Potassium 3-sulphonatopropyl acrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 - 20 Aug 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium 3-sulphonatopropyl acrylate

EC Number:

250-465-0

EC Name:

Potassium 3-sulphonatopropyl acrylate

Cas Number:

31098-20-1

Molecular formula:

C6H10O5S.K

IUPAC Name:

potassium 3-(prop-2-enoyloxy)propane-1-sulfonate

Details on test material:

- Name of test material (as cited in study report): SPA, sulfopropyl acrylate
- Physical state: white powder
- Analytical purity: no data
- Lot/batch No.: 0200014/001
- Storage condition of test material: room temperature, in the dark

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD(SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 212-216 g (females) and 207-261 (males)
- Fasting period before study: overnight, until 3-4 hours after dosing
- Housing: animals were housed in groups of 3 by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded diet No.1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: a limit test with 2000 mg/kg bw as the starting dose is recommended, according to OECD 423 - Acute toxic class method, if information on the test substance suggests mortality is unlikely at the highest dose level.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and clinical signs 1/2, 1, 2 and 4 hours after dosing and then once daily for 14 days. The body weight was recorded prior to dosing, and 7 and 14 days after dosing.
- Necropsy of survivors performed: yes, the animals were subjected to gross pathological examination

In the first step 3 females were dosed, and as there was no mortality, in the second step 3 males were dosed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy and gross pathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified