Registration Dossier
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EC number: 242-893-1 | CAS number: 19223-55-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
LD50 (rat, oral) = 3020 (females) or 2950 (genders combined) mg/kg bw
LD50 (mouse, oral) = ca. 3150 mg/kg
LD50 (rat, dermal) > 2000 mg/kg
(expressed as mg active ingredient)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- 2 950 mg/kg bw
- Quality of whole database:
- Three Klimisch score 2 studies in 2 different rodent species (two in rats and one in mice) are available, with consistent study results
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- 2 000 mg/kg bw
- Quality of whole database:
- Recent GLP and OECD test guideline-compliant study (Klimisch score 1)
Additional information
- In the key study (1990), Cocamidopropyl hydroxysultaine was administered by gavage at 1000, 2000 or 3000 mg active ingredient/kg as a 42% active ingredient aqueous solution to 5 rats per gender, kept for a 14-day observation period and then necropsied. A high incidence of pre-terminal deaths occurred at 2000 and 3000 mg/kg, whereas no death occurred at 1000 mg/kg. Marked clinical signs were observed at 3000 mg/kg within 3 days post-dosing. 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. The LD50 was calculated to be 3020 or 2950 mg active ingredient/kg bw, for females or both genders, respectively.
- In one supporting study in rats (1995), Cocamidopropyl hydroxysultaine was administered by gavage at the dose of 2000 mg test solution/kg as a 41.5% active ingredient aqueous solution to 5 animals 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 test solution/kg, equivalent to 830 mg active ingredient/kg. In the other supporting study in mice (1978), Cocamidopropyl hydroxysultaine was administered by gavage at the doses of 6, 7.5 or 10 mL/kg as a 42% active ingredient aqueous solution to 10 animals per dose, kept for a 5-day observation period and then necropsied. Mortality occurred from the lowest dose on, and the LD50 was calculated to be 7.5 mL/kg, equivalent to approximately 3150 mg active ingredient/kg. Using the body surface allometry principles, a dose of 3150 mg/kg in mice is globally equivalent to 1575 mg/kg (half the dose) in rats.
No data is available on the registered substance itself. A read-across was 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.
Three Klimisch score 2 studies were available for oral route. One study in rats was used as a key study and the other two (one in rats and one in mice) used as supporting:
One Klimisch score 2 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 rats.
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
Justification for classification or non-classification
Based on available data on the analog substance cocamidopropylhydroxysultaine, no classification of the registered substance lauramidopropylhydroxysultaine for oral acute toxicity is warranted according to Dir. 67/548/EEC (DSD) or Reg. (EC) No 1272/2008 (CLP) criteria.
Based on available data on the analogue substance cocamidopropylhydroxysultaine, no classification of the registered substance lauramidopropylhydroxysultaine for dermal acute toxicity is warranted according to Dir. 67/548/EEC (DSD) or Reg. (EC) No 1272/2008 (CLP) criteria.
No target organ was identified following a single oral or dermal administration in rats.
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