Registration Dossier

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

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:

 

  • 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.

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.