Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-11-30 - 1983-12-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
3-(1-Pyridinio)-1-propanesulfonate
IUPAC Name:
3-(1-Pyridinio)-1-propanesulfonate
Constituent 2
Reference substance name:
1-(3-sulphonatopropyl) pyridinium
IUPAC Name:
1-(3-sulphonatopropyl) pyridinium
Details on test material:
- Name of test material (as cited in study report): 1- (3-Sulfoporpyl)-Pyridinium-Betain (Pyridiniumpropylsulfonat/ PPS)
- Name of test material: 1-(3-sulphonatopropyl) pyridinium
- Substance type: organic salt

Test animals

Species:
rat
Strain:
other: rats outbred with Wistarstock KFM:WIST (SPF HAN.)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG/ 4414 Fuellingsdorf, Switzerland
- Age at study initiation: 7 weeks (males), 9 weeks (females)
- Weight at study initiation: 160 - 224 g (males) and 156 - 200 g (females)
- Fasting period before study: fasting overnight
- Housing: the animals were caged in groups of five in macrolon cages with wire mesh tops (Dipl. Ing. W. Ehret GmbH, 7330 Emmendingen, Germany) and standardized granulated soft wood bedding (Lignocel/Schill AG / 4132 Muttenz, Switzerland).
- Diet (e.g. ad libitum): pelleted standard KLIBA 343/BATCH 69/82 rat maintenance diet (Klingentalmuehle AG/ 4303 Kaiseraugust/Switzerland). Defined for acceptable contaminant level, ad libitum.
- Water (e.g. ad libitum): tap water ad libitum (water quality according to the requirements oft he "schweiz. Lebensmittelbuch".
- Acclimation period: 1 week under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IDENTIFICATION: by cage number and individual colour spots
RANDOMIZATION: in order to set up a fully randomized experiment/animals were assigned to the different groups by means of a random algorithm.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 % solution of CMC (Carboxymethylcellulose Natriumsalt purum/ Vise./ 100 CPS/ Fluka AG/ Buchs/Switzerland) in distilled water
- Amount of vehicle (if gavage): 10 mL at 1000 mg/kg and 20 mL at 5000 mg/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL at 5000 mg/kg

DOSAGE PREPARATION: A dilution (w/w) of the test compound was prepared using a homogenizer (Ultra-Turrax/Janke and Kunkel/Staufen/ West-Germany) and kept homogenous during treatment using a magnetic stirrer (Auer-Bittmann/Switzerland).
Doses:
1000 mg/kg bw and 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- single oral intubation via gavage to animals fasted overnight
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded at the day of administration and days 7 and 14 after the administration / Symptoms were assessed five times at day 1 and then daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The LD50 was calculated without use of a statistical model by estimation.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
In both groups no mortalities occurred.
Clinical signs:
In both groups the animals showed ruffled fur (slight) within 1 to 5 hours after dosing. All rats had recovered within 2 observation days.
Body weight:
In both groups no body weight changes were observed.
Gross pathology:
Three male rats of the 5000 mg/kg group showed mottled lungs. Apart from this unspecific finding, no macroscopical organ changes were observed.
Other findings:
No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The study was performed according to the OECD TG401 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. The test material did not induce mortality or treatment-related clinical signs. The test material was considered to be non-toxic under the conditions of the test.
Executive summary:

The acute oral toxicity of the test material was investigated in rats (Ullmann et al,1993). The test was conducted according to OECD TG401. As doses 1000 and 5000 mg/kg bw of the test substance were administered via gavage to the rats. Observations were made for a period of 14 days. No mortalities or signs of systemic toxicity, beside slightly ruffled fur during the first 5 hours following administration were observed. No treatment-related body weight changes were reported. In 3 male animals pathological abnormalities were found: mottled lungs (dose group 5000 mg/kg bw). This findings are not to be considered to be specific, but unspecific. The acute oral medina lethal dose (LD50) of the test material in rats of both sexes observed over a period of 14 days was estimated to be greater than 5000 mg/kg bw.