Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 May 1995 to 31 Jul 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

EC Number:

236-164-7

EC Name:

Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Cas Number:

13197-76-7

Molecular formula:

C17H37NO4S

IUPAC Name:

dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Test material form:

solid

Specific details on test material used for the study:

Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Eleven Wistar rats Crl (WI)BR (5 males and 6 females) were used. Females were nulliparous and non-pregnant.
Weight on receipt: 80-95 g
Age on receipt: approximately 4 weeks
Source: Charles River
Housing: Makrolon cages with sawdust bedding; Up to five animals of same sex per cage
Acclimatisation period: at least five days
Weight at dosing: 111 g (preliminary experiment) 108-124 g (main study)
Temperature: 19-26 degrees C
Humidity: 32-86%
Photoperiod: 12 dark/light cycle
Diet: Standard rat diet UAR A04C, supplied by Usine d’Alimentation Rationnelle, ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test substance administered orally by gastric intubation using metal catheter.
Test substance diluted in bidistilled water immediately before administration.
Single dose at volume of 10 mL/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1 female (preliminary experiment)
5/sex (main experiment)

Control animals:

no

Details on study design:

One female dosed in preliminary experiment. Rat observed twice daily for 7 days.

One group dosed in main experiment which comprised 5 males and 5 females. Rats observed twice daily for 14 days.

Observations included changes in skin and fur, changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, central and autonomous nervous systems, somatomotor activity and behaviour patterns.

Rats were weighed before administration, daily for the first three days and then weekly. Animals were also weighed before being sacrificed.

All animals were sacrificed by carbon dioxide inhalation and subjected to necropsy.

Statistics:

None

Results and discussion

Preliminary study:

No mortality.
Slightly soft faeces observed in the course of the following day post-treatment.
No clinical signs for remaining observation period.
Normal evolution of body weight.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

No mortality at the limit dose

Mortality:

No animals died during the study.

Clinical signs:

other: All animals showed slightly soft faeces in the course of the following day post-treatment. No clinical signs for remaining observation period.

Gross pathology:

No visible macroscopic lesions related to treatment.

Any other information on results incl. tables

No deaths occurred at the limit dose of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

No deaths occurred at the limit dose of 2000 mg/kg bw.

Executive summary:

Betadet S-20 was tested for acute oral toxicity in the rat following oral administration. The study followed EC guideline Part B, Method B1 bis. (29 Dec 1992). Slightly soft faeces were observed on the day following administration. There were no other clinical observations. No mortalities, changes in body weight or gross pathology changes were noted. Betadet S-20 is considered to be free of any significant toxicity and does not require classification according to the CLP Regulation.