacrificed in
extremis within 24 hours of dosing in each of the 2000 mg/kg and 3000
mg/kg dose groups. Marked clinical signs, such as general reduced
activity together with diarrhea, squatting position, piloerection and/or
reduced skin turgor were observed at 3000 mg/kg within 3 days
post-dosing. Body weight gain was normal in surviving animals over the
observation period. Hemorrhagic and lytic mucous membrane alterations in
the gastro-intestinal tract, considered test-article related, were
observed at necropsy in animals found dead or sacrificed in extremis
within 24 hours of dosing in the 2000 mg/kg and 3000 mg/kg dose groups.
At terminal sacrifice, no test-related macroscopic findings were
observed in the other animals.
The oral LD50 in rats was calculated to be 3020 or 2950 mg active
ingredient/kg bw, for females or both genders, respectively, at 24 hours
and 14 days after administration. The oral LD50 in male rats could not
be calculated because deaths occurred only in the high-dose group.
Mean bodyweight gains (grams) during the observation period
hydroxysultaine, as a 36.2% solution (Mackam CBS-50GE), has been tested
for acute dermal toxicity in Sprague-Dawley rats. The test article was
applied as a single dose under a semi-occlusive dressing for 24 hours.
One group of 5 rats per sex received a dose of 2000 mg active
ingredient/kg bw. Examinations for mortality and clinical signs were
performed daily during the 14 -day study period. Animals were
necropsied at the end of the observation period.
No mortality was observed. No clinical signs indicative of systemic
toxicity were observed. Very slight or well defined erythema was noted
at the application site for 2 females on day 2. Mean bodyweight gain was
slightly lower than historical control data for females over the
observation period, notably during the first week following application.
However, no such changes were observed for males. Enlargement of the
spleen was found in all treated animals but was considered incidental as
it is part of the normal background in untreated rats of these strain
The dermal LD50 in rats was therefore higher than 2000 mg active
In the absence of studies conducted according to OECD guidelines,
a read-across was therefore performed with the cocamidopropyl
hydroxysultaine which contains alkylamidopropylhydroxysultaine with
carbon chain from C8 to C18. The main component of
Cocamidopropylhydroxysultaine C8-18 is lauramidopropylhydroxysultaine.
Justification for the read-across is documented in a separate document
attached in Iuclid Section 13.
Based on the nature of the substance and its likely routes of
exposure, the acute toxicity of Cocamidopropyl hydroxysultaine has been
tested by oral and dermal routes.
Two Klimisch score 2 studies in rat were available for oral route.
One study was used as a key study and the other two as supporting:
One Klimisch score 1 study was available for dermal route and was
used as a key study. In this study (2012), Cocamidopropyl
hydroxysultaine was applied for 24 hours under semi-occlusive coverage
at the dose of 2000 mg active ingredient/kg as a 36.2% active ingredient
aqueous solution to 5 rats per gender, kept for a 14-day observation
period and then necropsied. No mortality, overt sign of toxicity, or
relevant bodyweight changes were observed. Therefore, the LD50 was
higher than 2000 mg active ingredient/kg. Based on the absence of
mortality or severe clinical signs in rats up to 2000 mg active
ingredient/kg, no classification for dermal acute toxicity is warranted.
No target organ was identified following a single dermal application in
Justification for selection of acute toxicity – oral endpoint
Study with the highest degree of compliance with presently
recommended test standards.
Justification for selection of acute toxicity – dermal endpoint
Only one study available
on the LD50 values obtained in the key study performed on the analogue substance
Cocamidopropyl hydroxysultaine, no classification for oral acute
toxicity is warranted according to Reg. (EC) No 1272/2008 (CLP)
criteria. This is supported by the absence of mortality or severe
clinical signs in rats up to 830 mg active ingredient/kg seen in the
other study under consideration.
In accordance with CLP Regulation (EC) No 1272/2008 criteria, as
the dermal LD50 in rats is higher than 2000 mg active ingredient/kg, no
classification for dermal acute toxicity is warranted.
No target organ was identified following a single oral or dermal
administration in rats.
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