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EC number: 242-893-1
CAS number: 19223-55-3
The available experimental data in animals obtained on the analogue substance Cocamidopropylhydroxysultaine C8-18 [CAS 68139-30-0 or CAS 70851-08-0] show evidence of oral absorption and systemic distribution of the test substance and/or its metabolites or degradation products since treatment-related effects were reported in the kidneys following repeated oral exposure in rodents. No systemic effects were observed when the test substance was dermally applied in the acute dermal toxicity study. No specific indication on the test substance metabolism or excretion was obtained from the toxicity studies.
No specific toxicokinetic studies are
available on Lauramidopropyl hydroxysultaine. A toxicokinetic assessment
was made based on the physico-chemical properties of the test substance
and the results of toxicity studies (acute oral and dermal toxicity,
skin irritation, skin sensitisation, in vitro genotoxicity and repeat
dose toxicity studies) obtained on the analogue substances
cocamidopropylhydroxysultaines which contain
alkylamidopropylhydroxysultaine with carbon chain from C8/C12 to C18.
The main component of Cocamidopropylhydroxysultaine is
lauramidopropylhydroxysultaine. Justification for the read-across is
documented in a separate document attached in Iuclid Section 13.
Water solubility: 556 g/L (at 20°C)
Partition coefficient in octanol/water: 2.1
Vapour pressure: 2.3*10-8Pa (at 25°C)
Boiling point: 311.6 (at 101 kPa)
Density: 1.304 (at 20°C)
No data are
available for inhalation route of exposure. However, the test substance
is a liquid with a very low volatility, as evidenced by the low vapour
pressure and the elevated boiling point. Therefore it can be considered
that the absorption resulting from potential exposure by
the inhalation route
obtained in the repeated oral dose toxicity study (OECD 422 and OECD
408) confirmed the oral absorption of cocamidopropyl hydroxysultaine as
histopathological changes in internal organs such as kidneys were
observed, indicative of effects of cocamidopropyl hydroxysultaine and/or
its metabolites or degradation products distant from the site of
no evidence of systemic toxicity in the acute dermal toxicity study in
rats at the dose of 2000 mg/kg bw with C8 -18 cocoamidopropyl
hydroxysultaine. There were neither any signs of toxicity or
sensitisation after intradermal injection and topical challenge in a
guinea pig maximisation test with the analogue substance. In a human
repeated insult patch test performed with the registered substance
diluted at 12%, no signs of skin sensitisation were observed.
to the Guidance on information requirements and chemical safety
assessment (Chapter R.7c: Endpoint specific guidance), Log P values
between 1 and 4 favour dermal absorption (values between 2 and 3 are
optimal) particularly if water solubility is high. In the present case,
the partition coefficient in
octanol/water of 2.1 and the highly water solubility are in favour of a
dermal uptake of the test substance. However this capacity is offset by
the relatively high molecular mass of the substance (422 g/mol):
molecules above 500 g/mol are considered to be too large to penetrate
the skin. Therefore it can be assumed that dermal absorption, if any, is
repeated oral dose toxicity study performed on
cocamidopropylhydroxysultaine (C8-18 carbon chain length), histopathology
evidenced microscopic changes in the stomach, lungs, trachea and
kidneys. In the forestomach, squamous cell hyperplasia was most likely
due to irritant properties of the test item. Pulmonary bronchioalveolar
inflammation and tracheal epithelial alteration were attributed to the
aspiration of compound after regurgitation at dosing. In the kidneys,
there were minimal to slight degeneration/hypertrophy of the tubular
epithelium, principally in males, and minimal tubular vacuolation in
some females. The effects observed in kidneys support
a systemic distribution of the test substance and/or its metabolites or
degradation products. It can be therefore assumed a systemic
distribution of the registered substance.
test, a chromosome aberration test in cultured human lymphocytes, a
mouse lymphoma assay)
and one in vivo (bone
marrow micronucleus test in rats)studies
assessed the potential genotoxicity of Cocamidopropyl hydroxysultaine.
In vitro, the test substance was assessed with and without an exogenous
mammalian metabolic activation system. Under both metabolic conditions,
the test substance showed a similar behaviour and was cytotoxic but non
genotoxic. In the absence of specific metabolism studies, it is not
possible to conclude on the metabolisation potential of the test
substance and thereby of the registered substance.
There is no
indication of a preferred route of excretion for Cocamidopropyl
hydroxysultaine or Lauramidopropyl hydroxysultaine but its high water
and relatively low fat solubility indicate that excretion of unchanged
parent substance and/or metabolites could occur by renal or biliary
routes and that bioaccumulation is unlikely. The parent substance could
not be eliminated via the lungs in expired air due to its low volatility.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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