Potassium 3-sulphopropyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 January - 12 February 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted May 12, 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

EWG Directive 84/449/EWG, Amtsblatt der Europaeischen Gemeinschaften L 251, Jahrgang 27, 19.9.84, B.1. Akute Toxizitaet - oral /96

Deviations:

no

GLP compliance:

yes

Remarks:

The study was performed in compliance with OECD Principles of Good Laboratory Practice (see Bundesanzeiger Nr. 42a, 2nd March 1983, FRG).

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Potassium 3-sulphopropyl methacrylate

EC Number:

250-466-6

EC Name:

Potassium 3-sulphopropyl methacrylate

Cas Number:

31098-21-2

Molecular formula:

C7H12O5S.K

IUPAC Name:

potassium 3-(methacryloyloxy)propane-1-sulfonate

Test material form:

solid

Details on test material:

- Physical state: solid
- Stability under test conditions: stable as pure test article , article dilution stable for at least 2 hours
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

other: KFM-Han. Wistar (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: males : 234-294 g , females : 184-210 g
- Fasting period before study: 12-18 hours before treatment , approximately 1 hour after treatment
- Housing: animals were caged in groups of five in Macrolon cages type 3 with standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Kliba 343 , Batch 36/85 rat maintenance diet , ad libitum
- Water (e.g. ad libitum): tap water , ad libitum
- Acclimation period: 1 week under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 14-15
- Photoperiod (hrs dark / hrs light): 12/12

IDENTIFICATION: by unique cage number and corresponding colour-coded spots
RANDOMIZATION: animals were randomly selected at time of delivery in groups of five.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

4% solution of CMC in distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle : 4% solution of CMC, carboxymethylcellulose sodium salt purum (Fluka AG) in distilled water
- Amount of vehicle (if gavage): Group 1 : 10 ml at 1000 mg/kg ; Group 2 : 20 ml at 5000 mg/kg

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

DOSAGE PREPARATION (if unusual):
The test article was placed into a glass beaker an a tared Mettler PK 4800 balance, and the vehicle (4 % solution of CMC, carboxymethylcellulose sodium salt purum, Fluka AG, CH 9470 Buchs / Switzerland in distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke and Kunkel, Staufen, FRG).Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Auer-Bittmann, Switzerland) . The preparation was made immediately prior to dosing.

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:

- Duration of observation period following administration: 15 days

- Frequency of observations and weighing:
Mortality : Four times during test day 1, and daily during days 2-15
Body weight : Test days 1 (pre-administration) , 8 and 15
Symptoms : Each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed : All animals were necropsied . All animals were killed by intraperitoneal injection of sodium pentobarbitone.


- Other examinations performed: other:
The animals were checked for the symptoms listed below .
- General behaviour : aggressive,crying,restlessness/excitation,nervousness,fear,sedation,somnolence,sleep,coma
- Respiration : apnea,dyspnea,rales
- Eye : chromodacryorrhea,exophthalmos,miosis,mydriasis,whitish discharge,lid adhesion,lacrimation
- Nose : rhinorrhea,epistaxis
- Motility : akinesia,ataxia,drooped head,hyperkinesia,hypokinesia,paralysis flaccid,paralysis spatic,paddling movements,stiff movements,rolling movements,hunched posture
- Body posture : ventral body position,latero-abdominal position,curved body position
- Skin : erythema,edema,necrosis
- Motor susceptibility : spasms,tonic muscle spasms,clonic muscle spasms,opisthotonus,saltatory spasms,trismus,retching,"Straub" phenomenon,tremor,muscle -twitching
- Various : loss of weight,emaciation,negative corneal reflex,diarrhea,ruffled fur,necrosis of tissue of application area,salivation,pallor,cyanosis

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Clinical signs were noted, but no mortality

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

clinical signs were noted, but no mortality

Mortality:

Males and females :
0% at 1000 mg/kg
0% at 5000 mg/kg

Clinical signs:

other: The following symptoms were observed : 1000 mg/kg : sedation,dyspnea 5000 mg/kg : sedation,dyspnea,diarrhea All rats had recovered within 3 hours to 3 days after test articIe treatment.

Gross pathology:

No macroscopic organ changes were observed in the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

LD50 > 5000 mg/kg

Conclusions:

The study was performed according to the OECD TG401 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1) and so sufficiently reliable to assess the acute oral toxicity of the test item to rats. The test material did not induce mortality up to the highest tested dose of 5000 mg/kg. The test material was hence considered to be non-toxic under the conditions of the test and not requiring classification according to Regulation (EC) 1272/2008.

Executive summary:

The acute oral toxicity of the test material was investigated in rats. 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 15 days. No mortalities or signs of systemic toxicity, besides sedation and dyspnea in the 1000 mg/kg bw group and sedation,dyspnea and diarrhea in the 5000 mg/kg bw group respectively. The animals had recovered within 3 hours to 3 days after administration. No treatment-related body weight changes were reported. No pathological abnormalities were found in any of the treated animals. The acute oral medium lethal dose (LD50) of the test material in rats of both sexes observed over a period of 15 days was estimated to be greater than 5000 mg/kg bw.