Registration Dossier

Administrative data

Description of key information

An acute oral toxicity study is available for the submission substance [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts]; a supporting study with the read-across (analogue) substance [Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18 (even numbered) acyl) derivs., hydroxides, inner salts] is also available. Both studies report acute oral LD50 values of >2000 mg/kg bw.

A waiver is provided for acute inhalation toxicity based on exposure considerations.

An acute dermal toxicity study is available for the submission substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A modern, guideline-compliant study is available for the submission susbtance and is supported by older data for the read-across (analogue) substance.

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:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A guideline-compliant study is available for the submission substance.

Additional information

Acute oral toxicity

An acute oral toxicity study with the submission substance Betadet SHR [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts] was conducted using a fixed dose method (Tortajada, 1995). Wistar rats were dosed with 2000 mg/kg bw. A preliminary experiment comprising one female showed no mortality. Soft faeces were noted on the day following treatment. No other clinical signs were noted during the seven day observation period. A main experiment comprised five animals/sex. Soft faeces were noted on the day following treatment. There were no other clinical signs, mortality or post mortem observations. Body weight gain was normal. The overall conclusion of the study was that the test material showed no significant signs of toxicity.

Although not required for this endpoint, a supporting acute oral toxicity study with the read-across (analogue) substance [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts]; this study also reports an acute oral LD50 of >2000 mg/kg bw.

Acute inhalation toxicity

A waiver is provided for acute inhalation toxicity based on exposure considerations.

Acute dermal toxicity

An acute dermal toxicity study with cocamidopropyl hydroxysultaine, as a 36.2% solution (Mackam CBS-50GE) was conduced 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.  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 and age. The dermal LD50 in rats was therefore higher than 2000 mg active ingredient/kg bw.

Justification for classification or non-classification

No classification for acute oral or dermal toxicity is required, based on the results of the available acute oral and acute dermal toxicity studies.